QC Manager, Bioassay/Virology Specialist
2 weeks ago
The Manager, Bioassay/Virology is responsible for contributing to key functional, tactical, and operational aspects of the QC group at Fujifilm Diosynth Biotechnologies. This role is accountable for GMP compliant laboratory operations according to regulatory guidelines.
Key Responsibilities- Ensures GMP compliant laboratory operations according to GMP guidelines
- Manages the daily activities of the QC Bioassay & Virology team, prioritizing work and ensuring overall performance according to KPIs
- Assures timely analysis, review and approval of results in support of on time CoA issuance or stability time point
- Oversees and manages laboratory exceptions and investigations, ensuring timely closure within the group according to Quality metrics
- Leads projects, like method transfers and method qualifications in support of new product introduction for new and existing customers
- Prioritizes and focuses on optimized laboratory systems, including the use of IT systems, and identifies and implements needed procedural and/or policy changes
- Bachelor's degree with 8+ years of experience in a GMP environment OR Master's Degree with 6+ years of experience in GMP environment OR Ph.D. with 4+ years of experience in GMP environment
- Previous QC Bioassay and Virology leadership experience
- Advanced knowledge in Bioassay and Virology testing methods
- Ability to stand for prolonged periods of time up to 120 minutes
- Ability to sit for prolonged periods of time up to 240 minutes
- Ability to conduct activities using repetitive motions that include writs, hands and/or fingers
- Ability to conduct work that includes moving objects up to 33 pounds
- Ability to bend, push or pull, reach to retrieve materials from 18" to 60" in height and use twisting motions
- Ability to work in environments between -20 and -70 C for a few minutes with appropriate PPE
- Will work in heights greater than 4 feet
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