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...Sr. Program Manager...Staff Engineer...Sr. Manufacturing Engineer...Manufacturing Project Manager...Principle Software Engineer...New Product Development...Director Regulatory Affairs...Director Clinical Development and Operations...Intermediate and Principal Stat Programmer...Optical Devices Manufacturing Engineer...Senior R+D Product Development Engineer Manager...Sr. Scientist...Sr. Scientist...Assoc. or Sr. Director Statistical Programming...Biostatistician...Senior Director...Director Sr. Director...Sr. Director and VP Level...Process Development Unit Head...Manager of Statistics...Team Lead...


  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


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