Bristol-Myers Squibb Company

Associate QC Scientist

Location
Devens, MA, US
Posted
May 12, 2018
Ref
R1503610
Required Education
Bachelors Degree
Position Type
Full time
Responsibilities:
- Lead and participate in method transfer and validation activities across the network including protocol and report review, execution, and troubleshooting.
- Peer review and communication of lab data in a concise, organized, and compliant manner.
- Support critical reagent and Reference Material programs as well as routine testing in a cGMP compliant environment for the following methodologies: Bioassay, ELISA, Biacore, and qPCR.
- Support health authority inspections
- Author SOPs and training documents
- Perform in depth historical data analysis to support investigations, method performance monitoring, and method transfers.
- Execute equipment troubleshooting to support method performance and enhancement.
- Perform instrument qualifications
- Train and assist less experienced scientists within area of expertise

Qualifications:
-A theoretical understanding of biology with a B.S. in biological sciences, a related discipline, or equivalent.
-Proficiency or mastery in Bioassay or ELISA with strong technical knowledge of qPCR.
-A minimum of 4 years (MS) or 6 years (BS) relative experience in the listed scientific QC methodologies, Biologics QC laboratory, or related biopharmaceutical cGLP or cGMP lab.
-Strong expertise in operational knowledge of analytical instruments and method validations
-A thorough knowledge of cGMP regulations as referenced in The Code of Federal Regulations (21CFR) and their specific application to quality control laboratories in a biologics manufacturing facility.
- Strong problem solving ability, interpersonal, oral and written communication skills.
-Ability to prioritize objectives from multiple projects, adhere to scheduled timelines while maintaining flexibility and attention to detail.
-Contribute to a team based, collaborative, and positive environment, with clarity of purpose and a high commitment to business goals.