Principle Scientist, Aseptic and Microbial Process Control Sciences

at  BristolMyers Squibb

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.

QUALIFICATIONS, KNOWLEDGE AND SKILLS REQUIRED:

• Bachelor’s degree or equivalent in relevant engineering or scientific discipline with a minimum of 10 years of relevant experience. Masters or PhD is preferred (but not required). Time spent in advanced degree programs may be considered as equivalent relevant experience.
• Subject matter expert in sterile manufacturing processes and technology, and aseptic processing.
• Strong knowledge of global regulatory requirements (e.g. FDA) related to the design and control of the aseptic/environmental aspects of these processes.
• Knowledge of SOPs, cGMPs and GLPs and the know how to work and manage within a regulatory environment.
• Experience in sterile manufacturing plant(s) with interaction regarding the environmental monitoring program, gowning practices, media fill program, and/or sterilization practices and aseptic technique.
• Working knowledge of microbiological testing including environmental monitoring, bioburden, bacterial endotoxin, sterility, microorganism identification, and various laboratory equipment, instrumentation, and techniques is a plus.
• Strong technical writing skills.
• Demonstrated strong oral and written communication skills, along with demonstrated project management experience.
• Familiarity with Design of Experiments, Quality by Design, and Risk Assessment concepts commonly employed in pharmaceutical process development
• Experience with formal risk assessment and investigational tools such as pFMEA, Ishikawa Fish Bone,
• Requires approximately 20% travel
• Demonstrated ability to:
• Influence areas not under direct control to achieve objectives
• Work strategically, manage multiple programs consistent with department objectives
• Work well in a matrix environment and effectively support the decentralized manufacturing function
• Build alignment with business partners including the manufacturing sites, the Micro CoE Testing group Quality stakeholders
• Manage risk and make rapid decisions
• Strong strategic and analytical thinking, problem solving and rapid decision making skills
• Demonstrated capability in implementing challenging goals, objectives and practices in a complex and ambiguous/matrix environment
• Strong ability in negotiating and influencing without authority in complex, high impact situations
• Strong presentation and communication skills both, oral and written

THE ROLE

Bristol Myers Squibb is looking to recruit a permanent contract Principle Scientist, Aseptic and Microbial Process Control Sciences to join our team in Dublin.
This individual is accountable to establish microbial control strategies for sterile drug product manufacturing environments for the internal and external BMS drug product manufacturing network.
The aseptic processing SME will partner with the internal and external manufacturing sites to define strategies for microbial control for DP related manufacturing activities such as gowning, environmental monitoring, media fill program, and will ensure the control strategies comply with Annex 1 and FDA Guidance for Industry.
The individual will interface with the manufacturing plant to support the establishment and maintenance of critical cGMP aseptic activities, and will also support critical manufacturing investigations involving aseptic processing.
This role will closely collaborate with the MS&T Biologics Drug Product / Parenteral team as well as the Microbiology CoE Analytical group. It is expected that this role will also engage with industry forums such as PDA, BPOG, and ISPE. Direct Reports None Business Partners & Interactions
The Aseptic Processing SME influences and maintains effective collaborations across the BMS network, closely partnering with MS&T Parenteral, Quality, QC, Manufacturing, network Microbiology CoE Analytical, as well as other MS&T partner functions.
This role will interact with Health Authorities.
Based on your function, department or individual position, you will have the opportunity to discuss with your Manager the option to work remotely up to 50% of the time, over a two-week period, with the flexibility to choose the days that align with your collaboration needs

KEY DUTIES AND RESPONSIBILITIES:

• Establish microbial control strategies for sterile drug product manufacturing environments for the internal and external BMS drug product manufacturing network.
• Provide oversight to site media fill programs, including elements such as required operator training and qualification, approach to coverage of all products in the media fill program, use of components, and intervention strategy. Review and approve annual media fill programs and aseptic validation master plans for internal & external sterile DP manufacturing sites.
• Provide oversight to site gowning practices and environmental monitoring programs employed to ensure establishment and verification of maintenance of the aseptic processing environment
• Provide oversight/input to site sterilization process qualification activities, and review and approve PQ protocols. Support Tech Transfer activities as needed.
• Leadership and/or support of critical manufacturing investigations involving aseptic processing components, including root cause analysis, CAPA generation, and impact assessment. Act as the point of contact to triage microbial investigations and collaborate on resolution with microbiology SMEs across the network.
• Collaborate with the Microbiology CoE Testing group, with the aim to provide process support/expertise to rapid microbiology method development and implementation in the production environment.
• Support Tech Transfers and interface with the Biologics MS&T Drug Product / sterile parenteral group, site manufacturing, and product specific technical teams to align on microbial sampling strategies.
• Participation in site assessments/vendor selection for CMOs/vendor with Procurement, MS&T, Quality, and other business functions. Technical SME on Quality audit team for External manufacturing sites.
• Interface with industry consortiums such as BPOG, ISPE, PDA to maintain a view of the current trends and best practices for aseptic processing.
• Technical input, authoring (when applicable), and approval of CMC documents for process validation P.3.5 sections.
• Support CMC queries and resolution with Global Health Authorities, and support plant inspections.