Bristol-Myers Squibb Company

QC Technical Support-Bioanalytical Associate Scientist

Location
Devens, MA, US
Posted
Jul 10, 2018
Ref
1R1503610
Required Education
Bachelors Degree
Position Type
Full time
The Quality Control Associate Scientist will lead or support the method technical transfer and/or validation activities for a cGMP biologics commercial and clinical manufacturing analytical laboratory. This role will act as a Subject Matter Expert (SME) for analytical methods such as ELISA, qPCR, and Biacore, providing technical support for the QC Operations Analytical Chemistry group. The role will require flexibility, high attention to detail, and a quality-driven mindset. This opportunity will allow the QC 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.
  • Troubleshoot QC analytical methods and equipment.
  • Review and approve QC analytical lab data.
  • Work independently to execute successful assay executions.
  • 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 Specrtramax, Biacore, and Quant Studio.
  • Proficiency in analytical methods such as ELISA, qPCR, and Biacore Binding.
  • Proficiency in software applications such as Softmax Pro, Trackwise, and LIMS.
  • Familiar with QC systems such as electronic notebooks and LIMS.
  • Develop training approach for new methods.
  • Develop and implement innovative, continuous improvement techniques.


Qualifications:

BS / MS or equivalent, preferably in Biological Sciences.

Minimum of 4 years (MS) / 6 years (BS) relevant experience in scientific QC methodologies, Biologics QC laboratory, or related biopharmaceutical cGLP or cGMP lab.