Bristol Myers Squibb Company

QC Bioseparations Associate Scientist

Location
Devens, MA, United States
Posted
Sep 02, 2020
Ref
R1529328
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.

The Quality Control Bioseparations Associate Scientist will support the lab supervisor with the day-to-day release and stability testing within the bioseparations labs. This role will lead or support the method technical transfer and/or validation activities for a cGMP biologics commercial and clinical manufacturing analytical laboratory and will act as a Subject Matter Expert (SME) for analytical methods such as HPLC, UPLC, Capillary Electrophoresis (CE), iCIEF, and SDS-PAGE, providing technical support for the lab analyst. The role will require flexibility, high attention to detail, and a quality-driven mindset. This opportunity will allow the QC Bioseparations Associate Scientist to become a member of diverse project teams across a global, matrix organization.

Job Description:

The Quality Control Bioseparations Associate Scientist will support the lab supervisor with the day-to-day release and stability testing within the bioseparations labs. This role will lead or support the method technical transfer and/or validation activities for a cGMP biologics commercial and clinical manufacturing analytical laboratory and will act as a Subject Matter Expert (SME) for analytical methods such as HPLC, UPLC, Capillary Electrophoresis (CE), iCIEF, and SDS-PAGE, providing technical support for the lab analyst. The role will require flexibility, high attention to detail, and a quality-driven mindset. This opportunity will allow the QC Bioseparations Associate Scientist to become a member of diverse project teams across a global, matrix organization.

Responsibilities and Requirements include:
  • Author and review technical documents such as technical transfer protocols and reports.
  • Support multi-site method transfer and validation projects.
  • Troubleshoot QC analytical methods and equipment.
  • Review and approve QC analytical lab data.
  • Execute release and stability testing in the QC bioseparations lab, as needed.
  • Develop training approach for new methods.
  • Develop and implement innovative, continuous improvement techniques.
  • Ability to recognize anomalous trends or results.
  • Ability to quickly adapt to change and adjust tasks in order to reach shared business goals or timelines.
  • Knowledge in QC analytical equipment qualifications (IQOQPQ) and decommissioning.
  • Front room regulatory agency (FDA, EMA) inspection involvement.
  • Knowledge in cGMP regulations as referenced in The Code of Federal Regulations.
  • Provide technical support for CAPAs, lab investigations, out of trend alerts, and OOS results for QC analytical methods.
  • Experience using equipment such as HPLC, UPLC, Capillary Electrophoresis (CE), Charged Aerosol Detector (CAD) spectrophotometer.
  • Proficiency in analytical methods such as SEC, Reversed Phase, Cation Exchange, N-linked Oligosaccharides, Peptide Mapping, iCIEF, and SDS-PAGE.
  • Proficiency in software applications such as Empower3, Trackwise, 32Karat, and LIMS.
  • Familiar with QC systems such as electronic notebooks and LIMS.


Qualifications:

BS / MS or equivalent, preferably in Analytical Chemistry or related discipline.

Minimum of4 years (MS) /6 years (BS) relevant experience in scientific QC methodologies, Biologics QC laboratory, or related biopharmaceutical cGLP or cGMP lab.

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.