Principal Scientist, Cell Culture Ms&T

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Position Summary:
The role of Principal Scientist in the BioProcess Technology (BPT) function of MS&T, Cell Culture is to serve as the technical lead to support commercial drug substance Cell Culture activities at the Devens large-scale Cell Culture (LSCC) facility, Devens single-use facility (SUF) and external manufacturing (ExM) sites. The position will be highly cross-functional and will build and maintain effective collaborations with Manufacturing, Manufacturing Technology/Sciences, Process Engineering, Digital Plant/Automation, Quality Assurance, Analytical, and Global Regulatory Sciences groups. This role will report to the Associate Director of the Cell Culture group of BPT and is part of the BPT extended leadership team.
Key Responsibilities:

• Design and execute analysis of media, cell banking, seed train, and bioreactor experiments using scale-down models and the interpretation of these results with respect to the GMP manufacturing process
• Interface with site functions for joint accountability for manufacturing of drug substance at the Devens LSCC, Devens SUF, and External Manufacturing
• Lead and/or support process technology transfers, process validation, and the preparation of CMC documentation for regulatory filings. Cell culture SME for health authority questions and audits.
• Lead and/or support manufacturing process changes and investigations and maintain in depth understanding of manufacturing data
• Own preparation of protocol studies and reports to support GMP manufacturing activities
• Lead evaluation and implementation of new process technologies using scale-down models
• Manager of multiple direct reports including FTE, contract staff, and co-ops
• Embody the BMS behaviors and serve as a leader and role model within BPT and the drug substance MS&T organization

Qualifications & Experience:

• BSc in STEM field with 8+ years' experience (e.g. chemical engineering, biology, or equivalent)
• MS or PhD is preferred, time spend in advanced degree programs may be considered as equivalent to relevant experience
• 4+ years' experience in biopharmaceutical industry or a similar, highly regulated industry
• A strong practical knowledge of the technologies related to Cell Culture and bioprocess engineering
• Experience with cGMP regulations, regulatory requirements and CMC authoring for biologics manufacturing are necessary
• Experience in contributing to the design, modification and optimization of Cell Culture or fermentation unit operations
• Interest in assessing scientific technologies and their application to the BioPharma industry
• Demonstrated success in matrix leadership, project management, and/or people leadership
• Demonstrated effectiveness in both a team environment and as an individual contributor with minimal supervision
• Organizes and presents data for internal/external scientific meetings
• Occasional business travel may be required (up to 10%)

#LI-Hybrid
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 adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.
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