Senior Scientist, Product Support - Biomatrica
The Sr. Scientist, Product Support role will lead a variety of technical and scientific activities within Operations. This position will investigate issues through trending, troubleshooting, and root cause analysis, working closely with R&D, Quality, and Operations to design, develop, and implement corrective actions through use of the Quality Management System. This role will also have responsibility for supporting Operations teams in method development, new product introduction, product and process validations and continuous improvement efforts. This role may also provide direct leadership oversight for a role or small team.
Essential Duties and Responsibilities
- Provide technical and product support leadership in Operations working cross-functionally with the Production, QC, Supply Chain, R&D and Quality teams.
- Lead and support troubleshooting of Out of Specifications (OOS), non-conformances (NCMRs), customer complaints and corrective action preventive action (CAPA) plans through root cause investigation, experiment design, study execution, data analysis and reporting.
- Provide support to Operations teams for qualifying and validating new raw materials and alternative supply channels for products.
- Analyze, track, and trend historical Production and Quality Control data.
- Lead and support design of CAPA plans working closely with Quality Teams.
- Clearly and accurately generate experimental protocols, draft work instruction procedures, characterize and develop test methods and test method improvements, summarizing activities through technical or investigative reports.
- Program, operate, and troubleshoot complex instrumentation such as micro plate readers, real-time PCR instruments, and liquid handling automation.
- Oversee design and execution of complex studies and designed experiments. Provide thought leadership and mentorship.
- Strong business acumen and strategic agility driving innovative solutions and new ideas forward.
- Conduct bench level experiments within several product or technology areas to identify problems and discrepancies.
- Support Manufacturing and QC activities as needed, including formulating and testing product.
- Perform other related duties and special projects as assigned by management.
- Ability to effectively communicate with multi-level personnel as well as outside vendors and their representatives.
- Ability to influence others, deliver on team vision, and hold partners accountable to timelines.
- Ability to effectively work on several varied projects at one time, with frequent changing priorities.
- Effective analytical, problem solving and decision-making skills. Proven ability to work effectively in team situations as well as independently.
- Able to collaborate across functions and within a workgroup to meet business objectives.
- Proficient in a variety of common laboratory skills and techniques with a base knowledge in chemistry, biochemistry, molecular biology, or a related field.
- Excellent oral and written, communication, interpersonal, and presentation skills. Strong attention-to-detail.
- Ability to prioritize tasks and adhere to project schedules and timelines.
- Ability to thrive in a fast-paced, frequently changing, and evolving environment.
- Uphold company mission and values through accountability, innovation, integrity, quality, and teamwork.
- Support and comply with the company’s Quality Management System policies and procedures.
- Regular and reliable attendance.
- Ability to work designated schedule.
- Ability to work nights and/or weekends.
- Ability to lift up to 50 pounds for approximately 10 % of a typical working day.
- Ability to work standing for approximately 50 % of a typical working day.
- Ability to work on a mobile device, tablet, or in front of a computer screen and/or perform typing for approximately 90% of a typical working day.
- Ability to grasp with both hands; pinch with thumb and forefinger; turn with hand/arm; reach above shoulder height.
- Ability to comply with any applicable personal protective equipment requirements.
- Ability to travel 5 % of working time away from work location, may include overnight/weekend travel.
- Bachelor’s degree in Life Sciences, or related field.
- 7+ years of experience with medical device products in a development or product support role.
- 3+ years of hands on experience in molecular biology and biochemical techniques.
- Knowledge of statistical and mathematical methods in biology/genetics, including experience JMP software.
- Knowledge and experience working within FDA regulated 21 CFR 820 environment, ISO 13485 and/or cGMP structured environment.
- Understanding of IVD product manufacturing processes, biochemical, molecular & real-time-PCR Assays.
- Authorization to work in the United States without sponsorship.
- Demonstrated ability to perform the Essential Duties of the position with or without accommodation.
- Knowledge in Design for Six Sigma and Statistics.
- Knowledge in basic and advanced continuous improvement methodologies/principles such as LEAN Six Sigma and/or Practical Process Improvement (PPI).
- Experience with Project Management principles and practice.