Principal Research Scientist , 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, X and 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 Principal Research Scientist I, 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.

Key Responsibilities:

• Act as the DP Team Lead and represent the Bio DPD function in the cross-functional Product Presentation and Device Strategy Team (PPDST) and the CMC Team for one or more pipeline programs spanning early- and late-stage development.
• Serve as a technical expert in ultra-high concentration co-formulation and product development.
• Lead the design and execution of biologics drug product formulation and process development, characterization and robustness studies.
• Lead drug product process scale-up and technology transfer activities to internal and external manufacturing sites.
• Effective and timely communication of development plans, risks, and mitigation plans to stakeholders and line management.
• Initiate and/or support scientific initiatives to drive innovation, continuously enhance capabilities and platforms, and improve business processes.
• Supervise a team of 2-3 scientists that may include other DP team leads.

Required Qualifications:

• BS, MS, or PhD in Pharmaceutics, Pharmaceutical Sciences, Chemistry, Chemical Engineering, or related disciplines with 14+ (Bachelors), 12+ (Masters), or 6+ (PhD) years of relevant industry experience.
• Proven ability to solve critical scientific problems.
• Experience with biologics (proteins, conjugates, peptides and/or neurotoxins), parenteral synthetic molecules and/or genetic medicine (AAV, LNPs, cell therapy) drug product formulation development.
• Experience with sterile manufacturing unit operations (freeze-thaw, compounding, mixing, filtration and filling, lyophilization), characterization, scale-down models, simulation, scale-up, technology transfer, and batch record authoring.
• Experience leading drug product development workstream as the functional lead within cross-functional teams

Preferred Qualifications:

• Experience with development and commercialization of ultra-high concentration liquid formulations for fixed dose combination products.
• 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…