Principal Scientist, 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.

Job Summary

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Accountable for the transfer, project management, optimization, and daily support of manufacturing processes across the site and for timeliness of introduction, robustness of the processes, and quality of the products transferred from Research and Development, other BMS sites, or business partners to satisfy or exceed established timing targets and business plans.

The incumbent is the principal subject matter expert and process owner for the end-to-end manufacturing process for liquids and lyophilized parenteral products at Manatí.

Ensures processes are designed and validated per applicable cGMPs, site procedures, and that processes are defined consistent with regulatory filings.

This position must comply with all Security guidelines, Environmental Health and Safety regulations and the current Good Manufacturing Practices.

Major Duties and Responsibilities

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• Performs as Subject Matter Expert in liquid, lyophilized and syringe parenteral processes, and formulation, maintaining a current knowledge base on best industry practices.
• Supports Manatí Technical Transfer projects, including project plan development, team formation and charters for new product transfers occurring at Manatí.
• Develops and executes technology transfer plans in support of new products, effectively integrating site time and event schedules to priorities established through corporate structures.
• Acts as core team member on new product introduction teams for internal R&D, contract manufactured, and Alliance products (e.g., Integrated Development Team, Tech Transfer Team).
• Partners with Innovation Technologies group, Information Management, Engineering Maintenance, and Manufacturing to ensure equipment and automation are capable to deliver the manufacturing processes transferred.
• Assures effective integration of plans and resources to achieve timeliness of process support, productivity, and technology transfer and validation activities associated to product portfolio.
• Performs Design of Experiments and Process Risk Assessment (FMEA) activities to establish appropriate process control strategies.
• Partners with the site management team in the identification of best practices in industry related to technology transfers, pharmaceutical technology to create a competitive advantage.
• Develops and maintains effective working relationships with other division groups in support of technology transfer, validation, productivity and process support activities.
• Leads, motivates, mentors, and provides technical leadership to junior scientists, and develops team members to meet and exceed plant and company goals and objectives.
• Performs as the communication liaison for the transfer, valida...

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