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BeiGene Associate Director, Analytical Quality Control in Hopewell, New Jersey

General Description:

Manages QC analytical activities to support GMP manufacturing, including testing and release of raw materials, intermediates and finished products under FDA/EU regulations, applicable International Regulations and BeiGene processes procedures. Develops and implements quality control processes and procedures and supports regulatory compliance inspections.

To ensure the efficient and effective day to day running of the department

Essential Functions of the job :

  • Establish, update, implement, and enforce Quality Control procedures, specifications and test methods (chemistry and biochemistry) consistent with cGMP, regulations, appropriate compendia, and BeiGene policies and standards.

  • Manage the QC sample management program, including management of on-test samples, retention samples, reference standards, and critical reagents.

  • Establish and manage the QC stability program. Ensure timely completion of stability testing and generation of stability reports in support of regulatory submission.

  • Ensure timely generation of certificates of analyses (COA) for raw materials, product intermediates, DS and DP in support of manufacturing operations.

  • Manage the raw material sampling program in a clean room environment.

  • Ensure timely completion of testing (e.g., DS, DP release and stability testing, raw materials testing) to ensure timely generation and reporting of test results in support of manufacturing operations.

  • Provide QC staff with technical guidance on chemistry/biochemistry test methods and relevant procedures. Lead the team to build up analytical capability for large molecule products to further support company's biologics business.

  • Ensure laboratory equipment and system qualification, validation and life cycle management.

  • Ensure calibration and maintenance of laboratory equipment and systems.

  • Ensure appropriate investigation of OOS, discrepancies, and invalid assays. Ensure appropriate CAPAs are implemented to prevent recurrence.

  • Ensure that the requirements for GMP, corporate standards or regulatory are met within the QC areas.

  • Participate in internal and external GMP audits, as needed.

  • Ensure the development of departmental SOPs and analytical methods for chemistry and biochemistry testing (writing, revising and approving), ensuring regulatory compliance in conjunction with being ‘fit for purpose’ operationally and commercially.

  • Ensure all QC activities are performed in accordance with GMP, company SOPs and Health and Safety policies.

  • Manage all method transfer and method validation activities for chemistry and biochemistry test methods, including transfer/validation strategy and approval of protocols and reports.

  • Managing, motivating, coaching and mentoring direct reports, to higher levels of management capability.

  • Undertaking any other duties, either for this department or any other department within the business, which may be requested by the Line Manager, for which training and/or an explanation has been provided and understood.

Core Competencies, Knowledge and Skill Requirements

  • Scientific degree (ideally pharmacy, pharmaceutical sciences, chemistry or related).

  • Minimum of 10 years’ experience in biological drug product quality control in an FDA-regulated biotechnology, pharmaceutical company with progressive levels of responsibility are required.

  • Minimum of 7 years’ experience in management, with training and knowledge of Data Integrity Guidance and Data Management Systems utilized in a Quality Operation.

  • Impressive, demonstrable track record and skills/experience gained within a similar position(s), at a similar level.

  • Wide knowledge of analytical methods and electronic systems (LIMS, SAP) used in QC Lab.

  • Strong leadership/team management skills and experience.

  • Credible and confident communicator (written and verbal) at all levels.

  • Strategic thinker with the ability to influence at a senior level.

  • Highly customer focused.

  • 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.

  • Highly Desirable:

  • Good IT skills e.g. Microsoft Office (Word, Excel and Outlook)

Significant Contacts

  • Interacts with all levels of BeiGene employees;

Supervisory Responsibilities:

  • Manage direct reports from QC

Education Required:

Bachelor’s degree, preferably in Science with 8+ years experience, or MS with 6+ years experience.

Computer Skills:

  • Strong PC literacy required; MSOffice skills (Outlook, Word, Excel, PowerPoint)

Other Qualifications:

No

Travel:

  • Must be willing to travel approximately 10%

Ability to work on a computer for extended periods of time

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.

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