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 process development, modeling, scale-up and tech transfer. 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
- PhD in Pharmaceutics, Pharmaceutical Sciences, Chemistry, Chemical Engineering, or related disciplines with 4+ 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 process 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.
- Hand-on experience with authoring regulatory filings for biologics and sterile parenteral products
- Experience leading drug product development as the functional lead within cross-functional teams
Nice To Haves
- Biologics drug product formulation development
- 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 strategies for biologics and sterile parenteral products
Responsibilities
- Lead the design and execution of biologics drug product formulation and process development, characterization and robustness studies.
- Support scale-up and technology transfer activities to internal and external manufacturing sites.
- Initiate and/or support scientific initiatives to drive innovation, continuously enhance capabilities and platforms, and improve business processes.
- Effectively and timely communicate development plans, risks, and mitigation plans to stakeholders and line management.
- Represent Bio DPD in the cross-functional Product Presentation and Device Strategy Team (PPDST) and the CMC Team.
Benefits
- paid time off (vacation, holidays, sick)
- medical/dental/vision insurance
- 401(k)
- short-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
