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Position Summary This individual is accountable to establish microbial control strategies for sterile drug product manufacturing environments for the internal BMS drug product manufacturing network, with the primary focus on the BMS site in Manati, Puerto Rico (MTI). Approximately 80% of the work scope will be focused on supporting the MTI site. This role may also have engagement with external drug product manufacturing partners throughout the US, Europe and Asia.
The aseptic processing SME will partner with the Manati manufacturing site 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 / Parenterals team as well as the Microbiology CoE Testing group. It is expected that this role will also engage with industry forums such as PDA, BPOG, and ISPE.
Position Responsibilities: Provide oversight to the BMS Manati site media fill program, 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 new areas for internal sites. Provide oversight to the BMS Manati site gowning practices and environmental monitoring programs employed to ensure establishment and verification of maintenance of the aseptic processing environment. Provide oversight/input to BMS Manati site sterilization process qualification activities, and review and approve PQ protocols. Support Tech Transfer activities as needed. May act as SME for external sites within the BMS network. Leadership and/or support of critical manufacturing investigations involving aseptic processing components, including root cause analysis, CAPA generation, and impact assessment. May act as SME for external sites within the BMS network. Act as the point of contact to triage microbial investigations to the appropriate microbiology SME within 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. Interface with the Biologics Drug Product MS&T group and product specific technical teams to consult on microbial sampling during technology transfers and qualification activities. Participation in site assessments/vendor selection for CMOs/vendor with Procurement, MS&T, Quality, and other business functions. May act as 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.
Desired Experience: Education: 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.
Experience / Knowledge Desired: 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 10-15% 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
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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.
Physical presence at the BMS worksite or physical presence in the field is an essential job function of this role which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and enhances the Company culture.
To protect the safety of our workforce, customers, patients and communities, the policy of the Company requires all employees and workers in the U.S. and Puerto Rico to be fully vaccinated against COVID-19, unless they have received an exception based on an approved request for a medical or religious reasonable accommodation. Therefore, all BMS applicants seeking a role located in the U.S. and Puerto Rico must confirm that they have already received or are willing to receive the full COVID-19 vaccination by their start date as a qualification of the role and condition of employment. This requirement is subject to state and local law restrictions and may not be applicable to employees working in certain jurisdictions such as Montana. This requirement is also subject to discussions with collective bargaining representatives in the U.S.
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