Job Description
Principal Scientist, Sterile Drug Product Technology Transfer (Manufacturing Science & Technology)Working with UsChallenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity. Take your career farther than you thought possible.The RoleThis permanent Sterile Drug Product Technical Transfer Principal Scientist (Manufacturing, Science & Technology), position acts as a technology transfer lead in the Parenteral MS&T group. 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 role ensures processes are designed and validated per applicable cGMPs, BMS procedures, and that processes are defined consistent with regulatory filings. The role will also be responsible for review and authoring of key CMC submissions, along with setting relevant standards and creating /maintaining associated technical transfer business processes.This position will report into the Associate Director within Biologics Manufacturing Science & Technology, Cruiserath Biologics. The successful candidate will lead a cross functional technical team with both direct and matrix responsibility to ensure project delivery across the technical transfer project.Key Duties and ResponsibilitiesAccountable for leading the matrix team which will deliver the technology transfer biologics drug product project for the Cruiserath Sterile Drug Product facility, including oversight of process design, validation and regulatory package authoring and successful inspection and approval.Leads parenteral technology transfer projects for key lifecycle biologic parenteral products, 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, characterisation, optimisation 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 harmonise key tech transfer business processes.Leads the selection and qualification of product contact and indirect product contact materials. Designs single use systems for aseptic processing, fluid transfer, and sterile filtration. Selects and qualifies primary packaging components to ensure optimum performance during processing and integral container closure over shelf life.Partners with the 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.Develops and maintains effective working relationships with other division groups in support of technology transfer, validation, and process support activities.Responsible to review and co-author key CMC sections.Drives effective working relationships with other functional organizations, such as Quality, Operations, Engineering, Global Regulatory Science, Technical Product Teams and others, both internally and externally to the site.Qualifications, Knowledge and Skills requiredDemonstrated experience in parenteral operations: aseptic processing, sterilisation, sterile filtration, isolator technology, lyophilisation, bulk vial & pre-filled syringe operations.Strong knowledge of global regulatory requirements related to the design and control of these processes.Knowledge of SOPs, cGMPs and GLPs and the ability to work and manage within a regulatory environment.Demonstrated experience with the execution of technology transfer and scale up programs for commercial drug product manufacturing processes.Familiarity with Design of Experiments, Quality by Design, and Quality Risk Management concepts commonly employed in pharmaceutical manufacturing.Experience with Technical Transfer of new processes is essential, as well as experience interacting with regulatory agencies.Demonstrated ability to influence work cross functionally in a matrix environment during startup and into commercial manufacture.Work strategically, excellent organisational skills and the ability to successfully manage multiple programs and create a high-performance work environment.Strong strategic and analytical thinking, problem solving and rapid decision-making skills.Why you should applyYou 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.On-site ProtocolBMS has a diverse occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role.BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters. #J-18808-Ljbffr