The Senior Scientist, Transfer and Support will work cross-functionally to lead and coordinate a variety of technical transfer and product support activities within Operations. This role will lead the design, development, and implementation of new methods, processes, and procedures as part of the design transfer process including process characterization, and process validation activities. This role will also lead issue investigation through root cause analysis, implementing corrective actions, and continuous improvements.

• Lead people through the leadership of workstreams, project teams, or direct reports.
• Support and lead Corrective and Preventive Action (CAPA) plans.
• Lead risk analyses activities, such as Process Failure Mode and Effects Analysis (FMEA).
• Lead root cause analysis using recognized tools, such as Fault Tree Analysis or Fishbone Diagrams.
• Develop and characterize moderately complex manufacturing processes, including buffers or mixtures, on complex equipment (e.g., automation) at multiple scales.
• Lead teams completing measurement system and test method development studies.
• Design basic method variability studies and execute basic measurement system analysis; including specification setting.
• Design stability studies for raw materials, intermediates, and finished goods.
• Act as a lead resource and core team member for the Manufacturing Sciences, Tech Transfer, and Validation (MSTTV) team to interface and collaborate with cross site departments (Quality Assurance (QA), Research & Development, Regulatory Affairs, Supply Chain, Engineering, and the Clinical Lab) to achieve business results.
• Lead more complex projects across functional areas.
• Draft and review quality documents; including, but not limited to, work instructions, Standard Operating Procedures (SOPs), and raw material specifications.
• Draft protocols supporting validation and stability studies in accordance with internal procedures, current Good Manufacturing Practices (GMP), and other standards and guidelines.
• Generate experimental protocols, inspection, and test method procedures, and summarize development activities through technical summary reports.
• Support all types of validation; including facility, equipment, process, computer system, packaging, test method, validation readiness, generation of acceptance criteria, and execution.
• Generate, review, and provide strategic input on validation documentation.
• Write new and edit existing Quality System documents.
• Execute improvement opportunities for the Quality System.
• Collaborate with QA to mitigate product or process level risk.
• Generate and drive corrective action plans for more complex change orders, non-conformances, and other investigations.
• Determine timelines and consistently hit both short-term and long-term deliverables and commitments.
• Excellent strategic agility, business acumen, and vision.
• Ability to drive decisions to completion and building policies when gaps are identified.
• Ability to generate plans, identify risk, and communicate to stakeholders and leadership.
• Ability to influence others, deliver on team vision, and hold partners accountable to timelines.
• Self-motivated; ability to function both independently with minimal supervision as well as part of a team.
• Proactive and forward thinking to plan and shift directions based on priorities/need; capable of thinking creatively to deliver on expectations without jeopardizing business results.
• Adaptable to rapid changes in priorities, strong sense of urgency, and able to identify ways to work together to achieve results needed for all requests.
• Excellent verbal and written communication skills.
• Ability to organize, present, and convey complex problems or issues within and across other functions.
• Ability to influence and inspire individuals outside Operations and hold others accountable.
• Strong documentation skills and attention-to-detail necessary in a regulated product development and manufacturing 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 lift up to 30 pounds for approximately 2% of a typical working day.
• Ability to work seated for approximately 80% of a typical working day. Ability to work standing for approximately 20% 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 50% of a typical working day.
• Ability and means to travel between Redwood City campus locations.
• Ability to travel 5% of working time away from work location.

Minimum Qualifications

• Bachelor’s degree in Chemistry, Biochemistry, Molecular Biology, Engineering, or related field.
• 10+ years of experience in an industry laboratory setting.
• 8+ years of experience working with biochemical and molecular assays.
• 8+ years working on in vitro diagnostic (IVD) product development and manufacturing.
• 3+ years of technical leadership or mentorship experience.
• Proficient in a variety of basic, intermediate, and advanced laboratory skills and techniques.
• Demonstrated ability to assess data normality, control charting and data trending, hypothesis testing, assessing variation, basic linear regression, and model fitting.
• Demonstrated ability to apply advanced techniques, such as Design of Experiments (DOE), Measurement System Analysis (MSA), and Multivariate Analysis of Variance (ANOVA).
• Demonstrated ability to apply tools to support continuous process improvement, such as LEAN Six Sigma and/or Practical Process Improvement (PPI).
• Demonstrated ability to apply recognized project management (PM) and scheduling tools, such as MS Project.
• Proficient in Microsoft Office.
• Demonstrated ability to perform the Essential Duties of the position with or without accommodation.
• Authorization to work in the United States without sponsorship.

Preferred Qualifications

• 3+ years of direct leadership experience.
• Working knowledge of JMP or other statistical software tools.
• Working knowledge of Enterprise resource planning (ERP) systems and Bill of Materials (BOM) management.
• Working knowledge of tools such as Process Flow and Value Stream Diagrams, Pareto Analysis, Control Charts, or Define, Measure, Analyze, Improve and Control (DMAIC).

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We are an equal employment opportunity employer. All qualified applicants will receive consideration for employment without regard to age, color, creed, disability, gender identity, national origin, protected veteran status, race, religion, sex, sexual orientation, and any other status protected by applicable local, state or federal law. Applicable portions of the Company’s affirmative action program are available to any applicant or employee for inspection upon request.