Senior Scientist, Sterile Drug Product Technical Transfer (Manufacturing, Science & Technology) Apply locations Cruiserath - IE time type Full time posted on Posted 2 Days Ago job requisition id R1587634
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The Role BMS Cruiserath Biologics is seeking to recruit on a fixed-term contract (maternity cover for 12 months) Senior Scientist, Sterile Drug Product Technical Transfer (Manufacturing, Science & Technology), reporting to Associate Director, Sterile Drug Product MS&T.
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.
Key Duties and 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. 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 characterization 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. Prepare technical assessments on new materials and components.
Prepare protocols and execute qualification of new materials and components. 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 effective working relationships with other division groups in support of technology transfer, validation, and process support activities. Responsible to co-author and review key CMC section of regulatory filings. Maintain compliance to industry standards and implement best practices across knowledge transfer, technology transfer, and process validation. Qualifications, Knowledge & Experience Experienced in parenteral operations including aseptic processing, sterilisation, sterile filtration, isolator technology, lyophilisation, and fill-finish operations. Strong knowledge of global regulatory requirements, especially EU GMP guidelines and FDA CFR guidelines, related to the design and control of these processes. Experienced with the execution of technology transfer and scale up projects for commercial drug product manufacturing processes. Familiarity with Design of Experiments, Quality by Design, and Quality Risk Management concepts commonly employed in pharmaceutical manufacturing. Proven ability to lead complex investigations relating to equipment, processes and systems associated with aseptic manufacture of drug products. Experienced in sourcing and qualification of vial and/or syringe container closure and drug delivery systems. Demonstrated ability to influence work cross functionally in a matrix environment during startup and into commercial manufacture. Excellent organisational skills, data science knowledge, and statistical skills are required. Problem solving and project management ability, as well as lean manufacturing experience is desired. Why you should apply You will help patients in their fight against serious diseases You will be part of a company that encourages excellence and innovation, respects diversity, develops leaders and values its employees. You'll get a competitive salary and a great benefits package including, but not only, an annual bonus, pension contribution, family health insurance, 27 days annual leave, access to BMS Cruiserath on-site gym and life assurance. #LI-Hybrid Uniquely Interesting Work, Life-changing Careers
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Each of us is empowered to apply our individual talents and unique perspectives in an inclusive culture, promoting diversity in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.
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