PHARMACEUTICAL and BIOTECH

J. Edgar and Associates Inc. is an industry Leader in Scientific, Clinical and Operations Recruitment at all Levels. If you are currently in the Market for a new employment opportunity, we invite you to view the current opportunities below.

Check frequently for the latest hot jobs...Associate Director...Sr. Process Engineer...RNA Sr. Scientist...Data Scientist...Director...Sr. Manager Biostatistics...Sr. Manager...Director Engineering...


ASSOCIATE DIRECTOR - DOWNSTREAM MANUFACTURING SCIENCE - BIOLOGICS - BOSTON - STRONG SALARY, 20% BONUS AND INCENTIVES - RELOCATION $$$

We are currently seeking an experienced downstream Scientist to lead a team of Engineers and Scientists supporting commercial operations for biologics production. This role requires a strong understanding of Mammalian or Bacterial cell culture processes including a high level of expertise in Chromatography and Filtration. We are looking for someone with strong Technical transfer for NP intros experience and large scale Ion exchange chromatography experience for up to 5 product lines in a state of the art 24/7 production facility.

Responsibilities: Lead a group of Scientists and Engineers to support NPI (new product introduction) and routine commercial production.  Lead Process Validation and Technology Transfer to internal or external manufacturing facilities, as well as FDA prior to approval inspection for commercial license and product launch.   Recommend strategies for improving purification process performance for GMP operations in a multi-product plant. Establish continuous improvement strategies and lead the proposal, initiation, testing, and implementation of changes to purification processes.  Provide a science-based approach and advise members of project teams for the resolution of deviations, investigations, and process issues through analysis of historical data and scale-down studies.  Support FDA audits and provide responses to regulatory questions. Serve as site representative on cross functional teams including the company's MSAT global network teams, technology transfer teams, and CMC project teams. Network with Manufacturing, Quality, and Regulatory organizations to establish a reliable state of process control.  Author and/or review documents (technical memos, protocols, reports, etc.) related to process monitoring programs, at-scale or scale-down studies, annual product reviews, and non-conformances.  Maintain full working knowledge of principles and theories, and advance the understanding and control in both Current and the 2nd Generation commercial processes.  Keep abreast of industrial best practices, and evaluate their potential application across multiple programs within the organization when needed.

Qualifications:  PhD in a scientific discipline (Cell or Molecular Biology, Biochemistry, Chemical Engineering, Biochemical Engineering, or related field) with 8+ years directly related experience in cGMP manufacturing environment or biologics process development. MS with 10+ years. BS with 14+ years of experience. 3+ years of experience managing people. Experience in mammalian cell culture purification techniques with in-depth understanding of large-scale chromatography and UF/DF unit operations, principles of biochemical engineering, and process data analysis. Demonstrated ability to lead technical projects and teams.  Full understanding of compliance and cGMP guidelines. Demonstrated commitment to continuous improvement – at the individual, department and organizational level. Ability to make a significant contribution to cross-functional project teams through technical expertise and scientific creativity. Extensive experience in the process development, technical transfer, process characterization, and operation of large-scale protein purification processes. Direct audit support experience.

Location - Great Boston MA. area

Salary - Strong above market complete package with 20% Bonus plan, 401K plan, LTI, Thorough Health Benefits and robust Relocation package if needed.

Call Jason Edgar at 416 225-2628 for all the details.

Please send your CV directly to me for consideration:
careers@jedgarcareers.com
 


SENIOR PROCESS ENGINEER AND MANAGER - UPSTREAM BIOLOGICS - BOSTON, MA - STRONG PACKAGE!

We are currently seeking an experienced Upstream Process Engineer to manage and support commercial operations  and production of biologic components for two lines of large scale cell culture and/or purification manufacturing.  This position will manage cross functional teams to realize and solve technical issues in production. This position requires hands on experience with; Mammalian cell culture, enzyme, protein, and/or antibody producing cell lines. You will be introduced to one of the leading continuous profusion production systems in the world. Experience in the 500 to 2000 litre bioreactor space would be good to have, however, as this position requires strong scale up and tech transfer experience, the company will consider a strong background in any size of  bioreactor configuration with continuous capture capabilities.

Functional aspects:  Provide collocated technical leadership at manufacturing sites including process monitoring, CPV, root cause investigation, change assessment/change control, debottlenecking, and continuous improvement,    Anticipate, respond to, and permanently resolve issues that arise during production. Aid in design of new processes and facilities with expertise in scale up, manufacturability, PAT, capacity analysis, and cost analysis.  Lead the creation and use of digital process data analytic systems.  Partner with internal and external functions to identify, prioritize, scale up, transfer, implement, validate, and file new product and  process life cycle improvements.

Responsibilities:  Utilize a solid understanding of scientific principles and professional practices to solve a range of complex problems in creative and practical ways. Provide input and coordinate support from process development teams. Coordinate with cross functional teams to progress lab studies. Review manufacturing processes and/or development and production data. Support documentation preparation for regulatory purposes and stay current on regulatory requirements that have impact on manufacturing processes and evaluate/implement changes, if required.   Provide CMC support and guidance for product lifecycle management. Attend development and scientific meetings to remain current with technology and regulatory guidelines. Interact with colleagues from various company functions in particular Engineering, Science, Manufacturing, Quality, and MSAT functions to meet the group’s goals.

Qualifications and Capabilities: Bachelor’s Degree in engineering or science with 9 years of experience or  Master’s degree in engineering or science with 7 years of experience or  Ph.D. in engineering or science with 5 years of experience. You must possess Leadership Qualifications, such as:  Build, manage, motivate, and empower teams and workgroups.  Experience with large scale cell culture or purification manufacturing.  Experience leading cross functional technical teams and leading projects.  Experience communicating with cross functional teams and senior management.  Experience providing solutions for difficult technical issues. Strong technical writing skills.  Experience with high level data analysis and statistical analysis software. Strong root cause analysis and production investigations experience.

Salary - Salary is above market with a 20% yearly Bonus, strong health benefits and 401k plan.

Location - Boston area, MA

Call Cris Murray 416 225-6386, VP Recruitment, J. Edgar and Associates Inc., to apply for this exciting career opportunity.

Please send your CV to me directly for consideration: jedgar@sympatico.ca in either a word or PDF format. Once you submit your CV, I will personally call you back to discuss and disclose our clients details so that you can determine your interest level. 


RNA MACHINE LEARNING - SENIOR SCIENTIST - VACCINE R+D - BOSTON OR TORONTO

In an effort to utilize data to improve Vaccine R&D, we are seeking Data Science and Biological process experts to drive the development of Artificial Intelligence (AI) / Machine Learning (ML) / Deep Learning (DL) solutions to improve efficiency and effectiveness across research and development of the next generation of mRNA based vaccines.

For this role, you must have a deep knowledge and experience in both RNA Biology/Biophysics/Biochemistry and bioinformatics/data science/machine learning and the ability to rapidly transform theory to actionable prototype. You will be responsible for designing, prototyping and validating computational solutions to diverse scientific challenges in the fields of mRNA vaccines and therapeutics.  This role requires a high degree of proficiency in Python/R, machine learning and deep learning libraries, bioinformatics tools and cloud computing.

Responsibilities: Collaborates with stakeholders and other group experts in the development and execution of the scientific strategy and technical solutions to develop best-in-class mRNA vaccines and therapeutics.  Acts as a scientific expert and partner in the fields of RNA biology/biochemistry/biophysics and AI/ML. Leads efforts to design and optimize mRNA vaccines, optimize formulations, predict performance.  Designs and assesses studies to evaluate the performance of mRNA vaccines and therapeutics. Translates experimental learnings into the development and refinement of computational models for design, optimization, selection and formulation of mRNA vaccines.   Develops and evaluates computational and statistical methods for data analysis.  Develops, deploys, and assesses the results of at-scale models at varying levels of model granularity encompassing heterogeneous preclinical and clinical data. Employs machine learning methods such as deep learning, neural networks, reinforcement learning, graphical and generative models to deconvolve high dimensional experimental and in silico modeling results. Maintains a well-documented, reusable codebase, and traceable model history. Generates IP and participates in the drafting of patent filings.

Qualifications:  Advanced degree in computational biology/molecular biology (RNA) with expertise in machine learning or an advanced degree in computational sciences, machine learning or other technical fields with expertise in RNA biology. Deep knowledge and experience in RNA biology/biophysics/biochemistry (structure, function, engineering).   High proficiency in machine learning (Deep Learning, Embeddings, Reinforcement and Transfer Learning) and algorithmic analysis of data. Demonstrated record of transforming algorithms/theory into practical applications delivering robust models that are high performance, interpretable and actionable.  A creative problem solver, skilled in divergent thinking and turning complex data into actionable insights and knowledge. Excellent  communication, scientific writing and presentation skills. Ability to develop and present results as visually appealing and understandable stories. Understanding of drug/vaccine discovery and development processes is a plus.

Location - Boston or Toronto

Salary - Strong above market salary with 15% Bonus, Thorough Health Benefits and 401K/RRSP plan.

Call Jason Edgar at 416 225-2628 for all the details.

Please send your CV directly to me for consideration:
careers@jedgarcareers.com
 


MACHINE LEARNING - DATA SCIENTIST - IMMUNOLOGY/VACCINE R+D - A.I.

We are currently seeking Vaccine R&D entrepreneurial and forward-thinking individuals to drive the development of Artificial Intelligence (AI) / Machine Learning (ML) / Deep Learning (DL) solutions to improve efficiency and effectiveness across research and development with a leading innovator. You will be responsible for applying deep expertise in the mathematics and theoretical underpinnings of machine learning to propose solutions to diverse scientific challenges in vaccinology. These models will range over a large spectrum of learning problems, such as overcoming covariate shift in biological data and active acquisition of data (including under delayed rewards in reinforcement learning settings). The models will be applied across a robust vaccine pipeline, from early-stage pre-clinical research through to clinical trials, to provide insight and generate testable hypotheses. In all cases the goal is to build robust intellectual frameworks with practical and immediate impact.

You must have an advanced mastery of numerical methods in both theory and practice, backed-up by hands-on experience covering advanced algorithms, modeling and simulation, as well as essential scientific programming skills (e.g., Python/R).  This role requires a Scientist with a high level of formal training in machine learning and experience in industrial settings and be ready to hit the ground running in a fast-paced environment that rewards personal initiative, collaboration, and scientific excellence.

Responsibilities: Collaborates with stakeholders and other group experts to translate biological and vaccine development scientific challenges into rigorous quantitative goals. Develops and evaluates computational and statistical methods for data analysis including machine learning model architecture design.  Develops, deploys, and assesses the results of at-scale models at varying levels of model granularity encompassing heterogeneous preclinical and clinical data. Employs machine learning methods such as deep learning, neural networks, reinforcement learning, and graphical models to deconvolve high dimensional experimental data and in silico modeling results.  Acts as a scientific expert and partner in AI/ML. Maintains a well-documented, reusable codebase, and traceable model history. Maintains awareness of the latest developments in relevant fields, evaluates and applies as warranted. Generates IP and participates in the drafting of patent filings.

Qualifications: Undergraduate or higher degree in computational sciences, machine learning, or other technical fields with strong expertise in mathematical modelling and applying quantitative analyses.  Deep expertise in causal inference and counterfactual thinking/analysis, ML (deep learning, embeddings, reinforcement and transfer learning) and algorithmic analysis of data. Practical experience proposing, prototyping and deploying novel algorithms; developing and validating new models.  Ability to process multiple and heterogenous inputs to develop a clear understanding of a problem, issue or potential solution and translate them into practical business opportunities. Excellent analytical and problem solving as well as communication, scientific writing and presentation skills. Ability to develop and present results as visually appealing and understandable stories based on the data. Understanding of drug/vaccine discovery and development processes is a plus, as well as familiarity with RNA biology and RNA-centric techniques/methods.

Location: Boston or Toronto

Salary: Strong above market salary with 15% Bonus and thorough Health Benefits, 401K/RRSP plan.

Call Cris Murray 416 225-6386, VP Recruitment, J. Edgar and Associates Inc., to apply for this exciting career opportunity.

Please send your CV to me directly for consideration: jedgar@sympatico.ca in either a word or PDF format. Once you submit your CV, I will personally call you back to discuss and disclose our clients details so that you can determine your interest level. 


DIRECTOR - REGULATORY STRATEGY FOR SOFTWARE - PATIENT AND DIAGNOSTIC MONITORING - STRONG COMPENSATION - REMOTE USA!

We are currently seeking an experienced Regulatory compliance and strategy specialist to lead the regulatory strategy development and execution for new and innovative software solutions within Ambulatory Monitoring & Diagnostics (AM&D) for a leading global healthcare solutions firm.  The Director will work in collaboration with Business Unit Leaders to lead the development of differentiated, end to end regulatory strategies that ultimately lead to bringing solutions to markets around the world that improve clinical and economic outcomes.

In this role you will be part of the Connected Care AM&D Regulatory Affairs team.  As a result of the organizations renewed dedication to Quality, you will have collaboration with Business leadership colleagues, and you will have access to harness the expertise of 5 Centers of Excellence (COEs).  These COEs specialize in the following capabilities:  Regulatory Affairs, Supplier Quality, Quality Management System, Quality Assurance & Engineering, and Compliance & Audit.  As part of this new organizational structure, you are empowered to use your voice and expertise to have a positive impact on the team, the organization, and health technologies that will improve the health, well-being and care for people around the world.

Responsibilities: Develop and implement the regulatory strategy through deep understanding of the competitive market landscape, regulatory / legislative initiatives, and product marketing strategy for complex regulatory software systems within AM&D. Collaborate with AM&D regulatory affairs leaders and teams as the SME on software and platforms regulatory strategy. Serve as the subject matter expert on competent authority interactions. Collaborating with R&D, marketing, clinical, etc...to ensure regulatory deliverables are submitted per strategy, on time and at the quality expected.

Skills and Experience: Bachelor's degree, higher degree likely to be beneficial. 10 years of experience in the MedTech or Pharmaceutical industry with extensive experience in software and digital health regulatory experience. Experience with successful preparation and submission of 510(k), PMA, or international documents or registration and marketing of medical device software. Consistent track record of working closely with regulators, customers and internal teams to create and execute complex regulatory strategies. Track record of influencing standards and regulator guidance through collaboration and innovative regulatory plans that raise the bar on safety, technical and clinical evidence. Current understanding and experience with global regulations and a consistent record of successful engagements with competent authorities. Experience leading cross functional regulatory agency meetings during all phases of development in the software and digital health domain. Expertise in Standards, Regulations and Legislation interpretation and implementation. Strong background in Design Controls as they relate to regulatory affairs strategy. Excellent working knowledge of medical device regulations (21CFR), FDA law, MDD/MDR, other global laws and regulations. Leadership ability to influence without authority and the ability to work in a highly matrixed environment and collaborate with cross functional stakeholders. Focus on results-based leadership - takes accountability and delivers fast. Excellent written and oral communication skills.

Salary - Competitive to Strong plus a Bonus structure.

Benefits - Robust and thorough health benefits.

Location - Remote USA

Call Jason Edgar at 416 225-2628 for all the details.

Please send your CV directly to me for consideration:
careers@jedgarcareers.com
 


SENIOR MANAGER - BIOSTATISTICS - MEDICAL DEVICE - PMS - GREAT FIRM - EXCELLENT PACKAGE! USA

We are currently seeking an experienced Biostatistician to lead the development and implementation of effective data analysis for quality and safety signals associated to post launch monitoring of product performance in the field. This data is derived from reactive and proactive sources such as; adverse events, product malfunctions, web data scraping and Artificial Intelligence repositories. This position requires the ability to work independently with minimal supervision as well as the ability to guide others in the PD PMS business unit and other internal groups with regard to data analysis.

Responsibilities: Responsible for developing statistical methods needed to effectively monitor PMS data to assure Patient Safety and Product Quality. Responsible for managing the Post market Surveillance trending processes and assuring proper statistical techniques are applied to all trending methods. Responsible for continual review of data that is used for the Trending and Escalation procedure (e.g., calculation of upper control limits). Assures the data integrity of all output via appropriate verification and validation activities. Able to work with data from the trending system and create programs in Python, R, SAS, JMP, Excel, Minitab, etc. to output the data in a manner that is useful for presentation purposes. Ability to explain trending procedures during an audit, if necessary. Establishes statistical tools to analyze data, make acceptance decisions, and improve process capability (Six Sigma, SPC, DOE). Continuously improves Complaint Handling trend reports and reporting to meet changing business needs. With minimal supervision, works with Colleagues from all departments, including Medical affairs, clinicians, engineers, and regulatory Affairs associates, to develop complaint reports that appropriately address questions posed.

In the Role: You may receive technical guidance on complex problems, but independently determines and develops approaches and solutions. With some guidance, you will make decisions on statistical problems and methods, and represent the organization in conferences to resolve important questions and to plan and coordinate work. You will consult with supervisor concerning unusual problems and developments. As an individual researcher, you will carry out assignments requiring the development of new or improved techniques or procedures. Lead and support process improvement projects expected to result in the development of new or improved techniques or procedures. You will ensure compliance with the company's Quality System policies and procedures and applicable external requirements and standards, including FDA, ISO 13485, MDSAP, EUMDR, etc.

Skills and Experience: BS or higher in Statistical or Mathematics sciences. Must possess understanding of engineering and statistics fundamentals. American Society for Quality (ASQ) certification, Data Scientist certification, Six Sigma knowledge is desirable. 5-10 years of experience in the pharmaceutical / medical device industry. Medical device experience preferred with a collaborative patient and customer focus mindset. You should have the ability to lead cross-functional and cross-business teams as well as experience interacting with the FDA, ISO, and Other Regulatory Authorities. Strong communication skills both oral and written and you must have adequate computer skills to evaluate trending data, complete regulatory reports, and provide written correspondence to internal and external customers including regulatory bodies as appropriate.  Experience supervising others is preferred.

Salary - Strong and above market plus a Bonus structure.

Benefits - Thorough and Robust.

Location - Remote working - USA based.

Call Cris Murray 416 225-6386, VP Recruitment, J. Edgar and Associates Inc., to apply for this exciting career opportunity.

Please send your CV to me directly for consideration: jedgar@sympatico.ca in either a word or PDF format. Once you submit your CV, I will personally call you back to discuss and disclose our clients details so that you can determine your interest level. 


SENIOR MANAGER - MEDICAL DEVICE - MECHANICAL AND HW - R+D - INNOVATIVE FIRM  - SAN DIEGO, CA - ABOVE MARKET SALARY AND BONUS WITH ROBUST BENEFITS PKG.

We are currently seeking an experienced  R+D Manager to understand market and customer needs in efforts to develop new Infusion products and platforms. This role will work with suppliers and internal cross functional teams to develop new solutions and sustain existing technologies including Next generation models. This position will focus on leading the Mechanical and Hardware development team through research and development of new Infusion product concepts and technologies.

Responsibilities: Provide strategic and tactical leadership to the team in the achievement of department, division, and corporate goals, enhancing technical staff skills, expanding capabilities of labs, and cultivating customer engagements in an effort to develop Next Gen Infusion products. Expand engineering, problem-solving, and lean Agile development techniques and improve skill sets in Design for Six Sigma development methodologies. Interface with customers and translate their needs into product requirements. Explore the need and possible growth for system modeling, predictable models & Monte Carlo analysis. Provide Engineering expertise to both direct staff and supported product development programs in the area of complex systems design (Mechanical/Electrical focus).

Tools to Succeed: An advanced degree in Engineering, Business, or equivalent experience. A broad technical background and demonstrated expertise in device engineering: examples include Mechanical Design, Electro/Mechanical Design, Systems engineering. Experience developing safety-critical medical device systems, working with multi-disciplined teams, and a large-scale system of systems. Experience across the entire device lifecycle, from inception, through design, prototyping, testing, manufacturing and commercial launch. Experience working in a program office and Virtual environment which includes contract design and manufacturing partners. Previous experience managing highly skilled, technical professionals.

Qualifications: Bachelor's degree in Electrical or Mechanical Engineering or other related technical fields of study; Systems Engineering focus preferred. Strong technical leadership skills. 7 or more years of experience in product development and product life cycle management. A demonstrated track record of technical leadership and delivering results. A strong technical background and demonstrated expertise in design of complex electro/mechanical medical devices. Excellent oral, written, and interpersonal communication skills.

LOCATION - Southern California - San Diego   

Call Jason Edgar at 416 225-2628 for all the details.

Please send your CV directly to me for consideration:
careers@jedgarcareers.com
 

DYNAMIC DIRECTOR ENGINEERING-PROJECT LEADER-MAJOR CAPITAL PROJECTS, GTA

We are currently seeking an experienced and polished hands-on Director of Engineering working on Major Capital Projects within a Global Biopharmaceutical innovative leader. Mentor, define and delegate requirements with best practices in driving the Technology Innovation and implementation within the project by utilizing the latest technology design with Robots and Automation. In this career role, the Engineering Project Leader reports functionally to the Global Head of Engineering Technical Services. The project Leader will be responsible for an end-to-end execution of design/construction and Commissioning and Qualification of the new facility.

In this role, you will lead and build a high performing multi-disciplinary and cross-functional project engineering organization of approximately 10-12 direct reports and up to 500 contractors. Lead the strategic project plan for the large capital project and ensure key decisions in accordance with safety, quality, performance, and costs objectives of the company.

Optimize and drive technology innovation and implementation within the project is the major mandate. Manage the project controlling strategy in accordance with company policies. Establish methods and tools for efficient project execution including adequate monitoring of schedule. Manage an escalation process of project issues to project sponsor/team per established governance.

Promote efficiency gains and improve working methods throughout lifecycle of the project, including schedule and cost/budget. Ensure alignment with all the stakeholders and contractors whenever there is a change in strategy or direction. Manage multiple interfaces between projects, Site Leadership Team, Global Functions, and Executive Leaders.

Must have: Minimum BS in Engineering, Leading Capital Projects of Aprox. 500 Million, Process Engineering, project management, controls, Information Systems, Procurement, Safety, Human Resources.

Necessary skills to be successful in this role: 10 years of project management experience in pharmaceuticals (preferred), life sciences, Chemicals or petroleum sector, across multiple functions (Engineering, Process, Validation, Operations, Quality). Bring your time management, continuous quality improvement, relentless advocacy for Technology Innovation with a focus on meeting company project milestones within Capital Projects, and we have a career for you.

Location: Greater Toronto area, Canada. A combination of office and home based to be successful. Salary: Above Market plus target bonus plan including a thorough and comprehensive benefits package.

Call Cris Murray 416 225-6386, VP Recruitment, J. Edgar and Associates Inc., to apply for this exciting career opportunity.

Please send your CV to me directly for consideration: jedgar@sympatico.ca in either a word or PDF format. Once you submit your CV, I will personally call you back to discuss and disclose our clients details so that you can determine your interest level.


HUMAN RESOURCES MANAGER - NORTH GTA - SUCCESSFUL AND GROWING FIRM - $100-130K PLUS 10% BONUS

We are currently seeking an experienced Human Resource Manager to manage: Employee relations, Recruitment, Training, benefit administration, Record Keeping, Health and Safety (in an office environment), Compensation and Consultant management.

Key Accountabilities in Recruitment include: Creating job postings, advertising open positions on various web sites and interacting with recruitment agencies, pre-screening resumes with department managers, conducting candidate screening, assisting the department management team with technical interviews, administering skill-based tests, managing background check, applicant tracking and preparing offer letters while providing new hire information to the payroll department.

Key Accountabilities in Training include: Provide on boarding training and facilitate the gathering of new compliant employee documentation,  employment verification forms, personal information, and confidentiality agreements. Administer background check Firms, administer refresher training on HR policies.

Key Accountabilities in Benefit Administration: Providing employee education on the health and welfare benefit plans and the RRSP plan. Act as the employee point of contact for any benefits and RRSP questions and changes. Perform Benefit administration duties (setting up new hires, ending enrollment for terminated employees, etc.). Assist with Disability/Leave of Absence (LOA) management. Make changes to employee benefits if required during the open enrollment period.

Key Accountabilities in Employee Relations, Compensation, Health and Safety, Record Keeping and Consultant Management include: (This list is constantly developing as the organization navigates itself in current and post pandemic operations) Participate and Lead the social and recreation committee, organize conference lunches, staff outings and year end parties. Develop other employee relation activities and enhancements. Be the point of contact for any staff related employee relation issues. Conduct “check-in” discussion with new employees following 3 months of service and conduct exit interviews when someone is leaving the company. Keep abreast of Employment Law, advocate new change and update HR and Management team internally. Strong SOP writing skills to write new HR policies when required.  Assist the Sr. Director and Ass. Director of Human Resources in the establishment of position ranking, maintain regional salary ranges and establishing salary ranges in states where we currently do not have employees. Track annual performance and salary reviews and advise and follow up with Managers to ensure they are conducted in a timely manner. Management representative on the Health and Safety Committee. Perform monthly safety audits. Ensure company is in compliance with OHSA rules and regulations. Maintain employee files and ensure accurate employee records are kept up to date. Manage and oversee the HRIS administration. Provide semimonthly checks on employee timesheet reports and follow up with employees on any discrepancies. Oversee vacation and other absence tracking and record keeping. Develop and Manage consultant contracts. Assist the finance department as required.

Qualifications and Experience: B.A., B.Comm or another pertinent degree in Business Administration with CHRP Certification OR a post graduate Certificate in Human Resources. At least 5 years of experience in a Senior Human Resources role or experience as Human Resource Manager. The ideal candidate has experience with all eight areas of Key Responsibility: Recruitment, Employee Relations, Training, Benefit Admin., Compensation, HSE, Records and Consultant Management.

Salary - $100-130K plus 10% Bonus plus RRSP contribution plan. Location - Greater Toronto Area 3 weeks Vacation.

Call Cris Murray 416 225-6386, VP Recruitment, J. Edgar and Associates Inc., to apply for this exciting career opportunity.

Please send your CV to me directly for consideration: jedgar@sympatico.ca in either a word or PDF format. Once you submit your CV, I will personally call you back to discuss and disclose our clients details so that you can determine your interest level.


STAFF MANUFACTURING ENGINEER - NEW PRODUCT INTRO'S - GREAT FIRM IN THE BAY AREA - ABOVE MARKET SALARY WITH BONUS!

We are currently seeking a Staff Manufacturing Engineer who will lead Operations cross functional teams responsible for identifying manufacturing requirements, ensuring successful product design transfer and commercial launch for multi-year new product development programs.

We are looking for an experienced Manufacturing engineer with a proven track record of sustained success in the execution of complex cross functional new product development programs.

Functional Responsibilities: Demonstrates project management best practices and contributes to improving the product development process. Supports the introduction of new products into manufacturing as a member of a NPI program team representing Operations. Engages in prototypes and pilots in order to establish processes and assembly documentation. Reviews engineering designs and documentation for completeness, clarity and manufacturability. Evaluates and qualifies new suppliers. Trains production personnel. Leads teams to prepare Go/No-Go decisions by executive leadership, ensuring that decisions are informed by a balanced and clearly articulated representation of the relevant data. Ensures alignment of product value proposition, program scope, and strategic business objectives. Leads project planning process ensuring manufacturing requirements are clear and driven by need and experience. Defines, delegates and evaluates the roles, responsibilities, goals and deliverables for core and extended team members. Independently determines and pursues courses of action necessary to obtain desired results. Communicates program updates to functional management. Defines program resource/budget needs and negotiates program resourcing/budget plans. Leads key operation excellence reviews, constructively challenging the team and the organization to rethink assumptions and approach headwinds in new ways. Leads cross-functional teams through identifying program risks and forming mitigations to support a timely delivery of program milestones. Leads cross-functional teams through problem resolution, including root cause analysis and corrective action. Works with functional leaders to ensure the appropriate team members contribute to required performance levels. Ensures effective and efficient regular formal and informal communications using a variety of tools and channels.  Leads product development utilizing a multitude of processes including a Global Product Delivery System, Voice of the Customer/Business, Project Management, DFX, and Agile. Leads, directs, coaches, and mentors Core Team members to maximize project success. Ensures programs comply with company quality management systems while identifying creative ways to provide speed to market. Builds high morale and ensure the team commits to goals and objectives by creating a common purpose and direction.

Qualifications: Possess the skills and aptitude to engage, influence, and direct all functions involved in the development of new products. Anticipate and understand implications across all functions. Excellent influencing skills with the ability to achieve challenging goals through others without direct authority across different functions, geographies and cultures. Drive for accountability within self and others. Ability to lead complex programs delivering the right outcomes balancing on time delivery, budget, quality and market and customer expectations. Highly skilled in integrated program planning along with tactical project planning, risk management, project execution and communication to all levels of the organization. Ability to take disparate data points and make sound business decisions and bring clarity to ambiguous situations. Look at the big picture and the long range with an instinct for trade-offs (i.e. user experience vs. technical aspects / short vs. long term / risk vs. reward / resources vs. budget). Thrive in dynamic environment demonstrating high learning agility, being skilled at rapidly applying lessons learned to practice. Time management, self-control, continuous learning, drives for order yet flexible and nimble. Versatility of thought and action in unanticipated circumstances using structured tools at his/her disposal to respond effectively and resolve unanticipated changes.

Experience and Educational Requirements: Bachelor’s degree in ME, EE, IE, or Engineering degree or an MBA or other advanced business/management degree preferred. PMP, Six Sigma, DFX certification or equivalent beneficial. Minimum of 4 -10 years of experience in successfully leading complex, multiyear new product development programs delivered through high performing, cross-functional, teams based in a matrix organization. Master’s degree may be considered in lieu of experience. Experience in medical device or life science industries required. Management of whole systems development covering hardware, firmware, software preferred. Exceptional analytical, critical thinking and problem-solving skills coupled to strong business, strategic and financial acumen. Highly effective interpersonal skills on a cross-cultural level with excellent oral, presentation and written communication skills, including engagement with Executive level management.  Exceptional leadership qualities consistently delivering results. Inspirational and motivational balancing accountability with mentorship and support. Strategic and yet able to comprehend and manage details. Expert in balancing risk with progress and a timely path for escalation.

Salary: Strong and above market plus 12% Bonus, Benefits: Full and thorough Health Benefits plan, Location: San Francisco Bay Area, California

Call Cris Murray 416 225-6386, VP Recruitment, J. Edgar and Associates Inc., to apply for this exciting career opportunity.

Please send your CV to me directly for consideration: jedgar@sympatico.ca in either a word or PDF format. Once you submit your CV, I will personally call you back to discuss and disclose our clients details so that you can determine your interest level.


SR. PROGRAM MANAGER-NEXT GENERATION SEQUENCING-SAN DIEGO

We are currently seeking an experienced and polished New Product Improvement Development and Team Program Manager who will lead cross-functional teams to prepare for Phase Gate with relevant data to achieve commercial launch for new product development programs. Mentor, define and delegate requirements with best practices in improving the product development process and deliverables for core and extended teams.

We are currently seeking an experienced and polished New Product Improvement Development and Team Program Manager who will lead cross-functional teams to prepare for Phase Gate with relevant data to achieve commercial launch for new product development programs. Mentor, define and delegate requirements with best practices in improving the product development process and deliverables for core and extended teams.

In this role, you will ensure alignment of product value proposition, program scope, and strategic business objectives. By leading the program planning process, you will ensure requirements are clear and driven by customer needs and experiences. Defining program resource/budget needs with cross functional teams and communicating program updates to executive management, will help identify program risks, ensure a timely delivery of program milestones and problem resolution, including business excellence, personal effectiveness, project and cross functional leadership and optimized execution and  performance.

Lead key technical design and commercial excellence reviews, constructively challenging the team for continuous product improvement initiatives to achieve maximum project success. Leads product development utilizing a multitude of processes including Project Management, Agile and other in house systems. Leads, directs, coaches, and mentors Core Team members to maximize project success by providing significant feedback to functional leaders regarding the performance of Core Team members that is considered in annual performance evaluations.

Must ensure programs are compliant with company’s Global Quality Management Systems while identifying creative ways to provide speed to the market in this Global organization. Building high morale, creating clear and common objectives for the purpose of facilitating harmonious team dynamics will help foster development in cross-functional teams and reach new Global product development milestones.

Ability to lead complex programs delivering the right outcomes balancing on time delivery, budget, Quality and market and customer expectations is the key to the success of this role. You must be highly skilled in integrated program planning along with tactical project planning, risk management, project execution and superior communication to all levels of the organization.

Bring your time management, continuous quality learning, relentless advocacy for the customer with a focus on meeting customer requirements to the table and we have a new and exciting career for you!

Education: Bachelor’s degree in technical field. MBA or PMP or similar is considered an asset.

Qualifications: Minimum of 5-10 years’ experience successfully leading complex, multi-year new product development programs delivered through high performing, cross-functional, teams based in a matrix organization. Experience in Medical Devices or life sciences industries is advantageous, including management of whole systems development covering hardware, firmware, software and reagents is strongly preferred. Exceptional analytical, critical thinking, problem solving coupled with strong business, strategic and financial acumen is considered a must have in this career role.

Location: San Diego, California. A combination of office and home based to be successful in this role.

Salary: Above Market plus target bonus plan including a thorough and comprehensive benefits package.

Call Jason Edgar at 416 225-2628 for all the details. Please send your CV directly to me for consideration: careers@jedgarcareers.com 


STAFF ENGINEEER - MED TECH CLASS II - RELIABILITY - BAY AREA - GREAT FIRM AND PACKAGE

We are currently seeking an experiences Reliability engineer for a set of Class 2 Medical device instruments with multi-integrated systems; fluidic, optical and/or electromechanical systems. This role will play a meaningful role in the development of new life sciences technology as a reliability Engineer, enabling products to realize their promise to improve human health.

In this role you will guide project teams through defect prioritization, failure analysis, root cause investigation, corrective action implementation and final validation. The mandate is to assess program and technical risk through data driven statistical analysis and facilitate best practices to ensure robust design, detailed risk assessment and cross functional transparency and alignment and steward the customer experience, design quality and reliability.

Responsibilities: Oversee and monitor multiple reliability projects, Provide reliability risk assessments to cross-functional teams and executive leadership, Build and implement test plans to optimally mitigate risks in new product designs, Facilitate and direct multidisciplinary discussions to evaluate technical risk through FMEA. Author and execute test plans and protocols. Leverage internal and external resources to complete reliability test plans. Record, organize, and manage large amounts of detailed test data. Methodically analyze test data and interpret results for critical reliability decision-making. Troubleshoot instrument failures and/or reliability issues as necessary. Provide engineering input for new designs to ensure reliable and robust products. Direct, execute, and document root cause investigations. Guide the team to corrective action identification, implementation, and validation. Escalate top issues by providing clear, well-structured, high-level updates. Be a champion for best practices in R&D.

Qualifications, Skills and Assets: Bachelor's degree in an engineering or related discipline required. Minimum of 8 years' experience performing tests to collect experimental data and performing statistical analyses to interpret results. Minimum of 5 years' experience in reliability engineering. Knowledge of reliability fundamentals and understanding of reliability analysis (i.e., life predictions, product life modeling, root cause analysis, environmental testing, accelerated testing, etc.) Knowledge and/or experience with fluidic, optical, and/or electro-mechanical systems strongly preferred. Willingness to prepare blood samples for testing (training will be provided). Excellent communication skills. Demonstrated ability to perform detail-oriented work with a high degree of accuracy. Assets: Advanced degree in Engineering related discipline strongly preferred. Experience leading reliability engineering projects with cross functional teams strongly preferred. Experience with test automation (LabView, Arduino, etc.). Demonstrated ability to utilize test and measurement equipment. Experience utilizing FMEA to guide team discussions and priorities. Technical writing for the preparation of protocols, plans and reports. Advanced statistical knowledge, especially related to six sigma tools and methodology, design of experiments, and reliability modeling. Experience managing large sets of data using data processing tools such as Minitab, MATLAB, JMP, or R.

Location: Bay Area, San Francisco - Salary: Above market with Bonus and 401k plan - Health Benefits: Full and thorough health benefits plan.

Call Cris Murray 416 225-6386, VP Recruitment, J. Edgar and Associates Inc., to apply for this exciting career opportunity.

Please send your CV to me directly for consideration: jedgar@sympatico.ca in either a word or PDF format. Once you submit your CV, I will personally call you back to discuss and disclose our clients details so that you can determine your interest level.


SENIOR MANUFACTURING ENGINEER - NEW PRODUCT INTRO'S - GREAT FIRM IN THE BAY AREA - ABOVE MARKET SALARY WITH BONUS

We are currently seeking a Senior Manufacturing Engineer who will drive the design transfer of a new product in a med tech instruments manufacturing team. This position requires the ability to deliver good and substantiated judgement with little supervision and lead change while contributing to new ideas and finding innovative methods to accomplish goals while getting things done through people that are not direct reports.

We are looking for a Manufacturing engineer who can assist in product design using DFX with the Engineering design team, followed by transferring such design to downstream operations including Production, Supply Chain, Service, Master Data, Documentation Systems and the Customer.

Functional Responsibilities: Supports the introduction of new products into manufacturing as a member of a NPI program team representing Operations. Engages in prototypes and pilots in order to establish processes and assembly documentation. Reviews engineering designs and documentation for completeness, clarity and manufacturability. Evaluates and qualifies new suppliers. Trains production personnel. Leads an extended team of Production, Supply Chain, Service, Document Control, Quality, Material Handling, Logistics, and Supplier representatives in transferring designs to manufacturing. Supports sustaining engineering activities as a key member of, and sometimes leads, cross-functional project teams in Operations. After NPI launch, the manufacturing engineer’s follow-on objectives include: improving manufacturing operational efficiency, optimizing product design, qualifying replacement components or suppliers, improving product quality, improving customer satisfaction, maintaining a lean manufacturing environment, or reducing manufacturing costs. Provides manufacturing process requirements and best practices to other project teams in ensuring Production readiness. Provides hands-on support to the manufacturing assembly and test processes for cutting edge cellular and molecular screening instruments. Determining root cause of difficult technical issues. Must be able to implement effective solutions in a timely manner. Issues are typically multi-disciplinary in nature: mechanical, optical, electrical, and fluidic. May engage in internal and field failure investigations, identifying root cause, and participating in corrective and preventative action efforts. Keeps abreast of the basic requirements for EMC, safety and environmental compliance in own area of work and complies with those requirements. Participates as required in training on regulatory issues affecting own area of work. Brings regulatory compliance questions/issues to the attention of management. Understands product structures, manufacturing models, engineering drawings, Bills of Materials, operational procedures, shop-floor and material movement controls and routings. Authors and manages Engineering Change Orders from initiation to implementation.

Experience and Educational Requirements: BS degree: ME, EE, IE, IT or equivalent, 3-6+  years’ experience in a high-tech medical device manufacturing environment, Excellent written and verbal communication and interpersonal skills: conflict resolution, negotiation, and time management skills, Must be able to understand engineering drawings, Bills of Materials, and operational procedures, Experience developing manufacturing processes, writing procedures, and training assembly personnel, working with quality and reliability teams to conduct risk analyses, FMEA reviews and able to define critical-to-quality criteria and present IQ/OQ/PQ test plans for proposed changes or solutions. Willingness to travel to suppliers up to 10%

Qualifications that will help in the Role: Proficiency with some of the following applications:  SolidWorks, Creo/Pro-E, AutoCAD, MS Project, MS Access, SAP ERP, Minitab, Experience resolving technical issues involving lasers, optical components, fluidic systems or digital/analog circuitry. Experience supporting some of the following commodities or supplier types: lasers, optical components, fluidic systems, machined parts, sheet metal, cables, PCA’s, plastics, power systems, product packaging, turnkey subcontractors, hardware, labeling cGMP familiarity 21 CFR part 820, medical device manufacturing experience. Experience implementing Demand Flow Technology (DFT) processes Experience implementing LEAN manufacturing processes, 6 Sigma green or Black Belt.

Salary: Strong and above market plus 5% Bonus

Benefits: Full and thorough Health Benefits plan

Location: San Francisco Bay Area, California

Call Jason Edgar at 416 225-2628 for all the details. Please send your CV directly to me for consideration: careers@jedgarcareers.com 


MANUFACTURING PROJECT MANAGER - MED TECH - NEW PRODUCT INTROS - GREAT FIRM! Bay Area.

We are currently seeking a Manufacturing PM with experience leading operational cross functional teams responsible for identifying manufacturing requirements, ensuring successful product design transfer and commercial launch for multi-year product development programs.

We are seeking an innovative, passionate and highly capable individual with a proven track record of sustained success in the execution of complex cross functional new product development programs due to the direct visibility this position will have with executive leadership in this highly progressive environment.

Functional Responsibilities: Project management best practices and contributes to improving the product development process. Leads teams to prepare Go/No-Go decisions by executive leadership, ensuring that decisions are informed by a balanced and clearly articulated representation of the relevant data. Ensures alignment of product value proposition, program scope, and strategic business objectives. Leads project planning process ensuring manufacturing requirements are clear and driven by need and experience. Defines, delegates and evaluates the roles, responsibilities, goals and deliverables for core and extended team members. Independently determines and pursues courses of action necessary to obtain desired results. Communicates program updates to functional management. Defines program resource/budget needs and negotiates program resourcing/budget plans. Leads key operation excellence reviews, constructively challenging the team and the organization to rethink assumptions and approach headwinds in new ways. Leads cross-functional teams through identifying program risks and forming mitigations to support a timely delivery of program milestones. Leads cross-functional teams through problem resolution, including root cause analysis and corrective action. Works with functional leaders to ensure the appropriate team members contribute to required performance levels. Ensures effective and efficient regular formal and informal communications using a variety of tools and channels. Leads product development utilizing a multitude of processes including a proprietary Global Product Delivery System, Voice of the Customer/Business, Project Management, DFX - Design for Excellence, and Agile. Leads, directs, coaches, and mentors Core Team members to maximize project success. Ensures programs comply with company quality management systems while identifying creative ways to provide speed to market. Builds high morale and ensure the team commits to goals and objectives by creating a common purpose and direction.

Skills to Succeed: Ability to set clear objectives and measurements while facilitating team dynamics. Ability to foster  development in others while creating strong morale and spirit on teams. Share wins and successes and foster constructive challenge and thrive in achieving success through others. Possess the skills and aptitude to engage, influence, and direct all functions involved in the development of new products. Anticipate and understand implications across all functions. Excellent influencing skills with the ability to achieve challenging goals through others without direct authority across different functions, geographies and cultures. Drive for accountability within self and others. Ability to lead complex programs delivering the right outcomes balancing on time delivery, budget, quality and market and customer expectations. Highly skilled in integrated program planning along with tactical project planning, risk management, project execution and communication to all levels of the organization. Ability to take disparate data points and make sound business decisions and bring clarity to ambiguous situations. Look at the big picture and the long range with an instinct for trade-offs (i.e. user experience vs. technical aspects / short vs. long term / risk vs. reward / resources vs. budget). Ability to thrive in a dynamic environment demonstrating high learning agility, being skilled at rapidly applying lessons learned to practice while maintaining Time management, self-control, continuous learning and drives for order yet flexible and nimble. Versatility of thought and action in unanticipated circumstances using structured tools at his/her disposal to respond effectively and resolve unanticipated changes. Advance long-term growth while consistently meeting or exceeding near-term business performance expectations. Ability to effectively apply business, financial and commercial knowledge to successfully deliver target product development outcomes. Relentless advocacy for the customer with a focus on meeting or exceeding customer requirements. Driving the team to make trade-offs that optimize customer and business value while maintaining program velocity and outcomes that sustain the highest standards of quality.

Experience and Educational Requirements: Bachelor’s degree in a technical field required, an MBA or other advanced business/management degree preferred. PMP, Six Sigma, DFX certification or equivalent beneficial. Minimum of 3-6 years of experience in successfully leading complex, multiyear new product development programs delivered through high performing, cross-functional, teams based in a matrix organization. Minimum 2 years of experience in R&D or Manufacturing Engineering, Experience in medical device or life science industries required, Management of whole systems development covering hardware, firmware, software preferred  Exceptional analytical, critical thinking and problem-solving skills coupled to strong business, strategic and financial acumen. Highly effective interpersonal skills on a cross-cultural level with excellent oral, presentation and written communication skills, including engagement with Executive level management.

Salary: Above market plus 10-15% Bonus plus 401K - Benefits: Thorough Health Benefits Plan - Location: Bay Area, California

Call Cris Murray 416 225-6386, VP Recruitment, J. Edgar and Associates Inc., to apply for this exciting career opportunity.

Please send your CV to me directly for consideration: jedgar@sympatico.ca in either a word or PDF format. Once you submit your CV, I will personally call you back to discuss and disclose our clients details so that you can determine your interest level.


PRINCIPAL SOFTWARE ENGINEER - DEVELOPMENT INFRASTRUCTURE AND OPERATIONS - LEADING MEDICAL TECHNOLOGY FIRM - BAY AREA - EXCELLENT PACKAGE!

We are currently seeking an experienced Software build infrastructure developer and Engineer to create and optimize the Development and Operations of new software for some of the most cutting edge Medical Technology currently in development.

The goal in this role is to be the Technical lead enabling streamlined software development, by managing and owning the entire build pipeline, DevOps toolchain and associated test environments from source control to software delivery. We are looking for a experienced Software engineer with proven success in creating a software Development and Operations infrastructure. Ideally, we are looking for solid experience creating DevOps infrastructure using Docker and Chef. See the full Tech and Tools listed below.

Responsibilities: Work very closely and integrate with the Development team to embrace culture change. Work with peer technical leaders and their teams to enable engineers to seamlessly create CI/CD pipelines for their software components. Focus on continuously improving the DevOps tooling and software delivery processes. Own and maintain highly reliable environments and toolchains with clear communication and timeliness of any disruptions to internal stakeholders. Leverage industry-standard techniques and processes to help enable and provide better feedback to the development community. Monitor and continually improve the capacity of our production environments infrastructure. Investigate and fix performance and scalability bottlenecks.

Experience: Minimum of a Bachelor's Degree in Computer science, IT, Software Engineering, or related discipline. Minimum of 7 years’ experience in Software Engineering development roles. Minimum of 3 years' experience maintaining and managing software build infrastructure. (i.e. Azure DevOps, Jenkins, TravisCI, TFS, TeamForge, etc.) Minimum of 3 years' experience with container technology and subsequent technologies (Docker, Kubernetes, Docker Swarm, Amazon ECS, Azure Service Fabric, Harbour, Helm, Packer, Terraform) Strong experience creating, maintaining, and supporting automated build pipelines. Strong experience in version control and source control management (Subversion, TFVC, Git) Experience deploying, managing, and maintaining at least 2 of the following SCM tool chain such as Jenkins, Artifactory, SonarQube, Nexus, TFS. Strong understanding of programming skill sets, structure, and Versioning. Strong working knowledge of MSBuild. Experience in an object-oriented programming language (Java, C++, C#, etc..) Experience in scripting languages such as Bash and Python. Experience and knowledge of Microsoft system administration and networking. Knowledge of test-driven development, software configuration management, and automated testing.  Experience managing a VMware-based virtualization environment or similar.

Assets for this role: Experience with system management technologies such as Puppet, Ansible, Salt, or Chef. Experience in managing an automated build pipeline for a mixed set of software assets. Strong interpersonal skills (verbal and written). Experience using Wix and/or InstallShield.

Salary - Above Market - Bonus - 10-15% - Location - San Francisco Bay Area, CALIFORNIA -

Call Jason Edgar at 416 225-2628 for all the details. Please send your CV directly to me for consideration: careers@jedgarcareers.com 


 R+D NEW PRODUCT DEVELOPMENT & PROJECT/PROGRAM MANAGER- BAY AREA-CALIFORNIA

We are currently seeking an experienced and polished R+D New Product Improvement Development and Team Program Manager who will lead teams to prepare for Phase Gate with relevant data to achieve commercial launch for new product development programs. Mentor, define and delegate requirements with best practices in improving the product development process and deliverables for core and extended teams.

In this role, you will ensure alignment of product value proposition, program scope, and strategic business objectives. By leading the program planning process, you will ensure requirements are clear and driven by customer needs and experiences. Defining program resource/budget needs with cross functional teams and communicating program updates to executive management, will help identify program risks, ensure a timely delivery of program milestones and problem resolution, including root cause analysis and corrective action plan.

Lead key technical design and commercial excellence reviews, constructively challenging the team for continuous product improvement initiatives to achieve maximum project success. Leads product development utilizing a multitude of processes including Project Management, Agile and other in house systems. Leads, directs, coaches, and mentors Core Team members to maximize project success by providing significant feedback to functional leaders regarding the performance of Core Team members that is considered in annual performance evaluations.

Must ensure programs are compliant with company’s Global Quality Management Systems while identifying creative ways to provide speed to the market in this Global organization. Building high morale, creating clear and common objectives for the purpose of facilitating harmonious team dynamics will help foster development in cross-functional teams and reach new Global product development milestones.

Ability to lead complex programs delivering the right outcomes balancing on time delivery, budget, Quality and market and customer expectations is the key to the success of this role. You must be highly skilled in integrated program planning along with tactical project planning, risk management, project execution and superior communication to all levels of the organization.

Bring your time management, continuous quality learning, relentless advocacy for the customer with a focus on meeting customer requirements to the table and we have a new and exciting career for you!

Education: Bachelor’s degree in technical field. MBA or PMP or similar is considered an asset.

Qualifications: Minimum of 5-10 years’ experience successfully leading complex, multi-year new product development programs delivered through high performing, cross-functional, teams based in a matrix organization. Experience in Medical Devices or life sciences industries is advantageous, including management of whole systems development covering hardware, firmware, software and reagents is strongly preferred. Exceptional analytical, critical thinking, problem solving coupled with strong business, strategic and financial acumen is considered a must have in this career role.

Location: Bay Area, California. A combination of office and home based to be successful in this role.

Salary: Above Market plus target bonus plan including a thorough and comprehensive benefits package.

Call Jason Edgar at 416 225-2628 for all the details. Please send your CV directly to me for consideration: careers@jedgarcareers.com 


DIRECTOR, US ONCOLOGY REGULATORY AFFAIRS-NJ, MA OR REMOTE

We are currently seeking an experienced filing lead to act as the Regulatory Affairs  Director for US Oncology.

In this Director of North America Regulatory Strategy (NA GRA) role, the incumbent will be primarily responsible for the development of innovative and robust US Regulatory strategies for pipeline and lifecycle assets in a growing Oncology portfolio. You will be accountable for the efficient and effective execution of US regulatory strategies while adhering to US regulatory and corporate guidelines. The US RA Lead will serve as Liaison to the US FDA for assigned Oncology projects in clinical development.

The ideal candidate will lead the strategic development of documentation submitted to the US FDA and lead FDA meetings and negotiations. In this high-profile role, you will represent the US Global RA perspective as a member of the project specific cross functional global regulatory team. You will be accountable to develop and maintain the US regulatory strategy documents and advise on US regulatory issues at internal meetings. As well, this role prospectively works with the labeling strategist and the global team to develop US prescribing information.

This role will also work with and participate on multi-disciplinary matrixed project teams to successfully meet project deliverables while adhering to regulatory requirements for programs and products. This role participates in the development and monitoring of the US regulatory environment and updating of standards and processes related to drug and biologics US regulations. Bring your coaching and mentoring personality to train junior staff supporting the RA teams. The position may be based in Northern NJ, NYC or Boston  MA or remote, home based.

Lead the strategic development of briefing materials and prepare teams for US FDA meetings. Participate in the development of and assess the appropriateness of submission documentation to support successful US INDs/BLAs/NDAs. Represent company at US FDA for assigned projects.

Requirements: At least 10-15 years’ regulatory experience in pharmaceutical drug development. Solid working knowledge of drug development process and US regulatory requirements. Demonstrated experience developing and implementing regulatory strategies for US INDs, BLA, and/or NDAs. Experience with rare disease drug development is an asset. Demonstrated experience successfully operating in a global environment. Advanced scientific degree preferred. B.A./B.S. or higher degree (s) in the sciences, or health related field minimum, with 10 years regulatory experience. Solid knowledge and understanding of complex medical and scientific subject matter as well as evolving US regulatory policy and guidance. Direct interaction/negotiation experience with US FDA.

Salary: Higher than average, full and thorough compensation package!

Location: New Jersey, MA, USA or Remote (home based).

Call Cris Murray 416 225-6386, VP Recruitment, J. Edgar and Associates Inc., to apply for this exciting career opportunity.

Please send your CV to me directly for consideration: jedgar@sympatico.ca in either a word or PDF format. Once you submit your CV, I will personally call you back to discuss and disclose our clients details so that you can determine your interest level.


 OPTICAL DEVICES MANUFACTURING ENGINEER - BAY AREA - CALIFORNIA - ABOVE MARKET$

We are currently seeking an experienced Engineer for the manufacturing and production of optical/optics technology components including:  fabrication of parts, components, subassemblies and final assemblies  from developing, implementing and maintaining methods to operation sequence and processes. This position will oversee manufacturing estimates/costs, determining time standards and making recommendations for tooling and process requirements of new or existing product lines.

It is crucial to have experience with formal Optical Manufacturing standards: MIL-PRF-13830 or ISO 10110, ISO 9001 and 13845 Standards as well as a strong Bachelor, Master or Doctorate level degree in Optics or Opto-Mechanical/ Electrical Engineering or applicable Physics and Engineering designations. You must be able to read and interpret mechanical design drawings, electrical schematics and be able to use CAD (Pro-E, ACAD,SWorks, MSProject, Access, SAP-ERP, Visio) tools like ZEMAX to perform modeling and to determine optical tolerance capabilities. This position requires the understanding of laser, optical filter and Photo-Multiplier Tube functions and direct diode lasers.

This position seeks to execute and refine build sequences specific to optics integration, laser optical alignment and system calibrations including evaluating build processes and manufacturing effectiveness for optimal build cycle times and product design specifications. This position will lead efforts in testing and qualifying optical components and modules. Any optics related issues or laser alignment improvements will be part of this mandate. You must be able to solve complex technical issues that require strong understanding of mechanical, optical, electrical and fluidic engineering principles.

We are looking for 7-10 years of Optical engineering experience preferably in Medical Device or Medical Tech with strong cGMP and 21CFR-820 familiarity, DFT Processes (Demand Flow Technology) experience, LEAN, Six Sigma or Black Belt capabilities.

Location: Bay Area, California

Salary: Above Market plus target bonus Plan

Call Jason Edgar at 416 225-2628 for all the details. Please send your CV directly to me for consideration: careers@jedgarcareers.com 


  SENIOR R+D PRODUCT DEVELOPMENT ENGINEER MANAGER-MEDICAL DEVICES-REMOTE AND ONSITE SPLIT WORK WEEK-BAY AREA, CALIFORNIA

We are currently seeking an experienced R+D Engineer with hands on project management experience leading cross-functional teams in product redesign and new product development. This high-profile position is responsible for ensuring the timely development and successful completion of the New Product Introduction sustainability projects portfolio.

The ideal candidate will contribute to improving product development process effectiveness and best portfolio management processes: must have a combination of program and project management including new product development within an R+D setting, preferably in the Medical Device sector with FDA experience or other related Regulatory environment experience.

This role will lead a team of 3 direct reports (remote and onsite) and train the product development teams on Global Product Development System and Process including execution. Will be able to perform skill gap assessment, formulate strategy to address gaps; perform PM training (PMP Certificate preferred) and mentor team. Write meeting minutes and communicate meeting outcomes to relevant stakeholders. Maintain SharePoint sites used by portfolio management team and team leaders. Lead small to medium cross-functional strategic initiatives. Ability to work with business and corporate units with ease.

In this exciting high-profile role, your goal will be to lead and Maintain Visual Management System, KPI’s, track program progress and hold project teams accountable, and publish clear business priorities. This position is designed to attract top talent, offer a platform for high potential associates to gain broad and far-reaching cross-functional business experience and to prepare them for future leadership roles.

Must have 7-10 years of hands-on experience working in R+D and/or Engineering project management leadership teams. Experience OR Knowledge of Flow Cytometry, Sorters and Cell Analyzers will be considered a huge asset.

Education: Bachelor’s degree in Science/Engineering disciplines preferred. PMP Certification preferred.

Salary: Commensurate with experience and higher than average.  15% Bonus and full Health benefits included.

Call Cris Murray 416 225-6386, VP Recruitment, J. Edgar and Associates Inc., to apply for this exciting career opportunity.

Please send your CV to me directly for consideration: jedgar@sympatico.ca in either a word or PDF format. Once you submit your CV, I will personally call you back to discuss and disclose our clients details so that you can determine your interest level.


SENIOR SCIENTIST - IVD REAGENT AND ASSAY DEVELOPMENT - CALIFORNIA

We are currently seeking an experienced IVD ASSAY Development Scientist to join a team of successful Biosciences experts in the pursuit of new Reagent systems. This is a new product R+D role that will act as a Senior resource on the team.

Within this R+D group you will be responsible for initiating and driving reagent and assay development projects and integrating assays and flow cytometry instruments to create the next generation of research and clinical flow platforms; these products include Cell Analyzers, Cell Sorters, Reagents, Assays and their applicable software. Your ability to work with cross functional teams in Engineering and Regulatory Affairs and others, is critical to the mission.

We are looking for a Senior Scientist who maintains a strong understanding of state-of-the-art science and technology development in industry in order to provide leadership and expertise to programs and projects in assigned business areas. This position requires an expert in the design and execution of experiments using applied biological sciences that further the development, verification and evidence generation efforts across assigned projects. Your ability to develop benchmarking studies with competitor assays in order to find improvement opportunities is important.

You must have strong experiences in Immunology in order to develop next generation Cancer screening reagents for the evolution of Flow Cytometry. The goal is to develop assays for specific Leukemia and Lymphoma target diagnostics (IVDs); experience in targeting L+L is important in this role. As SS, you will participate in clinical development programs for the effective introduction of new products, consistent with the strategic R+D plan.

You must have a Master Degree in Immunology with 5 years of Industry experience/Ph.D. +3 Years and possess experience in IVD product development, strong knowledge of processes and measures in R+D including any phase gated development systems, experience in the development of clinical Flow Cytometry assays and instrumentation and knowledge of biostatistical methods and data analysis using current tools(FacsDiva FlowJo Minitab JMP R). This is a 100% R+D Lab based role.

Salary - Above Market - Bonus - 10-15% - Location - San Francisco Bay Area, CALIFORNIA 

Call Jason Edgar at 416 225-2628 for all the details. Please send your CV directly to me for consideration: careers@jedgarcareers.com 


SENIOR SCIENTIST - METHOD DEVELOPMENT, PEPTIDE SYNTHYSIS, SMALL MOLECULE, NEW R&D -WEST COAST USA

We are currently working with a company with a long history of successful Scientific discoveries based on human healthcare needs. This company enables new product Research and Development by teaming great minds and the latest development tools to a specific mission of discovery. This thoroughly inclusive model has allowed the company to build a very strong product portfolio of Medical Devices, Pharmaceutical products and cutting edge Testing and Diagnostic technology.

We are currently seeking a small molecule and peptide synthesis capable Scientist to join a high performance team  on a mission to develop fluorescence dyes for use in Flow Cytometry and other biological applications. Experience with small molecule and macromolecular or polymer separations, purifications and characterizations is key in creating dyes from early proof of concept to formal product development.

Responsibilities: Identify potential new technologies for separation and analytics of fluorescence-based materials. Develop analytical methods from initial feasibility through assessing robustness and capability against desired or current specifications. Design and execute on measurement system analysis (MSA) and Gage R&R studies. Assist with development strategy by interpreting data and providing guidance to product development team being able to speak as a subject matter expert to separation and analytical techniques. Work collaboratively in small teams with chemists, biochemists and applications scientists to establish dye specifications through data driven recommendation. Work within early product pipelines, contributing to various stages of development from early proof-of-concept to process development. Build case for setting dye specifications through statistical processes and data analysis. Perform and oversee a wide variety of small-molecule and macromolecular processing, purification and characterization steps.Draft SOPs, technical reports, and presentations for communicating project progress.

Qualifications: Master Degree with at least 5 years of organic or materials chemistry experience or Ph.D with 1-3 years of industry experience in related field.  Strong diagnostic and analytical skills, experience with HPLC/SEC/IEX chromatography.Experience with UV/Vis and fluorescence spectroscopy. Experience with Six Sigma, MiniTab, or statistical analysis. Efficient with experimental design including statistical approaches such as Design of Experiment (DoE) approach. Some experience with organic synthesis/bioconjugation/materials science is desired. Good organizational and project planning skills. Strong technical writing and team presentation skills to convey findings in order to fulfil formal product design and development.         

Location - US West Coast - Southern California region, Salary - Above market compensation with Bonus plan, 401K plan and thorough health benefits plan.

Relocation - Assistance is provided if required.

Call Jason Edgar at 416 225-2628 for all the details. Please send your CV directly to me for consideration: careers@jedgarcareers.com 


TEAM LEAD - NEXT GEN ANTIBODY REAGENTS - NEW PRODUCT R+D - US WEST COAST

We are currently supporting a global leader with a long history of successful Scientific discoveries based on human healthcare needs. This company enables new product Research and Development by teaming great minds and the latest development tools to a specific mission of discovery. This thoroughly inclusive model has allowed the company to build a very strong product portfolio.

We are currently seeking a Senior Scientist to lead a Team in the development of next generation Antibody Reagents and R+D line extension product development. The company has strong success in Reagent development to date and through this high performance Life Sciences R+D team, they will enhance existing products and build on that development to develop new Reagents.

Responsibilities: Lead a team to assess feasibility and viability of new antibody reagents. Serves as a resource to team level scientists to guide experimental design and analysis of Flow Cytometry experiments. The Team Lead will contribute to the completion of milestones associated with specific projects. As part of the process improvement group in new product R+D, transitioning assays from manual to automated workflows is a goal. As part of the planning and project management leadership team, you will participate in functional and cross-functional training to advance technical capabilities of the New Product development team. This position requires the ability to critically analyze and interpret data and provide feedback and guidance to team members. As Supervisor, you must be proficient in promoting a safe and compliant work environment.

Qualifications and Skills: Master Degree in Immunology or a life science discipline with 6 years’ experience developing antibody reagents and operating a flow cytometer OR Ph.D with 4 years of combined industry and academic experience in flow cytometry component of antibody reagent development. Minimum of 4-6 years’ experience designing, performing, and analyzing flow cytometry experiments, preferably on X20, FACSymphony, Lyric, Canto and Aria flow cytometers. Workflow automation and Process Improvement experience is a strong asset for this role.

Strong understanding of flow cytometry principles and instrumentation and optimizing flow cytometer settings is preferred as well as solid experience with Flow Cytometry Data analysis tools. Strong general Laboratory skills and strong knowledge of immunology are required in this role. Excellent oral and written communication skills as well as a history of project management experience and strong analytical problem-solving skills is required in this role. This position requires an organized self starter with demonstrated organizational, time management, and planning skills to efficiently prioritize and manage multiple projects.

Location - US West Coast - Southern California region

Salary - Above market compensation with Bonus plan, 401K plan and thorough health benefits plan.

Call Jason Edgar at 416 225-2628 for all the details. Please send your CV directly to me for consideration: careers@jedgarcareers.com


   Manufacturing | Technology | Finance | Clinical Research | Shanghai Careers Resume |