Director, Biologics Analytical CMC Strategy

AbbVie; Massachusetts; On-site; USD 140,000 - 220,000; Full time

Benefits offered by this job

Paid time off

Medical/dental/vision insurance

401(k)

Long-term incentive programs

Job summary

AbbVie is seeking a senior leader for Biologics Analytical-CMC Strategy in the United States to guide late-stage development, method development, validation, and regulatory alignment for gene therapy and tLNP technologies. The role focuses on establishing robust analytical control strategies and enabling critical BLA activities.

You will coordinate cross-functional teams, drive project timelines, and communicate strategy and risks to stakeholders while supporting resource planning and

Qualifications

• Strategic thinker with strong analytical background in gene therapy and tLNP technologies.
• Experience in research and/or development environment.
• Proven ability to innovate with a history of new or improved product releases.
• Interacts well with diverse groups and maintains strong internal/external relationships.
• Ability to influence across scientific disciplines and balance stakeholder expectations.

Responsibilities

• Drives analytical control strategy, including specifications, CQAs, shelf-life, and risk-based comparability for the biologics pipeline.
• Establish collaborations across the organization to enable critical BLA activities.
• Set team strategies, manage resources, and define risk mitigation.
• Communicate project strategy, issues, and risks to teams and elevate cross-functional risks.
• Act as principal contact for stakeholders and balance expectations across functions.
• Participate in yearly FTE planning across the analytical organization.

Skills

Strategic thinking

Cross-functional collaboration

Communication

Project management

Analytical skills

Regulatory knowledge

Education

Bachelor’s degree in Science or related field

Master’s degree in Science or PharmD

PhD in Science or related field

Job description

AbbVie is seeking a senior leader for Biologics Analytical-CMC Strategy in the United States to guide late-stage development, method development, validation, and regulatory alignment for gene therapy and tLNP technologies. The role focuses on establishing robust analytical control strategies and enabling critical BLA activities.

You will coordinate cross-functional teams, drive project timelines, and communicate strategy and risks to stakeholders while supporting resource planning and