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Bioassay Manager
2 months ago
Preferred Requirements:
- Previous QC Bioassay and Virology leadership experience in a GMP environment
The Manager, Bioassay/Virology is responsible for contributing to key functional, tactical, and operational aspects of the QC group at Fujifilm Diosynth Biotechnologies. The Manager, Bioassay/Virology is accountable for GMP compliant laboratory operations according to regulatory guidelines. This role is responsible for direct management and supervision of the Bioassay & Virology team performing ELISAs, Potency assays, residual DNA/Host Cell Protein/Protein A assays, qPCR assays and Adventitious Virus testing. The Manager, Bioassay/Virology is the technical subject matter expert (SME) with in‐depth knowledge of QC analytical methods including: ELISAs, potency assays, qPCR assays, residual DNA/Host Cell Protein/Protein A assay, Adventitious Virus testing. This role provides managerial support for troubleshooting of complex investigations and optimizing laboratory systems, ensure that the laboratory is maintained in a state of GMP compliance, all documentation is in accordance with GMP, and that all reported results are accurate. The Manager participates actively in leading the QC Bioassay/Virology team and managing day‐to‐day activities of team. The Manager represents QC Bioassay/Virology during customer and regulatory audits. The Manager is accountable for modeling leadership competencies and aid in the development of QC team members.
What You’ll Do
- Ensures GMP compliant laboratory operations according to GMP guidelines
- Manages the daily activities of the QC Bioassay & Virology together with the planners in the team, and assuring dedicated focus on release, stability and clinical testing, including prioritizing work
- Ensures overall performance of QC Bioassay & Virology according to KPIs ‐ assuring turn‐around‐times of all release, stability and clinical testing performed in the QC Bioassay & Virology department
- Assures timely analysis, review and approval of results in support of on time CoA issuance or stability time point
- Oversees and manage laboratory exceptions and investigations and assure timely closure within the group according to Quality metrics
- Motivates the group to perform as efficient as possible to reduce turn‐around‐times for release of commercial, stability and clinical products.
- Manages and prioritizes the preparation of procedures, protocols and associated reports for various deliveries.
- Leads projects, like method transfers and method qualifications in support of new product introduction for new and existing customers.
- Prioritize and focus on optimized laboratory systems, including the use of IT systems, e.g. Labware, identify and implement needed procedural and/or policy changes in areas where needed.
- Enforce established policies, processes and procedures and identifies areas where enhancements will improve daily work
- Leads a team responsible for executing analytical methods that require aseptic techniques including: viral infectivity assays, qPCR assays, cell‐based assays, and clean cell culture
- Manages, directs and monitors lab activities and team as needed
- Leads method verification, qualification, and validation activities and maintain lab equipment
- Authors, reviews, and approves SOPs, protocols, reports, change management reports, Trackwise deviations and investigations for the QC Bioassay/Virology team as needed
- Ensures department is ready for customer visits, audits and regulatory inspections
- Performs investigations, manages complex issues, barriers, and problems to support team success
- Approves data reports within the team and area of discipline/focus, including approval of results
- Supports management for activities related to compliance with policies
- Provides leadership and mentoring as needed to aide in the development of the team
- Provides technical leadership through effective project management, status tracking including analytical improvement projects and technical problem solving with independence
- Proactively identifies technical gaps and areas for improvement related to quality
- Represents QC Bioassay/Virology on cross‐functional Tech Transfer teams in support of implementing, transferring, and/or validating client methods ahead of new program campaigns
- Manages complex problem solving, providing mitigation/outcome to management/team. Decisions at this level include those that have potential compliance impact to methods, results, product, and/or Quality systems, decisions with impact to customers, or pertaining to personnel issues that must be handled with consultation and recommendations to management
- Performs other duties, as assigned
Minimum Requirements:
- 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
