Senior Scientist, Sterile Drug Product Technical Transfer (Manufacturing, Science & Technology)

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Bristol Myers Squibb Ireland

Bristol Myers Squibb has been in operation in Ireland since 1964, employing over 650 people across a range of activities and business units. Located in Dublin, Cruiserath Biologics Campus, a one billion Multi-Product Cell Culture Biologics Manufacturing facility plays a central role in the Global Product Development and Supply (GPS) network as the company’s first European biologics manufacturing facility. This state of the art facility will produce multiple therapies for the company’s growing biologics portfolio. Global Biologics Laboratory (GBL) responsible for the release testing of Biologics Drug product for the network, is also based on the Cruiserath Biologics Campus. BMS Cruiserath has been awarded “Biopharma Company of the Year 2019” in the Irish Pharma Industry Awards and is certified as a Great Place to Work since 2017, including as a Great Place to Work for Women in 2020, 2021 and 2022.

Position Summary

This Sterile Drug Product Technical Transfer Senior Scientist (Manufacturing, Science & Technology) supports key technology transfer activities in the Parenteral MS&T group. This position supports 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 role ensures processes are transferred and validated per applicable cGMPs, BMS procedures, and that processes are defined consistent with regulatory filings. The role will also be responsible for scale up activities, authoring key technical documents, process performance qualification, and drafting CMC submissions. This position will report into the Tech Transfer Lead within Biologics Manufacturing Science & Technology, Cruiserath Biologics. The successful candidate will be part of a cross functional technical team to ensure project delivery across the technical transfer project.

Key Responsibilities

• Perform a technical expert role which will support the technology transfer of biologics drug products for the Cruiserath Sterile Drug Product facility. 

• Perform a technical expert role in various areas of aseptic manufacturing of parenteral dosage including equipment preparation, formulation, aseptic vial and syringe filling, and automated visual inspection.

• Provide technical support for new raw materials, excipients, single use systems, and components.  Prepare protocols and execute qualification of new materials and components. Lead/Support materials workstreams for site start up readiness.

• Support parenteral technology transfer projects for key lifecycle biologic parenteral products, including the establishment of the process/parameters for each unit operation of the process.

• Execute development studies, product characterisation studies, process optimisation and troubleshooting of manufacturing processes of parenteral dosage forms.

• Perform Design of Experiments and Process Risk Assessment (FMEA) activities to establish appropriate process control strategies.

• Prepare and review technology transfer plans, development study protocols, validation protocols, technical reports, and operational procedures, as appropriate.

• Work cross functionally to lead any validation studies, process performance qualification and new product introductions in the SDP manufacturing facility.

• Contribute to technical decision-making that impacts project deliverables and schedule for facility start up.

• Develop and maintain effect