Job Title: Manager, QC Biochemistry

Work Location: Mercer County, New Jersey

Summary:

Supervises staff and executes QC Biochemistry laboratory activities to support GMP manufacturing, testing and release of material, intermediates and finished products under FDA/EU regulations and applicable International Regulations. Establishes and implements QC Biochemistry procedures and supports regulatory compliance inspections. Ensures efficient and effective day to day operations of the Biochemistry laboratory.

Responsibilities:

• Lead the QC Biochemistry GMP laboratory through late phase activities.
• Oversee QC Biochemistry laboratory related quality systems to ensure conformance with regulations and global quality standards.
• Supervise a highly efficient QC Biochemistry team. Identify and develop key talents.
• Manage QC Biochemistry laboratory routine operations, including but not limited to validation, SOP revisions, specification updates, testing records, personnel training and scheduling, etc.
• Execute laboratory bench work for analytical methods such as Potency assays, Binding ELISA, Cell Culture, Residual Host Cell Protein (HCP), Residual DNA as required.
• Ensure Biochemistry laboratory compliance with Environmental Health and Safety (EHS) standards.
• Ensure timely completion of testing (e.g., in-process, DS release, DP release, and stability testing) to ensure timely generation and reporting of test results in support of manufacturing operations.
• Ensure appropriate investigation of OOS events, discrepancies, lab errors, and equipment failures.
• Implementation of effective corrective actions and preventive actions (CAPAs).
• Participate in internal and external GMP audits where possible.
• Manage QC Biochemistry method transfers and method validation activities, including transfer/validation strategy and approval of protocols and reports.
• Ensure that the QC Biochemistry laboratory meets or improves on budget, cost, volume, and efficiency targets (KPIs) in line with business objectives.
• Manage, motivate, coach and mentor direct reports.
• Undertake any other duties as required.

Qualifications:

• Scientific degree (ideally in Biochemistry, molecular biology, biotechnology or related).
• Minimum of 5-7 years working experience and 2 years managing laboratory analysts in an FDA-regulated biotechnology or pharmaceutical environment with progressive levels of responsibility.
• Working knowledge and experience with Biochemistry analytical methods such as Potency assays, Binding ELISA, Cell Culture, Residual Host Cell Protein (HCP), Residual DNA as well as instruments such as Incubators, Biosafety Cabinets, Plate Washers, and Microplate Readers.
• Knowledgeable with USP/EP and cGMP/EU GMP regulations.
• Direct experience in a GMP quality control lab is a must.
• Familiar with instrument and equipment validation.
• Expert knowledge of quality control principles, practices, and standards for the biopharmaceutical industry.
• Impressive, demonstrable track record and skills/experience gained within a similar position(s), at a similar level.
• Credible and confident communicator (written and verbal) at all levels.
• Strong analytical and problem-solving ability.
• Excellent project management skills.
• Hands-on approach, with a ‘can do’ attitude.
• Ability to prioritize, demonstrating good time management skills.
• Excellent attention to detail, with the ability to work accurately in a busy and demanding environment.
• Self-motivated, with the ability to work proactively using own initiative.
• Committed to learning and development.

Supervisory Responsibilities:

• Supervise a highly efficient QC Biochemistry team. Identify and develop key talents.
• Manage QC Biochemistry laboratory routine operations, including but not limited to validation, SOP revisions, specification updates, testing records, personnel training and scheduling, etc.
• Manage QC Biochemistry method transfers and method validation activities, including transfer/validation strategy and approval of protocols and reports.
• Ensure that the QC Biochemistry laboratory meets or improves on budget, cost, volume, and efficiency targets (KPIs) in line with business objectives.
• Manage, motivate, coach and mentor direct reports.

Published Category: Quality & Validation