Scientist, Manufacturing Science and Technology; MS&T

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.

• Provide technical support and leadership to the External Manufacturing Organization and Contract Manufacturing Organizations (CMOs).
• Provide technical support and leadership to the BMS Internal Manufacturing Organization.
• Ensure the transfer of robust manufacturing processes.
• Ensure robust process performance during commercial manufacture by use of continuous process monitoring and OPEX.

• Provision of ongoing technical support and oversight for a portfolio of Drug Products, ensuring compliance and security of supply - metrics review, investigation close-out, change control review, annual reviews and continuous improvement
• Driving process capability analysis to assess process robustness. Identifying and executing process robustness improvement projects, where required
• Supporting CMO/vendor selection – preparation of technical information packages, participation in due diligence and site assessments, technical evaluation of requests for information (RFIs) and requests for proposal (RFPs)
• Managing technology transfers as required
• Technical oversight and direction for process validation, as required
• Providing technical guidance in the understanding of root causes and corrective and preventive action (CAPA) identification for out of trend or out of specification results or deviations for DP processes
• Driving the use of strategies, resources and processes (OPEX, etc.) to improve processing efficiency and to ensure optimized technical support for manufacturing, technical transfer and scale-up of processes
• Work with assigned CMOs and/ or internal site to identify and agree potential process optimizations
• Reduce costs associated with existing processes
• Participate and lead on teams for cost reduction projects
• Provide support for change management
• Support all regulatory activities associated with changes to assigned products and new products
• Support operational management of CMO as per Supplier Relationship Management governance structure
• Represent Manufacturing Science and Technology on project teams and works closely with Quality Assurance (QA), Global Procurement, Supply Chain, Supply Relationship Manager (SRM), Product Development (PD), Internal manufacturing site (as applicable), and project team members in developing strategies and problem-solving efforts.
• Product robustness (where required) - technical lead for creation of process robustness monitoring plan, process control strategy, and provision of technical oversight of CMO sites to ensure continuous process monitoring for all products in scope.
• Where required develop program of experimental work to support investigations and work with PD, CMOs and external resources as appropriate to implement the program of work.

• Documentation (Transfer documentation, Appraisals, technical memos and reports, Regulatory filing, etc.)
• Deviation investigations
• Technical support for Change Control system
• Technical support for Validation and Continued Process Verification (CPV)
• Training Gap Analysis and Planning

Required Competencies:

The role holder will have expert knowledge in one or more of the following areas:

• Drug Product - Oral Solid Dosage…