AbbVie The Associate Director / Director leads biologics drug product development including ultra-high concentration formulation and process development. This role manages a portfolio of pipeline programs and supervises a team of scientists.
Responsibilities
Provide strategic and technical oversight for drug product development of ultra-high concentration drug product formulation and process development and technology transfer, including fixed dose combinations for a wide range of biologics modalities.
Oversee drug product development of a portfolio of 5-7 pipeline programs spanning early- and late-stage development, including management of external partnerships as appropriate.
Effective and timely communication of development plans, risks, and mitigation plans to stakeholders and line management.
Initiate and/or sponsor scientific initiatives to drive innovation, continuously enhance capabilities and platforms, and improve business processes.
Accountable for the timely authoring of high-quality technical reports as well as drug product sections in global regulatory filings.
Serve as drug product development subject matter expert in due diligence of external opportunities.
Supervise and mentor a team of 8-10 scientists that may include technical group leaders.
This position can be hired at either the Associate Director or Director level depending on education and years of experience.
Qualification
DirectorAssociate DirectorKey Competencies
Required
Director: BS, MS, or PhD in Pharmaceutics, Pharmaceutical Sciences, Chemistry, Chemical Engineering, or related disciplines with 18+ (Bachelors), 16+ (Masters), or 10+ (PhD) years of relevant industry experience.
Associate Director: BS, MS, or PhD in Pharmaceutics, Pharmaceutical Sciences, Chemistry, Chemical Engineering, or related disciplines with 16+ (Bachelors), 14+ (Masters), or 8+ (PhD) years of relevant industry experience.
Proven ability to solve critical scientific problems.
Extensive experience in biologics (proteins, conjugates, peptides and/or neurotoxins), parenteral synthetic molecules and/or genetic medicine (AAV, LNPs, cell therapy) drug product development.
Experience in sterile manufacturing unit operations (freeze-thaw, compounding, mixing, filtration and filling, lyophilization) development.
Experience leading drug product development as the functional lead within cross-functional teams.
5+ years of progressive people management roles.
Preferred
Experience with development and commercialization of ultra-high concentration liquid formulations for fixed dose combinations and drug product-device integration.
Hands-on experience with authoring regulatory filings for biologics and sterile parenteral products.
Understanding of relevant cGMP and regulatory guidance for biologics and sterile parenteral products.
Experience in managing third-party manufacturers of sterile parenteral products.
Experience with quality risk management and control strategies for biologics and sterile parenteral products.
Key Competencies:
Deep scientific knowledge and significant hands-on experience with ultra-high co-formulation development and characterization.
Effectively communicates to influence without authority, drives technical excellence, and inspires continuous improvement.
