Senior Analytical Development Manager

1 week ago


Waltham, Massachusetts, United States AbbVie Full time

Company Overview

  • We are a leading biopharmaceutical company dedicated to developing innovative treatments for various diseases.

About the Role

This is an exciting opportunity to join our analytical development team as a Senior Analytical Development Manager or Lead Scientist for Antibody and ADC Methods. In this role, you will be responsible for supporting analytical method lifecycle activities at external AD/QC laboratories for late-phase antibody-drug conjugate (ADC) development. Your expertise will be crucial in managing antibody and ADC reference standard programs for all development phases.

Key responsibilities include validations, re-validations, transfers, continued performance verification, optimization, troubleshooting, and authoring documentation. You will also collaborate with QA to ensure GMP requirements are met and plan and execute laboratory experiments to support method optimization or troubleshooting.

In addition, you will serve as an analytical representative on the CMC team and perform statistical analysis of batch data to support specification setting and product comparability studies.

Requirements

  • A BS, MS, or equivalent education in chemistry, biochemistry, or a related discipline
  • At least 7 (BS) or 5 (MS) years' experience in analytical development or quality control, mostly supporting antibody or ADC therapeutics under GMP
  • Experience with analytical separation methods (HPLC, CE, etc.)
  • Experience with analytical method lifecycle management (validations, transfers, CPV, etc.)
  • Experience with large-molecule reference standard management
  • Strong knowledge of GMP requirements, ICH guidelines, and compendia (USP and Ph. Eur.)
  • Experience working with third-party laboratories preferred

What We Offer

  • An estimated salary range of $120,000 - $180,000 per annum
  • A comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance, and 401(k) to eligible employees
  • This job is eligible to participate in our short-term incentive programs

EEO Statement

  • We are an equal opportunity employer committed to operating with integrity, driving innovation, transforming lives, serving our community, and embracing diversity and inclusion


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