Associate Director​/Director - Biologics Drug Product Development

About Abb Vie

Abb Vie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about Abb Vie, please visit us at  Follow @abbvie on Linked In, Facebook, Instagram, Xand You Tube.

Biologics Drug Product Development (Bio DPD), a part of Development Sciences within Abb Vie’s R&D, is a global organization that is responsible for drug product formulation and process development, and definition of the product presentation for biologics (proteins, conjugates, peptides, neurotoxins etc.) and genetic medicine (AAV, LNPs, Cell Therapy).

Abb Vie is seeking a highly motivated candidate for the position of Director, located in North Chicago, IL. We are seeking an accomplished scientist with a proven track record in biologics drug product development. This position will be an integral part of the product development and CMC teams and will have strong collaborations with several stakeholders, including discovery research, analytical research and development, bioprocess development, combination products development, product development science and technology, pilot plants and third-party manufacturers.

The role could be filled at the associate director or director level depending on the candidate's qualifications and experience.

Key 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.

The position can be hired at either the Associate Director or Director level depending on education and years of experience.

Required Qualifications:

• 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…