Bristol-Myers Squibb is a global Biopharma company committed to a single mission: to discover, develop, and deliver innovative medicines focused on helping millions of patients around the world in disease areas such as oncology, cardiovascular, immunoscience and fibrosis.
Join us and make a difference. We hire the best people and provide them with a work environment that places a premium on diversity, integrity, collaboration and personal development. Through a culture of inclusion, we create a better, more productive work environment. We believe that the diverse experiences and perspectives of all our employees help to drive innovation and transformative business results.
This position is responsible for managing process microbial control for internal manufacturing sites and external manufacturing partners. The Process Microbiology group provides strategic technical leadership in drug substance and drug product manufacturing by driving alignment of functional groups and strategic teams across the Bristol-Myers Squibb Biologics network. The Process Microbiology team manages the process microbial control end-to-end (raw material to release specifications) for the global network by working closely with the teams responsible for the manufacturing of biologics clinical and commercial drug substance and drug product.
- Provide microbiology expertise to teams responsible for manufacturing biologics drug substance and drug product.
- Review and approve manufacturing documentation including Master Batch Records, Deviations, and Change Controls
- Prepare, review and approve technical reports
- Consult on microbiology related investigations
- Analyze and trend bioburden and endotoxin manufacturing data
- Author, review and/or approve microbiology control and QC method sections of regulatory filings
- Participate in responding to microbiology related health authority information requests
- Interact and advise internal manufacturing technical teams on microbiology related matters
- Drive relationships and interactions with Biologics External Manufacturing vendor's technical teams
- Participate on network teams to resolve microbiology-related issues, particularly those that impact multiple sites and products
- Prepare documentation and provide support for regulatory inspections and inspection readiness activities
- Provide support as Person in Plant microbiology SME observer of manufacturing operations
Specific Knowledge, Skills, Abilities, etc:
- Experience in sterile manufacturing drug product processes, with a strong knowledge of global regulatory requirements (e.g. FDA) related to control of the aseptic/environment aspects of these processes
- Demonstrated ability to take initiative, prioritize objectives from multiple projects, and to adhere to scheduled timelines while maintaining flexibility
- Provide microbiology scientific input to influence and support multidisciplinary teams
- Demonstrated problem solving ability, attention to detail, and analytical thinking
- Demonstrated knowledge of regulatory requirements and expectations including current issues and microbiology practices
- Knowledge of aseptic technique and microbiological testing including environmental monitoring, bioburden, bacterial endotoxin, microorganism identification, and various laboratory equipment, instrumentation, and techniques. Experience with quality control testing for drug product manufacturing is a plus
- Knowledge of good documentation practices, cGMP, and regulatory requirements
- Interpersonal, oral, and written communication skills are essential
- Must contribute to a team based, collaborative, and positive environment clarity of purpose and high commitment to business goals
- Working knowledge of Microsoft Office Applications (Access, Excel, Project, PowerPoint, Word) and/or other relevant software programs
- Experience in drug product manufacturing plant(s) with direct interaction regarding the environmental monitoring program, gowning practices, media fill program, and/or sterilization practices and aseptic technique.
- B.S. or M.S. in Microbiology, Biotechnology, Biology, or related sciences plus 4-8 years experience in the biopharmaceutical industry or equivalent combination of education and experience
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 the resources to pursue their goals, both at work and in their personal lives.