Senior Scientist II - Biologics Drug Product Development
About The Position
Biologics Drug Product Development (Bio DPD), a part of Development Sciences within AbbVie’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). AbbVie is seeking a highly motivated candidate for the position of Senior Scientist II, located in North Chicago, IL. We are seeking an accomplished scientist with a proven track record in biologics drug product formulation development, predictive stability, in-use, and quality risk management (QRM). 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.
Requirements
- 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.
Nice To Haves
- 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.
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.
Benefits
- paid time off (vacation, holidays, sick)
- medical/dental/vision insurance
- 401(k)
- long-term incentive programs
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What This Job Offers
Job Type
Full-time
Career Level
Senior
Education Level
Ph.D. or professional degree
