Bristol-Myers Squibb Company

Sr Associate, QC Operations

Location
Devens, MA, US
Posted
Dec 04, 2018
Ref
R1512174
Required Education
Bachelors Degree
Position Type
Full time
Responsibilities include but are not limited to:
1. Performs routine testing and data review of, in-process, batch release and stability samples of Bulk Drug Substance and Drug Product in a cGMP compliant environment.
2. Performs basic assays such as Appearance, UV-VIS Spectrometry, utility testing, (e.g. TOC), and some HPLC methodologies, (e.g. SEC CEX, and Poly-80)
3. Performs sample management including: sample receipt, processing, and distribution.
4. Writes and revises SOPs for managerial review and approval.
5. Aids in troubleshooting equipment and methods and performs some basic troubleshooting techniques.
6. Supports laboratory investigations

Qualifications:
• 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, pH, analytical balance, and HPLC.
• A working knowledge of regulatory standards as they apply to biopharmaceutical manufacturing

Contacts:
Sr. QC Chemistry Associates will work in teams and have continual interaction with members of his/her team as well as other teams throughout the facility in order to exchange information regarding testing completed, in process and planned.

Associates will have daily contact with her/his supervisory staff for work assignments, coaching and general management discussions.

Occasional contact with other line management staff relating to investigation support, or specific project responsibilities, may be expected.

Working Conditions:
Sr. Associates primarily work in a cGMP laboratory and follow techniques which require one to be alert, giving a high attention to detail, to properly use Personal Protective Equipment (PPE) and to handle hazardous materials.

Overtime work may be required on weekdays, weekends, holidays, and during adverse weather conditions in support of manufacturing facility.

Flexibility to work irregular hours and short notice overtime.