Director, PDS&T Analytical CMC Development

Job overview

The Director, PDS&T Analytical CMC Development role is onsite in Worcester, MA; compensation is not specified. The role supports AbbVie’s Product Development Science and Technology Biologics Analytical-CMC Strategy team, which drives analytical control strategy for late-stage biologics development. AbbVie’s mission is to discover and deliver medicines and solutions for serious health issues. This director provides strategic and technical leadership for analytical control strategies across the biologics pipeline, helping ensure development and commercial readiness. The role coordinates cross-functional work, manages resources and risks, and communicates project strategy so analytical activities support regulatory submissions and product development goals.

What you'll do

• Drive analytical control strategy, including specifications, critical quality attributes, product shelf-life assessment, and risk-based comparability strategies
• establish collaborations to deliver critical analytical BLA-enabling activities
• set team strategies, manage resources, and define risk mitigation
• communicate project strategy, issues, and risks and facilitate resolution across functions
• serve as principal contact for stakeholders
• participate in annual FTE planning across the analytical organization.

What we're looking for

Skills & competencies

director

analytical cmc development

pds&t

worcester ma

abbvie

biologics

gene therapy

tlnp technologies

analytical control strategy

cmc

cross-functional leadership

bla-enabling activities

Work arrangement

• Weekend coverage required

Benefits & perks

• Eligible employees may receive paid time off, medical, dental and vision insurance, 401(k), and participation in long-term incentive programs.

Why this role

Technical focus includes gene therapy and tLNP technologies. Qualifications describe extensive related experience depending on degree: typically 18 years with a bachelor’s degree, 16 years with a master’s degree or PharmD, or 10 years with a PhD.

About the employer

AbbVie is hiring for this role. Industry: Research and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology). Sector: 54.