Sr Associate, QC Operations
About the Job
At Bristol-Myers Squibb, we believe that together we can make the difference. We want to do this by building professional teams who can create and innovate medicines that benefit doctors and their patients.
Our large-scale biologics manufacturing facility in Devens, Massachusetts, is expanding and there are a number of exciting career opportunities to join Bristol-Myers Squibb, one of the world’s leading BioPharma companies.
We’ve created one of the world’s premier biologics facilities, among the first sites in the industry to have a fully automated, integrated manufacturing control system that enables the plant to run virtually paperless. It is a site that combines biologics development with clinical and commercial manufacturing on a single campus – a true biologics center of excellence for the company where teams are encouraged to closely collaborate. This expansion was designed to support the launch of new medicines by more closely aligning biologics development and manufacturing capabilities. All this goes towards helping create and innovate life-saving medicines that fight serious illnesses.
This is a 3rd shift position that supports STAT and routine chemistry and microbiology testing.
Responsibilities include but are not limited to\:
- Performs routine testing and data review of raw materials samples, in-process, batch release and stability samples of Bulk Drug Substance in a cGMP compliant environment.
- Performs routine assays such as UV-VIS Spectrometry, SDS Page, Wet chemical analysis, various HPLC methodologies (e.g. SEC and reverse phase), utility testing (e.g. TOC, conductivity, endotoxin, bioburden and gas testing.), in process endotoxin/bioburden testing, personnel monitoring and routine environmental monitoring.
- Performs sample management including\: sample receipt, sample tracking, aliquots preparation, and sample distribution
- Recognize, report and document deviations from test methods, specifications and alert/action limits.
- Writes and revises SOPs for managerial review and approval.
- Aids in troubleshooting equipment and methods and performs some basic troubleshooting techniques.
- Trains less experienced analysts on routine test methods
- Knowledge of science generally attained through studies resulting in a B.S. in chemical sciences, a related discipline, or its equivalent is required.
- A minimum of 2 years relevant experience in Biologics QC laboratory or related biopharmaceutical cGLP or cGMP lab.
- Good functional experience with common laboratory tools and equipment such as\: UV-VIS Spectrometry, electrophoresis, Wet chemical instrumentation, HPLC, endotoxin and environmental monitoring.
- Highly detail oriented with strong general laboratory skills and good organizational skills.
- Demonstrated ability to work independently as well as part of a team, to complete assignments within defined time constraints.
- A working knowledge of regulatory standards as they apply to biopharmaceutical manufacturing.
This position is M-F 11pm to 7am (3rd shift), subject to change upon business needs. Overtime work may be required on weekdays, weekends, holidays, and during adverse weather conditions in support of manufacturing facility.
Together, we make a difference. Bristol-Myers Squibb is one of the world’s BioPharma leaders, committed to delivering innovative medicines as well as nurturing a culture that’s a springboard for progress. Our success depends on building teams of bold, innovative and passionate employees who will help continue to drive us further forward. No matter the role, we are united by our mission and determined to win this fight. And that makes all the difference. If you want to join us, apply now at www.bms.com/careers.