Supervisor, Process Development and QC - job 2 of 2
About the Company
Our purpose at Talis Biomedical is to advance health equity and outcomes by delivering accurate infectious disease testing in the moment of need, at the point of care.
While timely diagnosis of infectious diseases is critically important to enable effective treatment, testing is primarily performed in centralized laboratories, which require samples to be shipped for processing, delaying the return of results by days. Point-of-care testing solves this problem by delivering the timely information necessary for clinical care.
To deliver our purpose we focus on three things:
- Putting customers and patients first
- Making Talis a great place to work
- Living our values to Dream Big, Share Our Screens, Serve Others, Bring Our "A" Game, and Build Trust
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.
Talis Biomedical offers a comprehensive health and well-being benefits programs, long-term equity incentives, time-off policies, a 401(k) retirement savings plan with an immediate Company match, Education Assistance Program, a rotating suite of snacks, Happy Hours, office perks, and other fun company events! Best of all, join us by working at a growing company like Talis with dedicated and collaborative employees committed to making a difference in Health Care.
Talis Biomedical is proud to be an equal opportunity workplace. All aspects of employment decisions will be based on merit, competence, performance, and business needs. We do not discriminate on the basis of any status protected under federal, state, or local law. We celebrate diversity and are committed to creating an inclusive environment for our colleagues. Talis Biomedical is an E-Verify Participation company.
More About Talis Biomedical:
Built on a foundation of world-class science and engineering, we are developing the Talis One platform, a sample-to-answer, cloud-enabled molecular diagnostic platform that could be rapidly deployed to distributed diagnostic settings in the United States and around the world to diagnose infectious disease at the point-of-care. The Talis One platform comprises a compact instrument, single-use test cartridge, and innovative software including a central cloud database. This system is designed to provide central laboratory levels of accuracy and be operated by an untrained user.
Talis has raised more than $500 million to date and went public in February 2021.
At Talis, we are dedicated to advancing health equity and outcomes through the delivery of highly accurate infectious disease testing in the moment of need, at the point of care.
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