Senior Scientist II - Biologics Drug Product Development

Key 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

• Bachelors, Masters, 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.