Associate Director of Analytical Strategy

5 days ago


North Chicago, Illinois, United States BioSpace, Inc. Full time
Job Summary

We are seeking a highly skilled and experienced Associate Director to join our team in AbbVie's Analytical R&D functions. The successful candidate will be responsible for creating and implementing short and mid-term GMP compliance strategies, managing global interfaces, and developing lean development processes.

Key Responsibilities
  • Develop and implement GMP compliance strategies for Analytical R&D functions, ensuring alignment with global regulatory requirements.
  • Manage local and global interfaces across Small Molecule and Biologics Analytical R&D functions, CMC Regulatory Affairs, Quality Assurance, and other departments.
  • Develop and align phase-appropriate lean development processes, workflows, and GMP approaches for ARD cross-functionally.
  • Author, review, and approve Standard Operating Procedures (SOPs) specific to ARD, advising on compliance harmonization activities.
  • Influence mid- and long-term strategic focus areas of the Global Analytical Strategy and Operations (GASOps) team.
Requirements
  • Bachelor's degree in pharmaceutical sciences, chemistry, food sciences, or related field, with a minimum of 14 years of experience.
  • Advanced degree preferred.
  • Demonstrated extensive knowledge and experience in analytical and/or formulation development, with solid cross-discipline exposure and knowledge of international pharmaceutical regulations and cGMPs.
What We Offer

AbbVie offers a comprehensive package of benefits, including paid time off, medical/dental/vision insurance, and 401(k) to eligible employees. This role is eligible to participate in our short-term and long-term incentive programs.

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives, serving our community, and embracing diversity and inclusion.



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