Senior Principal Scientist, Sterile Drug Product Technical Transfer

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.
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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 permanent Sterile Drug Product Technical TransferSenior Principal Scientist (Manufacturing, Science & Technology), position acts as a senior 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 a broad portfolio of complex products (new products and key lifecycle products) in the parenteral device network. 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 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.

• Lead / support multiple 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 across multiple formats.
• Performs Design of Experiments and Process Risk Assessment (FMEA) activities to establish appropriate process control strategies.
• As a subject matter expert will design, prepare, and review 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 co-author and approve key CMC sections as a subject matter expert. Shall be expert at writing formal reports/documents, technical presentations, articles for publication and scientific publications or patents.
• 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, so as to effectively lead a broad portfolio of complex projects within or across departments

Qualifications & Experience

• Highly advanced knowledge of the principles and concepts in the following areas: aseptic processing, sterilisation, sterile filtration, isolator technology, lyophilisation, vial and pre-filled syringe operations.
• In-depth knowledge of global regulatory requirements related to the design and control of these processes.
• In-depth Knowledge of SOPs, cGMPs and GLPs and the ability to work and manage within a regulatory environment.
• Demonstrated experience and Subject Matter Expert on the execution of technology transfer and scale up programs for commercial Drug Product manufacturing processes.
• Expert at Design of Experiments, Quality by Design, and Quality Risk Management concepts commonly employed in pharmaceutical manufacturing.
• In-depth experience with Technical Transfer of new processes is essential, as well as experience interacting with regulatory agencies.
• Demonstrated the design of highly complex projects or investigations, interpretation of very diverse data, and proactively recommended next steps and implications.
• 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 and has displayed an enterprise product mindset by challenging current approaches across a broad network.
• 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.

Why you should apply

• You will help patients in their fight against serious diseases
• You willbe part ofa 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.

If you come across a role that intrigues you but doesn't perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.
Uniquely Interesting Work, Life-changing Careers
With a single vision as inspiring as "Transforming patients' lives through science ", every BMS employee plays an integral role in work that goes far beyond ordinary. 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.
On-site Protocol
Physical presence at the BMS worksite or physical presence in the field is a necessary job function of this role, which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and it enhances the Company culture.
BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to . Visit eeo -accessibility to access our complete Equal Employment Opportunity statement.
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.
BMS will consider for employment qualified applicants with arrest and conviction records . click apply for full job details