AbbVie Associate Director/ Director, CMC Sciences in Worcester, Massachusetts

Associate Director/ Director, CMC Sciences

USA, Massachusetts, Worcester

1 additional location

USA, Massachusetts

Research & Development

Requisition #1900182

AbbVie Bioresearch Center is looking for an Associate Director/ Director, CMC Sciences to join their team in Worcester, MA. The Associate Director/ Director, CMC Sciences will be responsible for CMC leadership and project management for biologics projects.

  • Responsibilities include development of comprehensive project plans, budgets, timelines and strategy.

  • Position functions as the interface between multiple departments and divisions, including discovery, process development, manufacturing, analytical, quality assurance/control, formulation development and clinical/toxicology groups in support of biologics CMC activities.

  • Frequent interaction with partner companies will also be a requirement of the position.

  • Responsible for biologics projects at all stages of development from phase I through commercial launch.

  • Position must understand and present technical information regarding drug substance and drug product biologics manufacturing, process development, characterization and comparability to management and to regulatory agencies; this includes the preparation and review of regulatory briefings and submissions to support clinical trials through registration of the product as well as post-approval life-cycle management.

  • Manage multiple projects at various stages of development, and represent assigned projects on the multidisciplinary Asset Development Team.

Position will be hired based on level of experience.

  • BS, MS or Ph.D. in biochemistry, biochemical engineering, cell biology or related field with 16-18+ (BS), 14-16+ (MS) or 8-10+ (PhD) years of biologics manufacturing/development experience is required.

  • Knowledge and experience with FDA and global regulatory requirements for CMC issues is required.

  • Significant technical understanding and experience with biologics manufacturing as well as associated quality and analytical issues is required.

  • Experience in biologics manufacturing process support and/or development, or analytical development is needed.

  • Very strong writing, presentation and communications skills are essential.

  • Experience in program/project management is highly desirable.

  • Familiarity with delivery devices for parenteral products is desirable.

Equal Opportunity Employer Minorities/Women/Veterans/Disabled

Additional Information

  • Travel: Yes, 5 % of the Time

  • Job Type: Experienced

  • Schedule: Full-time