Principal Scientist, Sterile Drug Product Technical Transfer (Manufacturing, Science & Technology)
at Bristol-Myers Squibb
in
Ireland
Posted on January 8, 2024
Job details
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Principal Scientist, Sterile Drug Product Technical Transfer (Manufacturing, Science & Technology)
Apply locations Cruiserath - IE time type Full time posted on Posted Yesterday job requisition id R1574960 Working with Us Challenging. 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. Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us . 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 and 2021. For more information about Bristol Myers Squibb, visit us at BMS.com/ie The Role BMS Cruiserath Biologics is seeking to recruit on a permanent contract, Principal Scientist, Sterile Drug Product Technical Transfer (Manufacturing, Science & Technology). The person will acts as a technology transfer lead in the parenteral manufacturing 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 filingsThe 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 Responsibilities Accountable 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.
- 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.
- Demonstrated experience in parenteral operations: aseptic processing, sterilisation, sterile filtration, isolator technology, lyophilisation, 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.
- Influence areas not under direct control to achieve objectives.
- Work strategically, excellent organisational skills and the ability to successfully manage multiple programs and create a high-performance work environment.
- Budget, plan and manage resources efficiently
- Strong strategic and analytical thinking, problem solving and rapid decision-making skills.
- Problem solving and project management ability, as well as lean manufacturing experience is essential.
- 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 an annual bonus, pension contribution, family medical allowance, 23.5 days annual leave plus 3 Company days, life assurance, on-site gym and gain-sharing bonus.
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Principal Scientist, Sterile Drug Product Technical Transfer (Manufacturing, Science & Technology)
locations Cruiserath - IE time type Full time posted on Posted YesterdayAbout Us
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