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...Regulatory Affairs Project Leader...Sr. QA Associate...Director Medical Affairs...Manufacturing Manager...Principal Scientist...Senior Clinical Development Leader...Principal Biostatistician/Statistician...Associate Director...Sr. Process Engineer...RNA Sr. Scientist...Data Scientist...Director...Sr. Manager Biostatistics...Sr. Manager...Director Engineering...


REGULATORY AFFAIRS PROJECT LEADER AT THE MANAGER OR DIRECTOR LEVEL: CANADA OR USA REMOTE BASED PAYING HIGHER THAN AVERAGE, PLUS BONUS , BENEFITS AND PENSION  

We are currently seeking an experienced Regulatory Affairs Project Leader at the Manager or Director level, with the ability to be the head of a newly created department. Initially, the position will have no direct reports, but the ideal candidate will be involved in creating the RA department and participate in interviewing and hiring 1-2 RA Associates as the business needs expand.

Functionality: This position functions as a leader in Regulatory Affairs and will require the individual to interface with clients to understand their clinical programs, assess their regulatory status, and recommend a solid plan forward to regulatory approvals and licensures as applicable. Establish and manage the Regulatory Affairs Department and eventually train and mentor a small team. In-depth knowledge and expertise in US FDA regulations and guidelines is required with the ability to draw upon your proven history of successful product approvals and experience with agency interactions to determine regulatory strategies and communications that will lead to approvals for drugs, biologics, and medical devices, is key. A thorough understanding of the approval process and the requirements to maintain compliance during the application process is required, with technical and operational expertise experience.

Daily duties: Actively participate in client meetings as a regulatory affairs Subject Matter Expert. Assess client programs and provide regulatory consultation, gap analysis and recommendations for regulatory strategies and solutions into the future. Provide pre-marketing and post-marketing advice, while adhering to compliance and applicable regulations. Plan submission strategies and health authority communications to develop successful product development plans to action through successful applications and submission life-cycle management. Act as the client’s US Agent with the FDA for applications to CDER and CBER and provide experienced knowledge of FDA submission requirements and technical expertise in submission dossier, planning, building, timing, and execution. Provide guidance for IND and NDA/BLA dossier lifecycle. Support bid responses and cost estimates for potential new regulatory projects and participate in bid defense meetings. Review existing SOPs and develop new SOPs.

Qualifications: M.Sc. Degree in health/Life Sciences, research field, Math, or any related discipline with 7-10 years of hands-on progressive experience. Successful track record of product approvals and key submission successes. Experience in preparing meeting packages (Pre-IND, EOP2, Pre-NDA). Proven knowledge of requirements for CDER applications of drugs and biologics. Health Canada, EMA, and any Regulatory Agency experience an asset. Experience with eCTD software an asset. Proven Leadership experience with retaining customers and winning new customers.

Location: CANADA OR USA (Remote), Salary: commensurate with experience, Benefits: thorough and comprehensive

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 QUALITY ASSURANCE ASSOCIATE - GMP/HEALTH CANADA - MONTREAL QC  - $90K PLUS BONUS BENEFITS AND MORE

We are currently seeking an experienced Quality Assurance Associate to join a growing team in Montreal. Your strengths in GMP compliance understanding and working with Health Canada to deliver Site licenses, GMP Documentation and SOPs following regulatory agency compliance are the main functions of this role.

As Senior Quality Assurance Associate, here are the tasks that you will be called upon to fulfil;

Ensuring the lot release of narcotics, pharmaceutical, medical devices and natural health products to the Canadian market. Overseeing and handling marketed product complaints, in collaboration with corporate partners. Overseeing and handling non-conformances received for marketed products, in collaboration with corporate partners. Reviewing the manufacturing changes made to marketed products. Reviewing APQRs (Annual Product Quality Reviews) for all marketed products. Spearheading product launch QA activities to ensure successful market launch. Participating in on-site Health Canada GMP audits and, as required, conducting inspections of suppliers involved in the manufacturing and/or distribution of pharmaceutical and natural health products. Lead maintenance and improvement internal processes for the development of the Quality Assurance department in collaboration with the Scientific Affairs department, as required. Perform other projects/tasks assigned to provide general support to the Quality Assurance Department. Overseeing and corresponding directly with Health Canada to ensure Site licences and internal QMS processes are compliant. Management of GMP documentation related to Site Licence for marketed products according to deadlines.

We are looking for a Quality Assurance Specialist with strong integrity to understand the goals of the QA team and develop strategic, hands on, compliant deliverables that follow Health Canada guidelines. You must possess excellent communication skills and fine attention to detail. The company offers a balanced and positive work environment in Montreal's downtown core.

 Location: Montreal, QC, Salary: $80K plus 10% Bonus plan, Benefits, RRSP Plan and more.

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 - MEDICAL AFFAIRS - DIABETES - CARDIOVASCULAR - GREATER TORONTO AREA - STRONG FIRM!

We are currently seeking a Medical Doctor to lead a Medical Business Unit consisting of Diabetes and Cardiovascular therapeutic areas.

Responsibilities: Builds and supervises the execution of medical strategic plans and oversees the implementation of medical affairs activities in Canada. Leads the development & oversees execution of Global Business Unit (BU) product and life cycle medical strategy at the Country level. Articulates the medical value of the BU. Leads the transformation of medical organization in alignment with evolving business model. Leads the medical team, promotes and ensures talents development, anticipates and builds required competencies and skills. Drives the medical affairs activities for prelaunch, launch and post-launch products ; ensures optimal life cycle management for all products in partnership with Research, Clinical Development, Commercial, Health Economics, Value and Access and Product Management functions.

Evolves organizations to align with strategy in the current and forthcoming digital environment (disruptive - digital), ensuring adequate resources assignment, cost control and manages performance of function. Builds external partnerships with health care partners, scientific organizations and patient advocacy groups. Ensures governance & compliance rules and risk management plans are implemented in accordance with organizational requirements and local regulation. Provides scientific and medical intelligence on the business landscape to anticipate key trends. Leads country evidence data generation strategy, plan and execution. Ensure scientific data dissemination is appropriate, timely and in line with company as well as country legal, regulatory and ethical norms. Act as final medical signatory for materials, both promotional and non-promotional and ensure that all internal Company standards and external industry codes are followed.

Qualifications and Experience: Medical degree (MD), Scientific/health related degree is acceptable if supported by significant experience in key therapeutic areas (Diabetes, Cardiovascular). 10 years (Min) Pharma Industry experience in medical affairs. Ability and track record of leading, managing and developing teams. Track record of change management in digital (disruptive) environment. Excellent knowledge of the Canadian Heath System and Market. Preferred knowledge of specific products and related therapeutic areas, including key opinion leaders. Strong KOL management. Ability to translate strategy into operational excellence. Ability to work across diverse functional teams and in alliance. Detailed knowledge of Regulatory guidelines, Medicines Act and the Human Medicines Regulations, Industry Codes of Practice and experience of their implementation within the business environment. Principles and practice of medical affairs including clinical trial design, management, analysis and reporting, including GCP. Experience of setting, balancing, and managing a budget to target. Experience in working in multicultural environment. Analytic and synthetic capacity. Leadership, teamwork, flexibility, rigor, open mind, respect for others, ability to listen to customer needs. Project focused, results oriented. Excellent communication and presentation skills with the ability to present scientific data in a credible manner. French an asset.

Location: Greater Toronto Area

Salary: ABOVE MARKET SALARY + 20% Bonus + Strong RRSP Plan and 5 Weeks Vacation

Benefits: Thorough and Generous, $15k CAR ALLOWANCE.

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. 


MANUFACTURING MANAGER - CELL AND GENE THERAPY - BOSTON, MA - VERY STRONG SALARY AND PACKAGE - GREAT FIRM!

We are currently seeking an experienced Manufacturing Manager for a leading gene and cell therapy manufacturing division producing recombinant AAV vectors, lentiviral vectors, and cell therapy products. This new position is calling on GMP manufacturing expertise to serve as Manager of Clinical Cell Therapy  Manufacturing. 

The ideal candidate will have expertise in cell therapy manufacturing with a demonstrated track record of successful development-to-clinical product transitions.  Creativity, scientific thoroughness, entrepreneurial mindset, and ability to function in a complex environment are essential.

Responsibilities:  Enable the manufacturing of cell therapy products for clinical supply, as a cell therapy technical expert for cGMP manufacturing, through providing hands-on technical leadership and operational oversight for a cell therapy manufacturing suite.

Provide leadership to oversee the operation of a GMP cell therapy manufacturing operations team. Manage operational staff, including developing staff capabilities through initial and ongoing training and maintaining team compliance. Provide management oversight of tech transfer activities. Provide management oversight of drug products production. Manage the production schedule and the daily tasks of the Manufacturing Operators. Provide oversight and guidance related to training materials, SOPs, batch records, reports, risk assessments, materials management, etc. Work cross-functionally with process development, quality, and other counterparts for the development of next-generation cGMP cell therapy manufacturing processes. Works closely with senior management to initiate new projects and assist in developing processes/techniques to meet business objectives.

Qualifications: Bachelor’s degree in sciences or engineering discipline with a minimum of 7 years of industry experience or a Master’s degree with a minimum of 5 years of industry experience. 2 years in managing direct reports or project teams. 2 years of experience in cell therapy. Experience in GMP documentation and compliance. Ability to operate and thrive in a fast-paced, high-growth environment. Strong skills in change management. Excellent communication skills.

Location - Boston area, MA - Salary - Strong above market salary with Bonus plan and 401K plan - Full Health Benefits, company incentives and more 

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


PRINCIPAL SCIENTIST ANALYTICAL DEVELOPMENT  - EARLY DEVELOPMENT CMC - BOSTON, MA  - GREAT PACKAGE WITH BONUS, 401K AND MORE.

We are currently seeking an experienced Analytical Development Scientist to provide CMC expertise to advance projects from late stage research through early development up to Phase 2 clinical trials as part of a global CMC division.

The Principal Scientist is responsible for Analytical methods development, analyses, characterization, chromatographic chiral and achiral separation and purification and stability studies of research and development compounds with handover initially to CMOs for early phase development activities followed by the transfer of analytical activities for U.S projects internally within the company and in Europe as appropriate for the late development of small synthetic pharmaceutical molecules.

Responsibilities: Collaborate with Formulation Development, Biopharmacy, Synthesis Development, Medicinal Chemistry and Process Chemistry and Process Engineering groups to support pre-development and early development activities up to Phase 2 clinical trials when projects transition to late development.

Develop analytical methods for the analysis of chiral and achiral molecules using HPLC, GC and LCMS, conduct analytical testing and stability studies of research compounds to support formulation, synthesis development in Early Development. Develop and implement platform analytical methods to support process chemistry and process engineering and provide local analytical support as needed. Oversee the chiral and achiral chromatographic separation and purification of research compounds with medicinal chemistry.

Supervise a small group of analytical scientists involved with the chromatographic purification, analyses and characterization and stability of research compounds and early development drug candidates. Responsible for the proper maintenance and operation of the analytical equipment in the laboratories including HPLC, GC, LCMS and Preparative Chromatography systems. 

Handover analytical methods to CMOs in preparation of Early Development activities to support GLP tox studies and early clinical trials. Responsible for oversight of analytical work performed at CMOs. Assist with the transfer of analytical methods from our CMOs to the late development CMC group as appropriate. Conduct the evaluation of the performance of the analytical team. Review analytical protocols and reports (validation and stability). Review analytical data for cGMP release and stability testing.  

Qualifications: PhD in Pharmaceutical Analytical Chemistry or related sciences, with a minimum  6- 8 years of experience within the pharmaceutical/biotech industry. Experience managing a small group of direct reports or teams. Expertise with the chromatographic separation of chiral and achiral molecules for the development and validation of analytical methods needed for the analysis and stability studies of compounds in pre-development and early CMC development. Expertise with the study and identification of chemical process impurities and degradation products. Working knowledge and experience of pharmaceuticals in pre-development and early development in preparation for IND/IMPD Dossier creation. Computer literacy with proficiency in Microsoft Office software, electronic notebook documentation and LIMS. Experience in preparing analytical reports as source documents for pre-development and early development. Excellent communication abilities along with experience with good documentation practices. Experience working with cross-functional teams.

Location - Boston, MA - Salary - Above Market plus Bonus and 401k - Full and Comprehensive health benefits

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


SENIOR CLINICAL DEVELOPMENT LEADER/ SCIENTIST - GLOBAL DEVICE LEADER - STRONG ABOVE MARKET COMPENSATION - 100% REMOTE WORK.

We are currently seeking an experienced Clinical Development Scientist to contribute to the strategic guidance of clinical and economic evidence related to the End to End development process from ideation through post-market commercialization for cardiac rhythm management medical devices.

You will collaborate with key internal and external stakeholders to provide in depth expertise to develop and lead clinical initiatives through non clinical and clinical strategies for new product development initiatives and product life cycle management. As the Clinical leader, you will drive clinical programs ensuring quality and timelines of Regulatory requirements with agility and responsiveness during the course of Trial design, completion and interpretation of trial data.

You will take part in collaboration with Investigators, Regulatory Agencies, societies and associations to support market access, claims and reimbursement strategies. This role will participate in clinical evaluation documentation including guidance on PMCF initiatives and clinical investigation documents, CSRs, CERs, abstracts and peer reviewed manuscripts. This position will be a member of the Clinical and Medical Affairs group with a strong focus on patient safety and customer needs.

Requirements: A medical or scientific education with MD, PhD. A demonstrated working knowledge of GCP, FDA regulations and EU-MDR regulations. In-depth understanding of product development and associated design controls for medical devices, 6+ years of experience in a similar role in the Medical Device or Pharma industry. An advanced degree will substitute for 2 years of experience, Self-directed with a strong work ethic, agile, and an ability to work in a goal-oriented environment.  Ability to collaborate effectively and influence decision making with various teams, cross-functional team members as well as external partners. Strong writing skills to produce quality clinical documents, including final reports.  Analytical thinking, able to present statistical methods and results to a variety of audiences, especially non-statisticians.  Ability to travel, including international (25% travel, or more at times).

Location: 100% Remote in the USA

Salary: Above market with Bonus and 401K Plan. Robust Health Benefits are included.

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


PRINCIPAL BIOSTATISTICIAN/STATISTICIAN - MEDICAL DEVICES - LEADING TECHNOLOGY - REMOTE USA -

This is an exciting opportunity for a Statistician or Biostatistician to work with a world leading Medical Device innovator currently in development of a new technology that will change health outcomes and ensure longevity in a leading disease category.

We are currently seeking an experienced Statistician to deliver clinical project activities by providing efficient clinical trial design and sample size through Clinical Study Synopsis and the Clinical Investigation Plan (CIP). This will include the development of simulation programs to assess trial operating characteristics as they are required.

Responsibilities:   Development and input of effective data collection and derivation strategies. Thorough randomization plan and list. Accurate, clear, and thorough statistical analysis plan (SAP)development  with the most appropriate methodology and data presentation. Support blind data review process and un-blinding process. Provide programming instructions to statistical programmers and check and approve statistical programming deliverables. Communicate, discuss, and interpret (top line) data and statistical results, including co-development of the clinical study report (CSR). Appropriate management and surveillance of external suppliers for outsourced statistical services. Collaborate with Manufacturing on process improvements including statistical process control (SPC) and statistical quality control (SQC). Develop and validate statistical models and simulations AND provide ad hoc statistical support for R&D to aid new product development. Perform design of experiments (DOE) to identify optimal parameter settings. Contribute to the development of protocols for test method validation, process validation, and design V&V activities with a focus on sample size justification and data analysis. Write reports which describe and interpret the experimental design of studies, methods of data analysis, and relevant results. Develop and implement procedures and best practice documents to standardize valid statistical approaches for common business needs. Provide basic statistical training to small groups of engineers and scientists during project work. Review new statistical methods for application to existing processes. Ensure that all activities under responsibility are properly documented (traceability of changes, data specifications, analysis validation) according to internal procedures. Contribute to project management plans and ensure that deadlines are met. Develop, apply and maintain computer programs for data analysis, e.g., SAS and R. Lead and participate in process and infrastructure projects while acting as an internal subject matter expert related to statistical activities. Encourage and maintain quality in all activities and follow the internal quality system. Collaborate effectively with Statistics & Data Management internal and external partners in all activities where statistics is needed. Communicate routine and complex statistical concepts and results to non-statistical internal and external colleagues in a clear, concise, and articulate manner.  Apply personal experience, research, input from colleagues, and critical thinking to challenge data analysis results originating from other individuals or yourself.

Requirements: We are looking for a self starter with the ability to provide statistical expertise to a technical group of innovators seeking to commercialize a major medical device development. You must be able to scale up and scale down workloads based on project needs. Experience leading cross-functional teams to reach required objectives is important in this role. As Principal Statistician, you will be recognized as an expert throughout the organization in multiple areas. Your ability to implement  improvements both in statistics and other areas of the company including developing processes will be beneficial in this role.

We are seeking demonstrable advanced experiences in clinical development in the pharmaceutical, CRO, or medical device industry, in the development and implementation of advanced methods such as adaptive design, Bayesian statistics, and missing data analysis. Basic knowledge of CDISC, SDTM and ADaM. Strong skills in statistical software such as SAS, R. Master degree in Statistics/Biostatistics with 14 combined years of experience in a life science industry in clinical or product development either in pharmaceutical, medical device or CRO.12 years of relevant experience with Ph.D.

Location - Remote USA, Salary and Bonus - Strong and Competitive plus 401K plan, Vacation - 3 weeks, Benefits - Thorough and robust

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

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


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. 


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.


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