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    Senior Director, US Quality Control - Cranbury, United States - WuXi Biologics

    WuXi Biologics
    WuXi Biologics Cranbury, United States

    2 weeks ago

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    Description
    Senior Director, US Quality Control

    WuXi Biologics is a is a leading global open-access biologics technology platform offering end-to-end solutions to empower organizations to discover, develop, and manufacture biologics from concept to commercial manufacturing.

    WuXi Biologics' achievements are a direct result of the efforts made by our employees. We have built an extraordinary team motivated by our PROUD culture of Passion, Reward, Opportunity, Unity and Determination. WuXi Biologics offers exciting job opportunities and careers around the globe.

    We currently employ over 12,000 people and provide services to more than 600 customers worldwide, including all the top 20 biopharmaceutical companies.


    Responsibilities:

    • Build a QC operations team focused on raw material release testing, assay qualification, manufacturing production sample testing support, batch release testing, and stability testing
    • Lead the QC Labs operation according to the site manufacturing project plan, quality systems, and regulatory requirements. Ensure the effective use of material, equipment, and team in delivering QC part of the project goals with high quality, well documented, on time, and within budget.
    • Collaborate with other departments to create QC operation system to track Lab activity schedule, QC function performance, and provide continuous improvement recommendations to the site, division, and corporate leadership teams
    • As a site leadership team member, actively work with other SLT members to resolve the site issues and enhance the site quality/efficiency and collaboration across departments. Develop QC function policies and procedures with the alignment of the global quality team and quality committee. Drive site-defined operational excellence methodologies throughout QC operations to meet quality and efficiency targets
    • Recruit, train, and retain a high-performance QC team. Create a safety culture, enforce safety measures, and ensure QC staff working in a safe environment. Develop talent and capabilities of the QC teams and align with Site and Corp employee training and development policies.
    • Responsible for QC budget drafting, and maintaining QC operating costs within budget
    • Conduct effective communication internally and externally to ensure alignment between WuXi Biologics and clients
    • Apply industry technical knowledge and experience to support QC Labs design and operation readiness, and lead the corresponding function team to support manufacture site operation.
    • Solid track record of leadership experience in quality control operations to support commercial-scale manufacturing product testing and regulatory BLA filing.

    Qualifications:

    • Ph.
    D. or M.S in Biology, Chemistry, Micrology or related biotechnology discipline with a minimum of 15 years of Quality Control experience in biopharmaceutical or biotech industry

    • Extensive knowledge in analytical and QC operations in the development and commercializing bio-therapeutics.
    • Understand current regulations and industry trends of biologics product development, characterization, and manufacturing testing requirements including cGMP, ICH, EMA, FDA, and other global regulations and guidance.
    • Strong technical background in assay development, pharmaceutical analysis, bioassay, impurity testing, microbiology support, quality control, and stability management.
    • Experiences in raw materials release, environmental monitoring, biosafety, and cell bank testing.
    • Hands-on experience in biopharmaceutical testing such as CE, HPLC, qPCR, ELISA, or Microbiology testing is preferred.
    Support Critical quality attribute establishment, set method transfer and validation strategies, support DS/DP Specification setting

    • Skillful in stability study programs for drug products and participating in regulatory filing and query responses to regulatory authorities.
    • Knowledge of equipment and instrument qualification and validation.
    • Experiences in new technology implementation
    • Familiar with data integrity strategic plan, experiences in building and implementing QC LIMS system, and analytical instrument software validation.
    • Work closely with Manufacturing, Tech Transfer, QA, and Regulatory departments to ensure appropriate testing information is effectively communicated and documented.
    • Provide testing CoA/Batch record and stability data for regulatory filing, draft and review of relevant CMC sections for regulatory submissions
    • Review technical results and report data and supervise troubleshooting and investigation
    • Manage and support staff from technical and regulatory perspectives in the execution of testing, ensure compliance, and handle deviations, investigations, and CAPA.
    • Support internal and external audits and regulatory inspections
    WuXi Biologics is an Equal Opportunity Employer.

    All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

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