AbbVie Associate Director/ Director, CMC Sciences in Worcester, Massachusetts
Associate Director/ Director, CMC Sciences
USA, Massachusetts, Worcester
1 additional location
Research & Development
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
Travel: Yes, 5 % of the Time
Job Type: Experienced