Manager - Upstream MSAT
- Lead and develop a team of Upstream scientists and engineers provide technical support and routine process monitoring for commercial products manufactured at CMOs.
- Provide person-in-plant support of manufacturing operations at CMOs and communicates observations to the product team.
- Work closely with CMO MSAT, oversee and report on overall manufacturing progress.
- Review manufacturing batch records, production data, deviations, and protocols/reports.
- Become SMEs of manufacturing processes, by reviewing process descriptions, development reports, control strategies, etc.
- Provide technical support and data analysis for investigations and deviation resolution.
- Work collaboratively with MSAT Process Science team, recommend changes and/or study plan to improve process robustness and yield.
- Interact with internal and external partners such as other functions in MSAT, External Manufacturing & Supply operation, Engineering, and Quality.
- Support tech transfer, facility fit assessments, and process validation activities at CMOs.
- Support regulatory filings and inspections for the processes manufactured at CMOs.
- Manage resource planning and prioritization of activities, oversight of delivering on commitments in respective areas.
- Coach and develop the team - mentor and develop each member both in execution of responsibilities and in personal development. Establish a high-performance team that fosters accountability, open communication, people development and continuous improvement.
- Bachelor’s degree with 9 years, or Master’s degree with 7 years, or PhD with 5 years in industrially relevant biologics development, bioprocess engineering, technology transfer and/or commercial manufacturing operations
- Excellent scientific and engineering background, technical writing, and presentation skills
- Experience in managing, coaching, and developing scientific and engineering staff or leading matrix managed teams
- Experience with Good Manufacturing Practices and supporting commercial manufacturing operations
- Experience with advanced process monitoring, data analysis, and CPV
- Experience with change assessment, product impact assessment, and quality event management
- Hands-on experience with mammalian cell culture operations at laboratory, pilot, or manufacturing scale
- Experience with upstream process development / characterization, technology transfers, PPQ, and process control strategy establishment
- Experience with authoring regulatory filings and supporting PAI and other health authority inspections.
- Highly motivated individual with the ability to influence cross-functional and cross-site teams and to effectively communicate with project leaders and department and site management
- Flexible with ability to adjust to a fast-paced, goal-oriented environment and willingness to expand and broaden skillset.
- English
- Bring the miracles of science to life alongside a supportive, future-focused team.
- Discover endless opportunities to grow your talent and drive your career, whether it’s through a promotion or lateral move, at home or internationally.
- Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.
- Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks’ gender-neutral parental leave.
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