Oversees the laboratory quality control testing of in-process, stability, and final drug products. Has technical responsibility for all bioanalytical aspects of QC testing.
- Coordinates with members of Manufacturing, Stability, and Business Ops to provide analytical support.
- Manages QC Analysts, distributes work load, and monitors progress.
- Manages product testing to ensure efficient and compliant operations.
- Reviews test reports.
- Ensures QC Analysts receive proper training.
- Attends meetings to keep informed of manufacturing priorities.
- Ensures that safety standards are maintained.
- Ensures compliance with applicable cGMP regulations and SOPs.
- Investigates atypical and OOS test results as necessary.
- Manage assay transfer internally from R&D to the QC laboratory or from PAS to the QC Laboratory.
- Manage assay transfer externally from QC laboratory to contract labs, includes audits if needed.
- Manages QC projects including analytical commitments for Regulatory filing, follow-up actions for general GMP inspections and its readiness.
- Track and coordinate major analytical investigation
- Track and monitor timeline of analytical validation projects.
- Monitor the team performance for Compliance events, track, assist and organize continuous improvement events.
- Interact with Regulatory Agencies as needed to ensure cGMP compliance.
- Special projects as assigned.
- Performs personnel management functions including time sheet submissions, scheduling of vacations, personnel development/feedback, and performance evaluations
Skills, Education and Experience:
- BS in chemistry, biology or related field with 7+ years’ relevant experience (pharmaceutical or biotechnology industry) in laboratory management and analytical sciences and 5+ years’ experience in a supervisory/leadership capacity.
- Thorough understanding of bioanalytical techniques in a cGMP environment.