External Manufacturing Manager, Cell Therapy
vor 2 Wochen
Bei Bristol Myers Squibb lassen wir uns von einer einzigen Vision inspirieren - die Veränderung des Lebens von Patienten durch Wissenschaft. In den Bereichen Onkologie, Hämatologie, Immunologie und Herz-Kreislauf-Erkrankungen - und eine der vielfältigsten und vielversprechendsten Pipelines der Branche - trägt jeder unserer leidenschaftlichen Kollegen zu Innovationen bei, die bedeutende Veränderungen vorantreiben. Wir verleihen jeder Therapie, für die wir Pionierarbeit leisten, eine menschliche Note. Kommen Sie zu Bristol Myers Squibb und machen Sie einen Unterschied.
The key deliverables for this role are to ensure reliable supply of external manufacturing operations through:
General and team
- Responsible for operational aspects of CMO management, ensuring compliant, efficient, and timely production and delivery of products
- Ensures smooth execution of manufacturing-related projects and process improvements, acting as a resource for CMO stakeholders on their requests to BMS stakeholders and vice versa
- Function as a key point of contact for all BMS interests/activities at Contract Manufacturing Organizations (CMOs)
- Support the Supplier Relationship Manager in building and maintaining mutually beneficial relationships with the CMO organization(s) in scope, as well as with key internal stakeholders, developing a partnership approach
- Live and support deployment of the BMS values
Production
- Provide operational oversight of CMOs to ensure all deliverables meet or exceed BMS requirements. This includes but is not limited to negotiating manufacturing slots aligned with BMS’s needs, ensuring compliant and timely manufacturing, on-time / in-full (OTIF) shipments, quality compliance and cost management, ensuring proper approval and execution of change control and lifecycle management initiatives, supporting the resolution of deviations etc. Be the BMS ‘eyes and ears’ at the CMO for flawless execution of commercial operations
- Leverage BMS VPT stakeholders to provide guidance to CMOs and ensure cross-functional alignment on priorities and deliverables
- Lead change management, issue resolution and adherence to agreed deliverables.
- Manage and track CMO performance prior to (preparation), during (direct oversight) and after (campaign summaries/reports) manufacturing.
- Compiles key performance indicator reports.
- Coordinate the preparation of governance meetings and management reviews
- In close relation with CMO and BMS VPT stakeholders, lead, prioritize and track efficient execution and documentation of key activities to meet BMS requirements. This includes, but is not limited to initiation, execution, tracking and closure of change controls, investigations, and deviations.
- Identify, escalate, and participate in the resolution of business-critical issues effecting Compliance, Operations and Management
- Participate in regular staff and governance meetings to agree on priorities and tactics
Project management
- Manage a portfolio of multiple cross-functional external manufacturing projects, with a focus on developing and maintaining overall project plan objectives and timelines
- Collaborate with CMO and internal stakeholders to understand planned changes, set priorities, define required budget and resources, and manage the end-to-end implementation process including but not limited to change controls and impact assessments. Effectively communicate status and expectations internally and to CMO. Escalate as needed.
- Support product, technical and business process lifecycle management activities
- Maintain action trackers, SharePoint Forms and Risk Registers.
- Lead or support other CMO- or Virtual Plant Team (VPT)-related projects
Performance and continuous improvement
- Act as the key liaison to facilitate post-campaign / periodical (as applicable) and CAPA effectiveness review at CMOs
- Establish a robust tracking and reporting process to ensure compliance with internal/external audit observation deadlines or other regulatory commitments.
- Facilitate collation of data to track CMO and VPT performance and compliance on metrics including but not limited to adherence to contractual agreements such as on-time-in-full (OTIF) delivery and release, spend/budget, product quality and supply integrity
- Facilitate process improvement initiatives with CMO, VPT and supporting business processes
- Track and ensure compliant and timely execution and closure of responses to audit and inspection observations or of other regulatory commitments
- Create and maintain process maps and tools, maintain related SOPs and work instructions up to date, in collaboration with other VPT representatives.
- Collaborate with other VPTs to exchange experience and best practices
- Support root cause analysis and risk assessments
- Support budget management and tracking, initiate project and change orders, track invoices and forecast CMO spend.
**Qualifications**
- Bachelor’s degree required, ideally in cell biology,
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