Manager, QC Biochemistry, Hopewell Site

BeOne Medicines Ltd • Hopewell, VA

108d • $108,100 - $148,100

About The Position

BeOne continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer. The Manager, QC Biochemistry 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, applicable International Regulations, BeOne processes and procedures. This role establishes and implements QC Biochemistry procedures and supports regulatory compliance inspections, ensuring efficient and effective day-to-day operations of the Biochemistry laboratory.

Requirements

• 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, pharmaceutical company.
• Working knowledge and experience with Biochemistry analytical methods such as Binding ELISA, Cell Culture, Residual Host Cell Protein, Residual DNA.
• 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.
• Strong analytical and problem-solving ability.
• Excellent project management skills.
• Hands-on approach, with a ‘can do' attitude.
• 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.

Nice To Haves

• Master's degree in Chemistry, Biochemistry, or Biotechnology related scientific discipline.
• 4-5 years of working experience and 2 years managing laboratory analysts in an FDA-regulated biotechnology, pharmaceutical company.

Responsibilities

• Lead the QC Biochemistry GMP laboratory through late phase activities.
• Oversee QC Biochemistry laboratory related quality systems to ensure conformance with regulations and BeOne 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.
• Execute laboratory bench work as required.
• Ensure Biochemistry laboratory compliance with Environmental Health and Safety (EHS) standards.
• Ensure timely completion of testing to support manufacturing operations.
• Ensure appropriate investigation of OOS events, discrepancies, lab errors, and equipment failures.
• Implement 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.
• 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.

Benefits

• Medical, Dental, Vision insurance.
• 401(k) plan.
• Flexible Spending Account (FSA) / Health Savings Account (HSA).
• Life Insurance.
• Paid Time Off.
• Wellness programs.
• Employee Stock Purchase Plan.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager
• Industry: Chemical Manufacturing
• Education Level: Bachelor's degree