Process Development Engineer, Device & Packaging - Brunswick NJ

Process Development Engineer, Device and Packaging Development

Job Type: Full-Time

Location:

New Brunswick, NJ

Drug Product Development (DPD) Our Drug Product Development team is committed to CMC design, development, and commercialization of innovative drug products to improve patient lives. We leverage the best people, collaboration, and cutting-edge innovation to achieve this commitment. BMS's internal engine of innovation includes unrivaled industry leading expertise in CMC development of small molecules, protein biotherapeutics, protein degraders, and other therapeutic modalities.

We collaborate closely with our colleagues in R&D and Commercial to design our drug products. Here, you'll get the chance to grow and thrive through opportunities that are uncommon in scale and scope.

Position Summary:

The Sterile Product and Device Development team within the Drug Product Development team and greater Product Development and Supply organization supports the BMS pipeline to create patient centric products. We now have a vacancy for a Process Development Engineer to join our team and contribute to our success in meeting the needs of our business and our patients.

The Process Development Engineer, Device and Packaging Development is an individual contributor accountable for the following:

• Under the general guidance, the Process Development Engineer will contribute to the development of fill finish and device assembly processes for sterile drug products and drug-device combination products, supporting clinical introduction and commercial launch.
• Collaborate with Clinical and Commercial Manufacturing to develop robust fill-finish and device assembly processes for new products, from early device and combination product development through prototyping, scale up, clinical, and commercialization.
• Participate in design for manufacturing (DFM) activities and process assessments to identify fits/gaps for new products, recommend manufacturing-process strategy, and support manufacturing site selection activities as needed.
• Participate in Design Reviews to ensure design robustness and manufacturability.
• Support knowledge transfer into internal and external manufacturing sites (CMOs) — including component specifications, test methods, equipment specifications, vendor / equipment selection, vendor management, factory acceptance testing (FAT), and qualification — and assist in the development and execution of IQ/OQ/PQ as well as process validations for combination products in accordance with established regulations, corporate policies and procedures.
• Provide technical support to manufacturing sites in close partnership with Clinical and Commercial Manufacturing to sustain product and process robustness and improve equipment performance, productivity, and asset utilization, including ongoing process performance metrics where applicable.
• Support product or process improvement and optimization at internal and external sites utilizing Lean and Six Sigma methodologies and support process risk assessment activities to identify critical process parameters and develop control plans to mitigate risks.
• Evaluate post design transfer changes (component, product, process) for impact on the manufacturing process, documentation, and design control elements, working with the manufacturing site, R&D, and Quality to assess risk/impact based on Design History File and in accordance with Design Controls.