Manager, Manufacturing Support, Sterile Drug Product

At Bristol Myers Squibb, our employees often ask, “Who are you working for?”-a question that fuels collaboration, accountability, and urgency in our work. Our purpose-driven culture inspires us to discover, develop, and deliver innovative medicines to prevail over serious diseases. We offer uniquely interesting and meaningful work, opportunities for growth, and a supportive environment that values inclusion, wellbeing, flexibility, and comprehensive benefits. This is work that transforms the lives of patients, and the careers of those who do it.

Position Summary

BMS Cruiserath Biologics is seeking to recruit a Manager, Manufacturing Support, Sterile Drug Product to support the start-up of our commercial drug product manufacturing facility for its biologics commercial portfolio and clinical pipeline.

Reporting to the Senior Manager of Operations, the Senior Manufacturing Support Specialist will play a key role in the establishing our multi-product commercial Drug Product Facility with both vial and syringe fill finish technology. This shall be achieved by providing technical leadership and input into all phases of the project, such as, CQV, Site Operational Readiness, Technical Transfer, new product introduction and commercialization activities. The successful candidate shall work to implement RFT culture with SDP during start-up.

Post start-up this role will be embedded within the Manufacturing Support team charged with supporting the Operational teams e.g., provide leadership in OE principles, lead complex investigations, support batch disposition and support new product introductions.

The start-up nature of this project will require adaptability & innovation due to the multiple project phases and multiple products onsite. The role will be both challenging & rewarding and will thus ensure that the successful candidate can seize a wide range of development opportunities within BMS.

Key Responsibilities During Start Up

• Senior Manufacturing Support SME for Sterile Drug Product processes such as Formulation, Filling, Lyophilization, Capping and Visual Inspection
• Work with the project design, CQV, & the Automation/CSV teams to facilitate the implementation of the project design and validation of the project for Drug Product Operations.
• Lead/support CQV, Technical Transfer and Operational Readiness activities including but not limited to:
  • MFG Ops input into CQV, Operational Readiness and Tech transfer documentation
  • Support the Ops teams with task-based risk assessment, SOP and OJT development
  • Training Material development
  • MES / MBR Design
  • Material flow, consumable design, room programming
  • CQV support including FAT attendance as required.
• Develop and execute training programs in support of multiproduct manufacturing.
• Development of planning and scheduling tools to support the project and future state routine operations.
• Support establishment of Operational Excellence initiatives e.g., 5S / Std Work / LSW / Kaizen / Problem Solving etc.
• Support development of the operational controls prescribed in the Contamination Control Strategy for Sterile Drug Product
• Mentor and develop members of manufacturing support team.

Key Responsibilities Post Project Delivery

• Manufacturing Support SME for Sterile Drug Product processes such as Formulation, Filling, Lyophilization, Capping and Visual Inspection Provide SME input into cross-functional teams investigating & optimizing manufacturing processes, procedures, and documentation.
• Lead operational related investigations and be the key point of contact for all other technical investigations.
• Own & drive change controls, CAPA’s, investigations, improvement projects and operational safety. Minimize human error and work with operations to remove sources of error.
• Work with Drug Product Associates to generate procedures and training documentation required to enable manufacturing start-up and complete training on time.
• Lead/support delivery of training to SDP team within area of responsibility
• Drives and supports culture of continuous improvement initiatives and safe working practices.
• Lead/support external and internal audits.
• Lead/support the disposition process.
• Lead/support introduction of new products and/or technologies to manufacturing.
• Lead/support Operational Excellence initiatives e.g., 5S / Std Work / LSW / Kaizen / Problem Solving etc.

Qualifications & Experience

A Bachelors in a science, engineering, or related subject

• The successful candidate must possess a Bachelor/Masters in Engineering, or Science related subject.
• 5+ years’ biologics manufacturing experience.
• Experience in start-up desirable
• Experience in new product introduction / technical transfer desirable
• Expertise in sterile drug product manufacturing along with demonstrated proficiency in technical troubleshooting and resolution is essential.
• Ability to support the close out of complex technical investigations.
• Strong working knowledge of systems such as TrackWise, SAP.
• Experience in participating in regulatory inspections such as HPRA, FDA.

Why you should apply

• You will help patients in their fight against serious diseases
• You will be part of a company that encourages excellence and innovation, respects diversity, develops leaders and values its employees.
• You’ll get a competitive salary and a great benefits package including an annual bonus, pension contribution, family medical allowance, 27 days of annual leave, life assurance and on-site gym

#LI-Hybrid

We hire for skills and capabilities, not just credentials - if this role excites you, but doesn’t perfectly match your resume, we encourage you to apply anyway.

How We Work

Where you work matters - because collaboration, innovation and patient impact happen in many settings. Our roles are structured across four work models: site-essential, site-by-design, field-based and remote-by-design. The model assigned to this role is based on its core responsibilities. Learn more at https://careers.bms.com/ways-of-working.

Supporting People with Disabilities

BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to [email protected]. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

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