External Manufacturing Manager, Cell Therapy

Job content

At Bristol Myers Squibb, we are inspired by a single vision – transforming patients’ lives through science. In oncology, hematology, immunology and cardiovascular disease – and one of the most diverse and promising pipelines in the industry – each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.

Job Summary

The primary focus of the External Manufacturing Production Manager, Cell Therapy role is to oversee cell therapy manufacturing activities at specific BMS’s Contract Manufacturing Organizations (CMOs) and to implement our vision for this business-critical function. We are looking for a candidate with the breadth of professional experience and the drive to work with both internal and external partners to define and manage the ongoing cGMP supply of concerned products. The right candidate should have the ability to understand the challenges and make proactive decisions after anticipating cross-functional impact. The successful candidate should have a strong operational, quality, compliance, and technical background, with proven project management and supplier management abilities. The candidate will be requested to travel to the CMO’s site for potentially frequent and / or extended periods of time with a requirement to occasionally travel elsewhere as needed. The successful candidate will be a key member of the Virtual Plant Team (VPT) contributing to the broader External Manufacturing group activities.

As we are “changing medicine for good,” we are looking for leaders who can work in a highly matrixed and cross-functional organizations, against tight deadlines, and with world-class contract manufacturers and business leaders alike.

Primary Responsibilities

• 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 Strategic 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.
    
  Required Qualifications
  
  • Bachelor’s degree required, ideally in cell biology, biotechnology, biochemistry, or closely related disciplines
  • Minimum 5, preferably 7 years of experience working in cell therapy or biopharmaceutical manufacturing, quality, Manufacturing Science and Technology, Supply Chain, or biopharmaceutical development
  • Strong quality and compliance background in a commercial and/or clinical GMP operational environment; sound working knowledge of health authority regulations
  • Technical background in aseptic operations is a plus
  • Solid project management skills and experience managing complex projects
  • Ability to expresses oneself clearly and concisely, by adjusting style, language and/or terminology as appropriate for the audience
  • Strong leadership and ability to collaborate and build relationships is critical
  • Ability to work calmly and make sound decisions in an environment of uncertainty and change, including when facing technical, manufacturing- or supply-related issues
  • Flexibility to work shift hours may occasionally be required to cover critical process steps
  • Ability to frequently travel, mainly to the CMO(s) under responsibility, is required
    
  Education Requirements
  
  • Bachelor’s degree in Life Sciences ideally in cell biology, biotechnology, biochemistry, or closely related disciplines
  • Project management experience
  • Advanced degree in Life Sciences preferred
    
  Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.
  
  Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives.