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General Description:

Manages all Quality Control (QC) Physicochemistry laboratory 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 Physicochemistry procedures and supports regulatory compliance inspections. Ensures efficient and effective day to day operations of the Physicochemistry laboratory. This position reports to the Senior Manager QC and is located full time at the Hopewell, NJ site.

Essential Functions of the Job:

+ Lead the QC Physicochemistry laboratory daily workflow.

+ Establish and maintain QC Physicochemistry laboratory related quality systems to ensure conformance with regulations and BeOne Global quality standards.

+ Manage QC Physicochemistry laboratory routine operations, including but not limited to validation, SOPs, specifications, testing records, personnel training and assessment, scheduling, etc.

+ Ensure Physicochemistry 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 Physicochemistry laboratory meets or improves on budget, cost, volume, and efficiency targets (KPIs) in line with business objectives.

+ 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 physicochemistry analytical methods such as GC, HPLC, UPLC, IEF, TOC, UV, FTIR, 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.

+ Interacts with all levels of BeOne employees

+ Undertake any other duties as required.

Supervisory Responsibilities:

+ Manage direct reports from QC Physicochemistry laboratory.

+ 2+ years of managerial experience directly managing people required.

+ Leadership experience leading teams, projects, programs or directing the allocation of resources.

Computer Skills:

+ Strong PC literacy required; MS Office skills (Outlook, Word, Excel, PowerPoint).

+ Ability to work on a computer for extended periods of time

**Travel:** Must be willing to travel approximately 10%

Education/Experience:

+ Bachelor of Science degree and 5+ years of experience in an FDA-regulated biotechnology, pharmaceutical company with progressive levels of responsibility required.

+ Bachelor’s in Chemistry, Biology, Molecular Biology, Biotechnology, Biochemistry, or related scientific discipline preferred.

+ Master’s degree and 4+ years of relative experience preferred.

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.