Bristol-Myers Squibb Company

Specialist, QC Release and Stability

Location
Devens, MA, United States
Posted
Aug 09, 2019
Ref
R1517049
Required Education
Bachelors Degree
Position Type
Full time
Bristol-Myers Squibb is a global Biopharma company committed to a single mission: to discover, develop, and deliver innovative medicines focused on helping millions of patients around the world in disease areas such as oncology, cardiovascular, immunoscience and fibrosis.

Join us and make a difference. We hire the best people and provide them with a work environment that places a premium on diversity, integrity, collaboration and personal development. Through a culture of inclusion, we create a better, more productive work environment. We believe that the diverse experiences and perspectives of all our employees help to drive innovation and transformative business results.

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.

~Performs cell based bioassay.
~Writes and revises SOPs for managerial review and approval.
~Performs broad range of troubleshooting techniques and leads such within area of expertise.
~Supports/Leads Laboratory investigations
~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 is required.
• A minimum of 4 years experience in Biologics QC laboratory or related biopharmaceutical cGLP or cGMP lab.
• Experience in analytical test methods such as Bioassay and ELISA
• 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.

QC Chemistry Specialists 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.

Specialists 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.

Specialists 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.

Specialists should be observant of their work area and related tools and identify and report any discrepancy from normal practice or procedure, recommending corrective action.

Incumbents normally receive general instructions on routine work and general instructions on new assignments.

No direct supervision, but the Specialist will be expected to participate in the training of less experienced staff in normal operational tasks.

*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.

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.