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Job

Senior Manager/Associate Director Preclinical R&D and Bioanalytics

  • Location

    Massachusetts

  • Sector:

    Life Sciences

  • Job type:

    Permanent

  • Salary:

    130k-200k

  • Contact:

    Tim Viola

  • Contact email:

    t.viola@hamlynwilliams.com

  • Salary high:

    0

  • Salary low:

    0

  • Published:

    about 1 month ago

  • Expiry date:

    2021-12-01

  • Startdate:

    ASAP

Title: Senior Manager/Associate Director Preclinical R&D and Bioanalytics

5 days a week in office

Salary: Dependent upon title, but slated for 130k-200k

Responsibilities: 

  • Manage a team of bioanalytical scientists
  • Guide the development, optimization, and validation of immunoassays (e.g., ELISA, MSD) under non-GLP and GLP (Good Laboratory Practice) to support my client's pipeline.
  • Work closely with analysts, senior management, and Quality Assurance to ensure timely delivery of nonclinical and clinical results.
  • Review data per GLPs, prepare data transfers, and write reports to be included as part of regulatory submissions.
  • Work closely with Quality Assurance group to schedule lab, data, and report audits.
  • Track and ensure the resolution of CAPAs.
  • Follow established protocols; author, revise, and review method SOPs.
  • Data analysis and presentation of data.

Required skills:

  • Management experienced highly preferred
  • Knowledge and application of regulatory guidance (GLP preferred) to experimental planning and design.
  • Experience in immunoassay development, with particular experience in developing, optimizing, and validating PK and ADA assays using animal/human samples according to FDA guidance documents.
  • GLP (21 CFR Part 11 and Part 58) experience and validation
  • Experience in writing and reviewing analytical SOPs, study protocols, and reports.
  • Experience in the aseptic maintenance of cell lines in culture a plus.
  • Experience in flow cytometry a plus.

Education/Experience:

  • BS/BA degree in Biology or a similar discipline
  • 5+ years of Biotech industry experience in a regulated environment.

 

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