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.
Bristol-Myers Squibb has announced plans for an expansion of its large-scale biologics manufacturing facility in Devens, Massachusetts. The expansion will create a mammalian cell biologics center of excellence through the introduction of biologics development and clinical trial manufacturing capabilities to the site. Both represent new capabilities for Devens, a site that in its early years has focused solely on large-scale, bulk biologics manufacturing.
To perform QC analytical testing in support of biologics bulk drug substance manufacturing using defined methods in a cGMP compliant laboratory. Assures test results are accurately recorded and abnormal data or equipment/instrument malfunctions are promptly reported to his/her supervisor
1. Performs routine testing and data review of in-process, batch release and stability samples of Bulk Drug Substance in a cGMP compliant environment.
2. Participate in method transfer/ co-validation of HPLC methods (eg Peptide Mapping, SEC, Oligosaccharide Analysis), Electrophoresis (SDS-PAGE, CE-SDS, iCIEF etc), UV-VIS Spectrometry, utility testing
3. Writes and revises SOPs for managerial review and approval.
4. Performs broad range of troubleshooting techniques and leads such within area of expertise.
5. Trains less experienced analysts on basic and some more complex test methods.
• Knowledge of science generally attained through studies resulting in a B.S. in chemical sciences, a related discipline, or its equivalent.
• A minimum of 4 years experience in Biologics QC laboratory or related biopharmaceutical cGLP or cGMP lab.
• Strong detail orientation with strong general laboratory and good organizational skills
• Demonstrated ability to work independently as well as part of a team, to complete assignments within defined time constraints
• Ability to interpret and apply cGMPs, USP, regulatory requirements and industry best practices.
• Demonstrates leadership, problem solving and analytical thinking skills.
Bristol-Myers Squibb is an equal opportunity employer - Vet/Disability