Lab Production Specialist
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Job Description
About CS Genetics
CS Genetics is a privately held genomics-technology company based in San Diego, California and Cambridge, UK. We are a nimble, highly capable team focused on delivering genuine step-change innovation in genomic tools for research and clinical applications. We have developed a disruptive platform for single-cell genomics which leverages instrument-free, solution-phase chemical biology to provide unmatched ease-of-use, scalability, and affordability.
Position Summary
The Lab Production Specialist will partner with R&D, Supply Chain and Engineering to define manufacturing processes and support technology transfer for a new, cutting-edge single-cell genomics product line. Responsibilities will include building an understanding of R&D processes to scale up and better characterize manufacturing for commercial use spanning formulation, filling, and kitting. This includes generating associated documentation, executing pilot builds for qualification and commercial builds for market entry. The role will also participate in efforts to improve the quality and cost of manufacturing. When issues occur, the individual will be responsible for conducting root cause analysis of failure modes and implementing corrective actions as necessary. The individual promotes product quality and optimization of cost of goods through proactive integration of process controls and good manufacturing practices into operations. This individual will work in a dynamic team-oriented environment helping CS Genetics deliver its highly sophisticated product pipeline to its customers.
Key Responsibilities
- Learn and understand the applicable production processes for new products and support technology transfers as the manufacturing subject matter expert.
- Perform and/or support investigation of minor, major and critical nonconformances and deviations, including gathering information through structured root cause analysis. Draft and revise deviation reports as needed to assure that deviations are addressed in a timely manner.
- Using general application of principles supports activities to ensure operational readiness for manufacturing of products including equipment procurement, installation and qualification, facility qualification and technology transfer.
- Performs tasks in a manner consistent with safety policies, quality systems, and product requirements introducing best practices in these areas from previous experience
- Write, gather input and maintain Standard Operating Procedures (SOPs), Batch Record, Recipes, Bill of Materials (BOM), Routings and Specs for manufacturing to accurately reflect current processes.
- Own and manage change control associated with manufacturing areas and equipment.
- Continuously seek and support new approaches, practices, and processes to improve the efficiency and quality of manufacturing
- May work on assignments that are moderately complex in nature, where judgment is required to resolve operational issues without negatively impacting manufacturing efforts.
- Provide verbal and written updates on build progress, issues, trends and solutions to problems to leadership.
- Collaborate with R&D and Engineering to develop and characterize reagent formulation, filling and kitting processes to support scaling based on commercial forecasts.
- Participate and contributes to label, kit and packaging designs.
- Analyze and trend process and performance data and when appropriate supports pilot or engineering builds to demonstrate improvements to the manufacturing processes
- Additional duties as required
Minimum Requirements/Qualifications
- Must have a minimum of three (3) years with a BS in relevant science or engineering discipline.
- 2+ years of hands-on experience in laboratory production environments usijng basic equipment such as pipettes, centrifuges, vortex and a general understanding of good lab practices (GLP)
- Demonstrated knowledge of industry best practices in reagent manufacturing operations in Life Science, Biotech or Pharma
- Ability to build relationships quickly and credibly. Provide consistent, excellent support to cross-functional team members, with the ability to influence teams outside the manufacturing department with a variety of personalities and experience levels.
- Proactive, results oriented, self-starter with demonstrated strong leadership skills and experience in a complex manufacturing environment.
- Ability to deal with ambiguity ready to change gears and plans quickly, with the need to manage constant change.
- Ability to work successfully in a fast-paced, team-oriented environment.
- Quality mindset, familiar with ISO, Lean, Six Sigma and 6S
- Excellent presentation, communication(writing/oral), commuter and problem-solving skills and a great attention to detail
- Familiar with data and systems (LIMS/MES/ERP/PLM)
- An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above.
What We Offer
- Exceptional team with a dynamic and interactive culture
- Opportunity to work side-by-side with key leadership to build operations capability from the ground up
- Regular company and community social activities
- Competitive compensation package including equity incentive program
- Visa sponsorship available for exceptional candidates
