Senior Manager, External Manufacturing Biologics, Quality Operations Project Lead
vor 3 Wochen
Bristol Myers Squibb is a company that is dedicated to transforming patients' lives through science. We are a global biopharmaceutical company that is passionate about discovering, developing, and delivering innovative medicines that make a meaningful difference in the lives of patients.
Job SummaryWe are seeking a Senior Manager, External Manufacturing Biologics, Quality Operations Project Lead to join our team. As a Senior Manager, you will be responsible for leading quality operations projects in our external manufacturing network. You will represent Bristol Myers Squibb on process validation, scale-up, or technical transfer project teams and carry out quality and compliance oversight and expertise.
Key Responsibilities- Ensure all quality deliverables related to manufacturing validation projects, scale-up, TT projects are issued timely with high quality - meet the quality standard and cGMP regulations set by applicable health authorities and BMS procedures.
- Partner with project stakeholders to jointly define goals, action plans and deliverables aimed at ensuring successful and compliant project execution.
- Ensure timely reporting and escalation of quality issues.
- Ensure Quality by Design (QbD) principles are implemented in all projects.
- Participate in facility/ process gap assessments and risk assessments on Bio manufacturing processes.
- Directly interface with CMO QA and project management regarding study plans, protocols and reports.
- Input, review, approve deviation, change control, batch documentation relevant to validation project.
- Work with CMOs, vendors and external analytical laboratories to evaluate their audit and inspection readiness and work with these groups to ensure that appropriate corrective actions are made in advance of audits/inspections to support BMS expectations and successful outcomes.
- Assist with commercialization quality-related activities on the new products transferred or launched to/from CMOs.
- Provide quality support during self-inspections, internal audits, and regulatory agency inspections at contract manufacturers.
- Escalate issues to senior management to ensure that issues are resolved to support BMS business and compliance requirements.
- Minimum BS (M.Sc. Preferred) degree in relevant scientific discipline e.g. Biochemistry, Microbiology, Pharmacy, Chemistry, Biological Sciences or Related Pharmaceutical Science.
- Minimum of 8 years experience in (bio-)pharmaceutical operations.
- At least 4 years' Quality Assurance experience in commercial.
- Experience in contract manufacturing.
- Experience with designing, leading or supporting process validation, scale-up, technical transfers of biologic and/or sterile product.
- Experience in pharmaceutical product manufacturing, with demonstrated expertise with one or more of the following: biologic drug substance or drug product manufacturing, aseptic drug product manufacturing, biologic combination products.
- Hands-on experience and/or education in Microbiology/Hygiene and aseptic operations is highly desirable.
- Experience in supply chain ERP systems or SAP and Infinity/Trackwise.
Bristol Myers Squibb offers a wide range of benefits and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. We are committed to creating a diverse and inclusive work environment that values and respects the contributions of all employees.
We are an equal opportunity employer and welcome applications from diverse candidates. If you are passionate about transforming patients' lives through science, we encourage you to apply for this exciting opportunity.
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