• Sr. Manager, Clinical Supply Chain

    BeOne Medicines (Cambridge, MA)


    BeOne Medicines USA, Inc. (f/ka BeiGene) seeks Sr. Manager, Clinical Supply Chain in Cambridge, MA:

    Job Duties:

    + Represent the Clinical Supply Chain on Clinical Study Teams (CST) and provide a high service level to internal stakeholders (e.g. Clinical Operations, Regulatory, Quality, CMC).

    + Work with Clinical Operations to understand clinical demand requirements and ensure alignment with study teams to supply plans and timelines.

    + Create supply and inventory plans and develop production schedules for clinical trial materials.

    + Manage GMP inventory throughout the supply chain, develop inventory reports, manage upcoming expiry, and ensure drug accountability.

    + Manage the relationship and oversee daily activities for FG label & pack CMOs and distribution vendors.

    + Responsible for investigation of exceptions to determine root causes, implement CAPAs and drive closure. Ensure label text and proofs are in accordance with applicable rules, regulations, product specifications, and clinical study protocol(s).

    + Develop supply strategies to maximize supply efficiency, minimize waste while identifying risk and develop risk mitigation plans.

    + Lead cross functional projects and process improvements related to drug supply.

    + Leads staff who are in supportive roles for supply planning and business process development.

     

    Telecommuting is an option.

     

    **Minimum Requirements:** Master’s degree (or its foreign degree equivalent) in Biotechnology, Engineering (any field), or a related quantitative discipline, and one (1) year of experience in the job offered or in any occupation in related field

    **Special Skill Requirements:** (1) global clinical trials and the drug development process; (2) vendor oversight and managing external partnerships and relations; (3) comprehensive global pharmaceutical regulatory requirements (cGMP, GDP, and GCP); (4) IRT system setup and functionality and proficiency with Excel modeling; (5) deviation investigation and CAPA implementation. Any suitable combination of education, training and/or experience is acceptable.

     

    Telecommuting is an option.

     

    Disregard the below range, the selected candidate will earn a wage of $152,000.00 - $202,000.00 per annum.

     

    Submit resume with references to: Req.#: 24-150806 at: ATTN: Amy Nobriga, [email protected] .

    \#LI-DNI

    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.