Bristol Myers Squibb Company

Specialist, QC Operations STAT Team

Devens, MA, United States
Aug 09, 2019
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.

Job Description:
  • Performs routine testing and data review of in-process and batch release samples of Bulk Drug Substance in a cGMP compliant environment.
  • Performs routine assays such as UV-VIS Spectrometry, Titer, utility testing, personnel and environmental monitoring, Total Organic Carbon testing, and more complex assays including various HPLC methodologies (e.g. sialic acid).
  • Write and revise SOPs for managerial review and approval.
  • Performs broad range of troubleshooting techniques and leads such within area of expertise.
  • Trains less experienced analysts on basic and some more complex test methods.

*Works on a 12 hour (5AM to 5PM)rotating shift 36/48. Required to work every other weekend, any holiday that falls on their scheduled shift, and during adverse weather conditions in support of manufacturing facility. Flexibility to work irregular hours and short notice overtime.

Required Experience:
  • 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 UV/Vis, HPLC, Titer, and TOC.
  • Excellent manual dexterity including proficiency in aseptic techniques.
  • 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 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.
  • All QC 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 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.
  • 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. This is a 12 hour rotating shift (5am-5pm)
  • 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.
  • Specialist will be expected to participate in the training of less experienced staff in normal operational tasks.

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.