Manager, Quality Control Chemistry

BeiGene•Hopewell, VA

5d•Onsite

About The Position

Manages all Quality Control (QC) Chemistry Laboratory – Capillary Electrophoresis (CE) activities to support GMP manufacturing, testing and release of materials, intermediates, and finished products under FDA/EU regulations, applicable International Regulations, BeOne processes and procedures. Establishes and implements QC Chemistry procedures including but not limited to capillary electrophoresis and supports regulatory compliance inspections. Ensures efficient and effective day-to-day operations of the CE laboratory.

Requirements

Expertise in Quality Control (QC) within a Good Manufacturing Practice (GMP) environment, ensuring compliance with industry standards and regulations through hands-on laboratory experience.
Working knowledge and experience with capillary electrophoretic analytical methods such as reduced and non-reduced CGE, CZE, and cIEF/icIEF, etc.
Knowledgeable with USP/EP and cGMP/EU GMP regulations.
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.
Strong leadership/team management skills and experience.
Manage, motivate, coach and mentor direct reports.
Credible and confident communicator (written and verbal) at all levels.
Strong analytical, problem-solving ability, with excellent attention to detail, with the ability to work accurately in a busy and demanding environment.
Excellent project management skills.
Hands-on approach, with a ‘can do’ attitude.
Ability to prioritize, demonstrating good time management skills.
Self-motivated, with the ability to work proactively using own initiative.
Committed to learning and development.
2+ years of managerial experience directly managing people required.
Leadership experience leading teams, projects, programs or directing the allocation of resources.
Strong PC literacy required; MS Office skills (Outlook, Word, Excel, PowerPoint).
Ability to work on a computer for extended periods of time.
Bachelor’s Degree in Chemistry, Biochemistry, or Biotechnology related scientific discipline with 5+ years of GMP testing using capillary electrophoresis techniques in an FDA-regulated biotechnology, pharmaceutical company is required.

Nice To Haves

Bachelor’s degree in Chemistry, Biology, Molecular Biology, Biotechnology, Biochemistry, or related scientific discipline preferred.
Master’s degree and 4+ years of relative experience preferred.

Responsibilities

Lead the QC Chemistry (CE) laboratory daily workflow.
Establish and maintain QC Chemistry (CE) laboratory related quality systems to ensure conformance with regulations and BeOne Global quality standards.
Manage QC Chemistry (CE) laboratory routine operations, including but not limited to validation, SOPs, specifications, testing records, personnel training and assessment, scheduling, etc.
Ensure QC Chemistry (CE) laboratory compliance with Environmental Health and Safety (EHS) standards.
Ensure timely completion of testing (e.g., In-process control, DS release, DP release, and stability testing) to ensure timely generation and reporting of test results in support of manufacturing operations.
Review of laboratory test results, ensuring adherence to Good Documentation Practices.
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.
Ensure that the QC Chemistry (CE) laboratory meets or improves on budget, cost, volume, and efficiency targets (KPIs) in line with business objectives.
Manage direct reports from QC Chemistry (CE) laboratory.