About the Job
Bristol-Myers Squibb is a global biopharmaceutical company firmly focused on its mission to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. Our BioPharma strategy uniquely combines the reach and resources of a major pharma company with the entrepreneurial spirit and agility of a successful biotech company. With this strategy, we focus on the needs of health care professionals, patients, employees, shareholders and our communities, giving maximum priority to developing innovative medicines, accelerating pipeline development, delivering solid growth, continuing to manage costs, and adhering to high standards of business conduct and ethics.
The Process Scientist/Engineer provides technical leadership related to new and existing sterile drug products. This position is accountable for the technical interface with R&D to ensure design and transfer of robust manufacturing processes for new products and key life cycle management products, development of new technology for optimization and continuous improvement in manufacturing operations, providing specialized expertise as necessary to complement site capabilities for criticial investigations or process improvements, setting relevant standards and creating and maintaining associated Directives (e.g, for tech transfer, Product monitoring, etc).
1. Act as a DP tech transfer lead, interfacing with R&D and internal sites or Contract Manufacturing Organizations (CMO’s) for new product development teams. Partner with R&D to ensure manufacturing processes are developed for optimal execution within the Manufacturing and Supply network or designated 3rd parties
2. Act as Product champion for critical biologic drug product assets and owners to identify process robustness risks for key products, develop monitoring plans and risk mitigation and recommend options.
3. Lead Drug Product aspects of the Technical Roadmap/Agenda for inline biologic drug products. This entails prioritization of process and analytical changes to optimize process performance and efficiency over the lifecyle of the product
4. Lead execution of post-market process change activities through partnership with R&D development assets
5. Provide technical justification and direction to enable change control and resolution of key investigations at Contract Manufacturing Organizations (CMO’s)
6. Assess both internal and external manufacturing capabilities against current BMS and industry technical standards for advanced commercial aseptic processing
7. Interact and engage with a core team of specialized experts with necessary capabilities to support the BMS portfolio of products and complement site capabilities
8. Provide assistance to sites globally to resolve significant quality events and manage complex change controls.
9. Work with R&D and manufacturing sites to develop and execute strategy for leveraging new innovative technologies to bring value-driven innovation to site operations.
10. Review and co-author sections of the CMC filing (US and ROW)
11. Identify product cost drivers and identify opportunities for cost reduction early in product/process development or as part of post filing improvements
• Bachelor’s degree in relevant science or engineering discipline (chemistry, pharmacy, biology, chemical engineering or a related pharmaceutical science). Masters or advanced degree preferred.
Experience / Knowledge Desired\:
• Minimum of 6 years experience in the Pharmaceutical or Biotechnology industry in new product and process development and commercialization
• Knowlege in Biologics/sterile/liquid drug product development and commercialization, aseptic processing (Lyo and RTU), fill, finish and inspection Operations.
• Experienced in Technology Transfer and scale up.
• Thorough knowledge of quality systems, Quality by Design, validation principles for product and manufacturing processes, engineering design and process control fundamentals including Analytics.
• Strong understanding of project management systems and tools
• Thorough understanding of regulations, familiarity of regulatory environment and industry trends for drug products, including combination products.
• Working competency of Statistical Process Control and related tools.
• Six Sigma Green/Black Belt certification desirable
• Very strong analytical, technical writing, verbal communication
• Demonstrated ability to
o influence areas not under direct control to achieve objectives
o work strategically, manage multiple programs and create a high performance work environment.
o work in a matrix environment and effectively support the decentralized manufacturing function
o build alignment with business partners including R&D and manufacturing regional and site leaders.
o manage risk and make rapid decisions
o budget, plan and manage resources efficiently