Supervisor, Process Development and QC - job 1 of 2

Position Summary

This is an exciting position for someone looking to develop and guide a team. The Quality Control Supervisor will play a key role in Design Transfer from R&D to Operations for all reagent related activities and be responsible for leading all associated acceptance testing activities.

This position is full time 100% in person and reports to the Director, Assay Development.

Specific responsibilities include, but are not limited to:

• Lead process development of reagents in IVD product
• Perform guardbanding studies to help set manufacturing and QC specifications
• Create reagent manufacturing and reagent QC work instructions and batch records as part of design transfer
• Responsible for reagent and IVD product Test Method Validation
• Develop, mentor and supervise a process development and QC team
• Perform analytical and functional QC testing according to work instructions and batch records
• Work with QA to develop a process to release reagents to production inventory
• Ensure traceability of reagents by following the company’s established procedures for lot number assignment and recordkeeping
• Establish training plan for team members to ensure all personnel are trained to adequately perform their assigned responsibilities
• Maintain regulatory compliance to applicable federal, state, and local regulations
• Monitor Quality Control metrics for trend analysis
• Adhere to the Talis quality control program
• Responsible for documenting QC instrument checks and procedural calibrations and maintenance in compliance with cGLPs and cGMPs
• Identify problems that may adversely affect test performance and communicate to the cross-functional team
• Work closely with assay development, systems Integration, quality, supply chain and cartridge manufacture to solve technical issues
• Utilize job knowledge, judgment, and problem-solving skills to ensure that high quality material is released

Education/Skills/Requirements

• Bachelor's degree in Molecular Biology, Biochemistry, Chemistry, or an associated relevant field or equivalent. Master’s degree preferred.
• 5+ years of experience in reagent manufacturing for IVD product
• Prior experience with design transfer and manufacturing and QC scale-up
• The candidate must be a team player who is self-driven, motivated, organized, analytical, detailed, and flexible in a fast-paced environment
• Strong communicator with the ability to maintain open communication and collaboration with team members, management, and other departments
• Ability to prioritize and adapt to changing environments while maintaining a high standard of quality
• Experience with nucleic acid amplification technologies and/or RT-LAMP desirable

This role will be located in either Redwood City, CA or Chicago, IL. If in CA, the expected compensation range is $110k to $120k, dependent on experience.