Director, Biologics Analytical CMC Strategy

Biopharma Careers; Maryland; On-site; USD 180,000 - 240,000; 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 scientist to lead analytical CMC strategy for biologics, driving late-stage development and commercial readiness. The role requires cross-functional collaboration with process development, regulatory, and quality teams to ensure robust strategy and timely execution.

The candidate will influence across disciplines, manage complex projects, and participate in annual planning. A strong technical background in biologics, gene therapy, or related technologies is essential.

Qualifications

• Bachelor’s Degree or higher in science with extensive related work experience.
• Experience in research and/or development environments.
• Proven ability to innovate with a history of new or improved product releases.
• Interacts well with diverse groups within function and maintains strong working relationships with internal and external collaborators.

Responsibilities

• Drives overall analytical control strategy for biologics.
• Establishes collaborations to enable BLA activities across the org.
• Sets team strategies, manages resources and risk mitigation.
• Communicates strategy, issues and risks to stakeholders across functions.
• Acts as principal contact for stakeholders and balances expectations.
• Participates in yearly FTE planning for the analytical organization.

Skills

Strategic analytical thinking

Cross-functional collaboration

Project management

Regulatory awareness

Education

Bachelor’s Degree or higher in science

Master’s Degree, PharmD or PhD with extensive related work

PhD in Science or related field

Job description

AbbVie is seeking a senior scientist to lead analytical CMC strategy for biologics, driving late-stage development and commercial readiness. The role requires cross-functional collaboration with process development, regulatory, and quality teams to ensure robust strategy and timely execution.

The candidate will influence across disciplines, manage complex projects, and participate in annual planning. A strong technical background in biologics, gene therapy, or related technologies is essential.