Summary:Oversees the laboratory quality control testing of in-process, stability, and final drug products. Has technical responsibility for all bioanalytical aspects of QC testing.
Essential Duties and Responsibilities include, but are not limited to, the following:
• 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
Education and Experience:
• Requires BS/BA in Life Sciences or related field with 6+ years of relevant experience, preferably in the pharmaceutical or biotechnology industry. Previous supervisory/ leadership experience in a laboratory environment is required.