QC Senior Associate - Bioseparations

Devens, MA, United States
Sep 24, 2020
Quality, Quality Control
Required Education
Bachelors Degree
Position Type
Full time
At Bristol Myers Squibb, we are inspired by a single vision - transforming patients' lives through science.In oncology, hematology, immunology and cardiovascular disease - and one of the most diverse and promising pipelines in the industry - each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.

Major Duties and Responsibilities
  • Perform routine testing and data review of in-process, batch release, and/or stability samples of Bulk Drug Substance in a cGMP compliant Bioseparations laboratory.
  • Executes routine procedures based on methodologies/responsibilities of the QC Bioseparations team. Methodologies include iCIEF, Capillary Electrophoresis (CE), Gel Electrophoresis, and HPLC/UPLC. Assignments are made in the LIMS, by the hiring manager, based on applicable curricula map(s).
  • May author revisions to SOPs for managerial review and approval.
  • Train on additional methodologies, and provides support to a broader spectrum of testing responsibilities.
  • Support investigations through data gathering or interview process.

    Knowledge and Skill
  • Knowledge of science generally attained through studies resulting in a BS in the physical or life sciences, a related discipline, or the equivalent in related experience.
  • A minimum of 2 years relevant experience in a cGMP Biologics QC laboratory or equivalent in related laboratory environment.
  • Demonstrated experience with basic laboratory techniques such as pH, volumetric measurement, pipetting, analytical weighing, and basic laboratory safety practices.
  • Prior experience in HPLC/UPLC, SDS-PAGE, iCIEF, and Capillary Electrophoresis (CE) is preferred.
  • A working knowledge of regulatory standards as they apply to GMP laboratories.
  • Attention to detail and demonstrated organizational skills.
  • Demonstrated manual dexterity.
  • Knowledge of basic electronic systems (email, MS Office, etc.)
  • Experience with LIMS and ELN computer applications a plus.

  • Will work in teams and have continual interaction with members of his/her team as well as other sub-teams within QC, in order to exchange information regarding testing completed, in process and planned.
  • Daily contact with her/his supervisory staff for work assignments. Routine contact with supervisor for coaching and general performance management discussions.
  • Occasional contact with other line management staff relating to specific project responsibilities may be expected.

Working Conditions
  • 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.

Decision Making
  • Sr. Associates should be observant of their work area and related tools and identify and report any discrepancy from normal practice or procedure.
  • Incumbents normally receive detailed instructions on routine work and detailed instructions on new assignments.

Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

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 with the resources to pursue their goals, both at work and in their personal lives.