Biologics Analytical CMC Strategy Lead

AbbVie Inc.; Worcester (MA); On-site; USD 180,000 - 240,000; Full time

Benefits offered by this job

Medical/dental/vision insurance

401(k) plan

Job summary

AbbVie is seeking a senior leader for Biologics Analytical-CMC Strategy within PDS&T to drive analytical control strategies for late-stage biologics. You will partner cross-functionally with process development, regulatory, and quality to enable regulatory submissions and robust method development.

The role calls for a strategic thinker with extensive industry experience in gene therapy and tLNP technologies, a track record of scientific innovation, and the ability to steer complex projects

Qualifications

• Bachelor’s Degree or equivalent education in Science related field with extensive (typically 18 years) of related work; Master’s Degree or equivalent education Science or PharmD or equivalent education with extensive (typically 16 years) of related work; PhD in Science or related field with typically 10 years of related work experience.
• 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 within function and maintains strong working relationships with internal and external collaborators.
• Demonstrated ability to influence others across areas of scientific disciplines.
• Technical background in healthcare, laboratory diagnostics, medical devices or pharmaceutical companies.
• This role requires a strategic thinker with a strong technical analytical background in gene therapy and tLNP technologies, manage complex projects, and effectively communicate cross-functionally.

Responsibilities

• Drive overall analytical control strategy and determine critical quality attributes.
• Establish collaborations across the organization to enable analytical activities.
• Set team strategies, manage resources and define risk mitigation.
• Communicate project strategy and risks to key stakeholders.
• Act as principal contact for all stakeholders and balance cross-functional expectations.
• Participate in yearly FTE planning across the analytical organization.
• Coordinate with cross-functional teams to support regulatory submissions.

Skills

Analytical thinking

Cross-functional communication

Gene therapy

TLNP technologies

Education

Bachelor’s Degree in Science

Master’s Degree in Science/PharmD

PhD in Science

Job description

AbbVie is seeking a senior leader for Biologics Analytical-CMC Strategy within PDS&T to drive analytical control strategies for late-stage biologics. You will partner cross-functionally with process development, regulatory, and quality to enable regulatory submissions and robust method development.

The role calls for a strategic thinker with extensive industry experience in gene therapy and tLNP technologies, a track record of scientific innovation, and the ability to steer complex projects