Scientist/Engineer, Downstream MS&T – Bristol-Myers Squibb – Syracuse, NY, USA
Bristol-Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases.
One shared journey is moving us forward at Bristol-Myers Squibb. Around the world, we are passionate about making an impact on the lives of patients with serious disease. Empowered to apply our individual talents and ideas so that we can learn and grow together. And driven to make a difference, from innovative research to hands-on community support. 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.
The Syracuse Biologics Manufacturing operation produces clinical, commercial and launch biologics drug substance at its 5000L scale manufacturing facility (mammalian cell process) in Syracuse, NY
The role of the Scientist/Engineer is to conduct experiments and lead activities for the purposes of commercial support for downstream biopharmaceutical manufacturing. The candidate will support ultrafiltration/diafiltration, filtration, bulk fill, freezing, storage and cold chain shipping operations for biologics drug substance. The candidate will conduct investigations to define in-process control strategies for bulk fill, freezing and storage and contribute towards the development of novel methodologies to enhance our current understanding of biologics bulk drug substance freezing.
Responsibilities include but are not limited to:
- Experimental design and analysis of results, data verification, preparation of study protocols and final reports, and the presentation of findings at internal and external forums.
- Support of the technical transfer of manufacturing processes internally and externally and troubleshooting process‑related problems observed at manufacturing scale through the effective design of scale-down studies and the evaluation of data from manufacturing lots.
- Appropriate GLP/GMP procedures must be followed.
- CMC authoring for regulatory interactions/filings (BLA, MAA, PAS, etc.) is a responsibility of this position.
- Work effectively in cross-functional project teams and independently to accomplish project goals.
- Lead project teams and personnel as well as interface with Process Development, Pilot Plant, Manufacturing, Supply Chain, Quality Assurance, Analytical, and Global Regulatory Sciences groups.
Qualifications
Qualifications:
- Ph.D. or M.S. degree in Pharmaceutical Sciences, Biological or Chemical Sciences/Engineering or related disciplines and the following lengths of relevant experience: Ph.D. 0 to 4 years, M.S. 4 to 6+ years.
- In-depth understanding of protein freezing/thawing, formulation and stability is required.
- Knowledge of common protein analytical tools and demonstrated experimental skills for lab work are required.
- Ultrafiltration/diafiltration, filtration, process development, characterization, and/or validation experience are desired.
- Knowledge of chromatography operations is beneficial.
- Candidates must possess good organizational skills and strong attention to details, excellent experimental/troubleshooting aptitude, and be self motivated.
- Experience with statistical methodologies, cGMP regulations, regulatory requirements, and CMC authoring for biologics processes are a plus.
The candidate should also possess good verbal and written communication skills, as well as excellent interpersonal skills with the ability to work in a team environment
Bristol-Myers Squibb is an equal opportunity employer – M/F/Vet/Disability
Requisition ID – 1501409
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