Key Responsibilities:
- Lead matrix drug product teams for internal/external projects; represent Bio DPD in cross-functional Product Presentation and Device Strategy Team (PPDST) and CMC Team.
- Lead 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 quality risk management (QRM).
- Communicate development plans, risks, and mitigation plans to stakeholders and line management.
- Initiate and/or support scientific initiatives to drive innovation, enhance capabilities/platforms, and improve business processes.
Qualifications:
- BS/MS/PhD in Pharmaceutics/Pharmaceutical Sciences/Chemistry/Chemical Engineering or related field; 12+ (BS), 10+ (MS), or 4+ (PhD) years relevant industry experience.
- Proven ability to solve critical scientific problems.
- Experience leading drug product development as 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 predictive stability modeling experience (statistical, phenomenological/mechanistic, and/or AI/ML) for biologics.
- Strong experience in in-use compatibility/stability for biologics products.
- Strong experience in quality risk management.
Preferred Qualifications:
- Understanding of relevant cGMP and regulatory guidance.
- Experience in sterile manufacturing unit operations (freeze-thaw, compounding, mixing, filtration, filling) development, characterization, scale-up, and technology transfer.
- Experience managing third-party manufacturers of sterile parenteral products.
- Experience with quality risk management and drug product control strategies.
Benefits (explicitly stated): Paid time off; medical/dental/vision insurance; 401(k) for eligible employees; eligible for long-term incentive programs.