Senior Scientist II - Biologics Drug Product Development

About the role

Biologics Drug Product Development (Bio DPD), a part of Development Sciences within AbbVie’s R&D, is a global organization 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).

Responsibilities

• Lead matrix drug product teams for one or more internal and external projects and represent Bio DPD in the cross-functional Product Presentation and Device Strategy Team (PPDST) and the CMC Team.
• Lead the design and execution of biologics drug product formulation development, characterization and robustness studies.
• Serve as subject matter expert in biologics predictive stability modeling, in-use and administration procedures, and QRM.
• Effectively and timely communicate 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.

Qualifications

• Bachelor's, Master's, or PhD in Pharmaceutics, Pharmaceutical Sciences, Chemistry, Chemical Engineering, or related disciplines with 12+ (Bachelors), 10+ (Masters), or 4+ (PhD) years of relevant industry experience.
• Proven ability to solve critical scientific problems.
• Experience leading drug product development as the functional lead within cross-functional teams.
• Strong experience with biologics (proteins, conjugates, peptides and/or neurotoxins) and/or genetic medicine (AAV, LNPs, cell therapy) formulation development, and QRM.
• Strong experience in predictive stability modeling (statistical, phenomenological and mechanistic, and/or AI/ML) for biologics.
• Strong experience in in-use compatibility and stability for biologics products.
• Strong experience in quality risk management.

Preferred Qualifications

• Understanding of relevant cGMP and regulatory guidance.
• Experience with sterile manufacturing unit operations (freeze-thaw, compounding, mixing, filtration and filling) development, characterization, scale-up and technology transfer.
• Experience in managing third party manufacturers of sterile parenteral products.
• Experience with quality risk management and drug product control strategies.