Bristol Myers Squibb D4 - Associate Scientist in Devens, Massachusetts

Responsibilities:

  • 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 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 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 release and stability testing.

Qualifications:

  • 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 Separation technology [chromatography], 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

Bristol-Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.