Lab Production Specialist

Cs Genetics Limited - San Diego, CA

Full-time

San Diego, CA

About the position

The Lab Production Specialist at CS Genetics will collaborate with R&D, Supply Chain, and Engineering to define and enhance manufacturing processes for a new single-cell genomics product line. This role involves understanding R&D processes, executing pilot builds, and improving manufacturing quality and cost. The specialist will also conduct root cause analysis for any issues and implement corrective actions, ensuring product quality and adherence to good manufacturing practices.

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 nonconformances and deviations, including gathering information through structured root cause analysis.
• Draft and revise deviation reports to ensure timely addressing of deviations.
• Support activities to ensure operational readiness for manufacturing, including equipment procurement and facility qualification.
• Write, gather input, and maintain Standard Operating Procedures (SOPs), Batch Records, Recipes, Bill of Materials (BOM), Routings, and Specs for manufacturing.
• Manage change control associated with manufacturing areas and equipment.
• Seek and support new approaches to improve manufacturing efficiency and quality.
• Provide updates on build progress, issues, trends, and solutions to leadership.
• Collaborate with R&D and Engineering to develop and characterize reagent formulation, filling, and kitting processes.
• Participate in label, kit, and packaging designs.
• Analyze and trend process and performance data to support pilot or engineering builds.

Requirements

• Minimum of three (3) years of experience with a BS in a relevant science or engineering discipline.
• 2+ years of hands-on experience in laboratory production environments using basic equipment such as pipettes and centrifuges.
• Demonstrated knowledge of industry best practices in reagent manufacturing operations in Life Science, Biotech, or Pharma.
• Ability to build relationships quickly and provide excellent support to cross-functional team members.
• Proactive, results-oriented self-starter with strong leadership skills in a complex manufacturing environment.
• Ability to manage constant change and work successfully in a fast-paced, team-oriented environment.
• Quality mindset, familiar with ISO, Lean, Six Sigma, and 6S.
• Excellent presentation, communication, and problem-solving skills with great attention to detail.
• Familiarity with data and systems (LIMS/MES/ERP/PLM).

Benefits

• 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