Senior Production Manager, External Manufacturing

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.

The primary focus of the Sr Production Manager, External Manufacturing role is to oversee manufacturing activities at specific BMSs 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 CMOs 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
  • Function as a key point of contact for all BMS interests/activities at Contract Manufacturing Organizations (CMOs)
  • Build and maintain strategic relationships within the CMO organization as well as key internal stakeholders, developing a partnership approach
  • Live and support deployment of the BMS values
  • Act as a resource for CMO stakeholders on their requests to BMS stakeholders and vice versa
• 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 BMSs needs, ensuring compliant and timely manufacturing, OTIF shipments, quality compliance and cost management) - 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
  • Manage and track CMO performance prior to (preparation), during (direct oversight) and after (campaign summaries/reports) manufacturing
  • 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 and escalate business-critical issues effecting Compliance, Operations and Management
  • Participate in regular staff and governance meetings to agree on priorities and tactics
  • Maintain and communicate list of unbudgeted and extraordinary charges for resolution with CMO and visibility to management
• 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
  • Support product, technical and business process lifecycle management activities
  • Lead or support other CMO- or 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

Required Qualifications

• Bachelors degree required, ideally in; cell biology, or closely related disciplines.
• 5+ years of experience working in biopharmaceutical manufacturing, quality, or biopharmaceutical development.
• Strong quality and compliance background in a commercial GMP operational environment; sound working knowledge of health authority regulations
• Strong technical background in aseptic operations.
• Solid project management skills and experience managing complex projects.
• Ability to expresses ones self clearly and concisely, by adjusting style, language and/or terminology as appropriate for the audience.
• Strong leadership and an innate ability to collaborate and build relationships is critical.
• Ability to work calmly and make sound decisions in an environment of uncertainty and change
• Flexibility to work shift hours required to cover critical process steps
• Represent BMS as a leader when issues arise.

Education Requirements

• Bachelors degree in Life Sciences or related discipline (Immunology, Microbiology, Cell Biology, Engineering, etc.).
• Advanced degree in Life Sciences preferred.

BMSCART VETERAN #LI-Hybrid

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.

Physical presence at the BMS worksite or physical presence in the field is an essential job function of this role which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and enhances the Company culture.

To protect the safety of our workforce, customers, patients and communities, the policy of the Company requires all employees and workers in the U.S. and Puerto Rico to be fully vaccinated against COVID-19, unless they have received an exception based on an approved request for a medical or religious reasonable accommodation. Therefore, all BMS applicants seeking a role located in the U.S. and Puerto Rico must confirm that they have already received or are willing to receive the full COVID-19 vaccination by their start date as a qualification of the role and condition of employment. This requirement is subject to state and local law restrictions and may not be applicable to employees working in certain jurisdictions such as Montana. This requirement is also subject to discussions with collective bargaining representatives in the U.S.

Our company is committed to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace adjustments and ongoing support in their roles. Applicants can request an approval of accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application or if you are applying to a role based in the U.S. or Puerto Rico and you believe that you are unable to receive a COVID-19 vaccine due to a medical condition or sincerely held religious belief, during or any part of the recruitment process, please direct your inquiries to adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.

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