Bristol-Myers Squibb Company

Associate QC Scientist (Team Lead)

Devens, MA, US
Jul 10, 2018
Required Education
Bachelors Degree
Position Type
Full time

Individual will act as team lead for QC Microbiology area. Incumbent will be mentor to junior staff and point of contact for analyst in supervisor's absence.

Front room FDA/Inspectional experience on systems, QEs, method transfers etc.

  • Performs investigations for OOS, data analysis for method transfers and process investigations, assists in troubleshooting lab procedures and taking required corrective actions
  • Provide the technical expertise in support of method transfer/ validation activities for the QC network or for ongoing incoming, in-process, release and stability testing.
  • Ability to work across intra and inter functional departments to achieve alignment of company objectives.
  • Reviews or writes technical reports and perform data analysis and trending for both method transfers and investigations.
  • Recognize and troubleshooting of analytical/ microbiology method excursion. Provide guidance for equipment troubleshooting as needed.
  • Trains less experienced analysts on basic and complex test methods.
  • Peer review/ approval of lab data generated as a part of method transfer/ validation activities or for ongoing incoming, in-process, release and stability testing.
  • Becoming proficient to write technical reports/protocols and SOPs
  • Works according to cGMP requirements and HA expectations.

  • Knowledge of science generally attained through studies resulting in a BS/MS Degree or equiv. 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.
  • Proficiency (or mastery) of at least one discipline (cell based Bioassay, Immunoassay, Separation technology [chromatography], Bioburden and Endotoxin, Stability, trending, Investigation); technical knowledge/SME in a technical discipline
  • A thorough knowledge of cGMP regulations as referenced in The Code of Federal Regulations (21CFR) and their specific application to quality control laboratories in a biologics manufacturing facility.
  • Experience in interpreting and applying cGMPs, USP, regulatory requirements and industry best practices
  • Strong expertise in one or more disciplines, operational knowledge of analytical instruments to support ; familiar with method validations and procedures and method development history; proficient in lab software application such as LIMS, SmartLab, etc.
  • Knowledge of US/EU Requirements and industry best practices; develops strategies for solving complex problems/issues with coaching