Principal Scientist – Technology Transfer & New Technologies

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Position Summary

The Principal Process Engineer/Scientist acts as a technology transfer lead in the parenteral manufacturing MS&T group to be based in New Brunswick, NJ.  This position is accountable for the technical interface between the sending and receiving sites to ensure design and transfer of robust manufacturing processes for new products and key lifecycle parenteral products. This position is the principle subject matter expert and process owner for the end-to-end manufacturing process for liquids and lyophilized parenteral products at Bristol Myers Squibb. Ensures processes are designed and validated per applicable cGMPs, BMS procedures, and that processes are defined consistent with regulatory filings.  This position will also work on new technology initiatives for the sterile network, including evaluation and testing to verify the technology is suitable for sterile processing applications.  This position must comply with all Security guidelines, Environmental Health and Safety regulations and the current Good Manufacturing Practices. The role will also be responsible for review and authoring of key CMC submissions, along with setting relevant standards and creating /maintaining associated tech transfer business processes. This position will report into the Senior Director of Manufacturing Science and Technology, Parenteral MS&T and is located in New Brunswick, New Jersey USA.

Duties/Responsibilities

• Leads parenteral technology transfer projects for either key lifecycle biologic parenteral products or products in the late stage pipeline intended for commercialization, including the establishment of the process/parameters for each unit operation of the process, and up until the completion of process performance qualification and subsequent CMC filing activities.
• Development, characterization, optimization and troubleshooting product and manufacturing processes of parenteral dosage forms.
• Performs Design of Experiments and Process Risk Assessment (FMEA) activities to establish appropriate process control strategies.
• Designs, prepares, and reviews technology transfer protocols, methods/processes, experimental and/or authoring plans and/or templates as appropriate. Responsible to create, maintain and harmonize key tech transfer business processes.
• 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.  Partners with site operations to provide a parenteral manufacturing process that is sustainable for future product supply.  Partners with existing sites in the network to incorporate lessons learned from ‘sending’ sites for an optimized manufacturing process.
• Representative on global supply strategy groups/site forums and to relevant stakeholders across the company.
• Evaluates new technology through a combination of industry benchmarking, equipment vendor interactions, generation/execution of technical protocols and/or other means to verify the technology is suitable for either sterile processing application and/or downstream processing steps in a sterile operation.  Works in conjunction with internal manufacturing sites and key stakeholders to evaluate new technology and advance towards establishing it within the DP mfg network.
• Leads, motivates, mentors, and develops team members to meet and exceed plant and company goals and objectives.
• Develops and maintains effective working relationships with other division groups in support of technology transfer, validation, and process support activities and establishes strong working relationships with the BMS internal manufacturing sites.
• Responsible to