Principal Scientist I, Biologics Drug Product Development
About The Position
Biologics Drug Product Development (Bio DPD), part of AbbVie’s R&D Development Sciences organization, is responsible for drug product formulation and process development and defining product presentations for biologics and genetic medicines. AbbVie is seeking an accomplished scientist for a position in North Chicago, Illinois, with a proven track record in biologics drug product formulation and process development, scale-up, and technology transfer. The role is an integral part of product development and CMC teams, collaborating with stakeholders across discovery research, analytical research and development, bioprocess development, combination products development, product development science and technology, pilot plants, and third-party manufacturers. The position represents Bio DPD in cross-functional teams and leads biologics drug product formulation and process development activities.
Requirements
- BS, MS, or PhD in Pharmaceutics, Pharmaceutical Sciences, Chemistry, Chemical Engineering, or a related discipline.
- Principal Scientist I: 14 or more years of relevant industry experience with a bachelor's degree, 12 or more years with a master's degree, or 6 or more years with a PhD.
- Proven ability to solve critical scientific problems.
- Experience with drug product process development for biologics (proteins, conjugates, peptides, and/or neurotoxins), parenteral synthetic molecules, and/or genetic medicines (AAV, LNPs, or cell therapy).
- Experience with sterile manufacturing unit operations, including freeze-thaw, compounding, mixing, filtration and filling, and lyophilization.
- Experience with characterization, scale-down models, simulation, scale-up, technology transfer, and batch record authoring.
- Experience leading drug product development as the functional lead within cross-functional teams.
- Deep scientific knowledge and significant hands-on experience with drug product process development and technology transfer.
- Ability to communicate effectively to influence without authority, drive technical excellence, and inspire continuous improvement.
- Ability to build strong relationships with peers and cross-functional partners.
- Ability to connect ideas from disparate fields, quickly integrate data and information, and take risks to achieve high performance.
- Commitment to raising the bar, challenging the status quo, creating a learning environment, embracing others’ ideas, and turning innovation into practice.
Nice To Haves
- Hands-on experience authoring regulatory filings for biologics and sterile parenteral products.
- Understanding of relevant cGMP and regulatory guidance for biologics and sterile parenteral products.
- Experience managing third-party manufacturers of sterile parenteral products.
- Experience with quality risk management and control strategies for biologics and sterile parenteral products.
Responsibilities
- Represent Bio DPD in the cross-functional Product Presentation and Device Strategy Team (PPDST) and the CMC Team.
- Communicate development plans, risks, and mitigation plans to stakeholders and line management effectively and in a timely manner.
- Support scale-up and technology transfer activities at internal and external manufacturing sites.
- Lead the design and execution of biologics drug product formulation and process development, characterization, and robustness studies.
- Initiate or support scientific initiatives that drive innovation, enhance capabilities and platforms, and improve business processes.
Benefits
- Paid time off, including vacation, holidays, and sick leave.
- Medical, dental, and vision insurance for eligible employees.
- 401(k) for eligible employees.
- Eligibility to participate in long-term incentive programs.
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What This Job Offers
Job Type
Full-time
Career Level
Principal
