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Director, PDS&T Analytical CMC Development

BioSpace · Worcester, MA, USA ·

Pay:
100.000
Job type:
Full Time

Job Description

Abbvie Product Development Science and Technology (PDS&T) Biologics Analytical‑CMC Strategy team is responsible for driving the analytical CMC control strategy for late‑stage development of biologics. The role requires a strategic thinker with a strong technical analytical background in gene therapy and tLNP technologies, able to manage complex projects and communicate cross‑functionally.

Responsibilities

  • Drive overall analytical control strategy, including justifying specifications, determining critical quality attributes, assessing product shelf‑life, and implementing risk‑based comparability strategies for the biologics pipeline.
  • Establish cross‑functional collaborations to ensure delivery of critical analytical BLA enabling activities.
  • Set team strategies, manage resources, and define risk‑mitigation plans.
  • Communicate project strategy, key issues, and risks to relevant teams and facilitate resolution.
  • Act as principal contact for stakeholders and balance conflicting expectations across functions.
  • Participate in yearly FTE planning across the analytical organization.

Qualifications

  • Bachelor’s degree or equivalent in a science‑related field, or Master’s/PhD with appropriate years of related work experience.
  • Experience in a research and/or development environment.
  • Proven ability to innovate with a history of new or improved product releases.
  • Strong interpersonal skills and ability to influence across scientific disciplines.
  • Technical background in healthcare, laboratory diagnostics, medical devices, or pharmaceutical companies.

Benefits

  • Competitive base‑pay range (details provided in posting).
  • Comprehensive benefits package: paid time off, medical, dental, vision insurance, and 401(k) for eligible employees.
  • Eligibility to participate in long‑term incentive programs.

Equal Opportunity Statement

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer / Veterans / Disabled.

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