Principal Research Scientist I, Biologics Drug Product Development
About The Position
AbbVie’s Biologics Drug Product Development (Bio DPD), part of Development Sciences within R&D, develops formulations and processes and defines product presentations for biologics and genetic medicines. The Principal Research Scientist I will be based in North Chicago, Illinois, and will contribute to product development and CMC teams, collaborating with discovery research, analytical research and development, bioprocess development, combination products development, product development science and technology, pilot plants, and third-party manufacturers. The role leads drug product development for one or more pipeline programs across early- and late-stage development. The scientist serves as a technical expert in ultra-high concentration co-formulation and product development, leads formulation and process development and related characterization and robustness studies, and oversees scale-up and technology transfer. The position also supervises a team of two to three scientists and communicates development plans, risks, and mitigation plans to stakeholders and line management.
Requirements
- BS, MS, or PhD in Pharmaceutics, Pharmaceutical Sciences, Chemistry, Chemical Engineering, or a related discipline.
- Relevant industry experience of at least 14 years with a bachelor's degree, 12 years with a master's degree, or 6 years with a PhD.
- Proven ability to solve critical scientific problems.
- Experience developing drug product formulations 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 a drug product development workstream as the functional lead within cross-functional teams.
Nice To Haves
- Experience with development and commercialization of ultra-high concentration liquid formulations for fixed-dose combination products.
- 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.
- Deep scientific knowledge and significant hands-on experience with ultra-high co-formulation development and characterization.
- 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, integrate data and information quickly, and take risks to achieve high performance.
- A commitment to raising standards and challenging the status quo.
- Ability to create a learning environment that is open to suggestions and experimentation.
- Ability to embrace others' ideas, nurture innovation, and bring innovation to reality.
Responsibilities
- Act as the Drug Product Team Lead and represent Bio DPD on the cross-functional Product Presentation and Device Strategy Team and CMC Team for one or more pipeline programs spanning early- and late-stage development.
- Serve as a technical expert in ultra-high concentration co-formulation and product development.
- Lead the design and execution of biologics drug product formulation and process development, characterization, and robustness studies.
- Lead drug product process scale-up and technology transfer activities to internal and external manufacturing sites.
- Communicate development plans, risks, and mitigation plans to stakeholders and line management effectively and in a timely manner.
- Initiate or support scientific initiatives to drive innovation, enhance capabilities and platforms, and improve business processes.
- Supervise a team of two to three scientists, potentially including other Drug Product Team Leads.
Benefits
- Paid time off, including vacation, holidays, and sick time.
- 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
Education Level
Ph.D. or professional degree
