Senior Scientist I / II

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 and genetic medicine (proteins, conjugates, peptides etc.).
AbbVie is seeking a highly motivated candidate for the position of Senior Scientist I, Biologics Drug Product Development, located in North Chicago, IL. We are seeking an accomplished scientist with a proven track record in biologics formulation and process development, and characterization. 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, science and technology, pilot plants and third-party manufacturers.
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.
Keep abreast of the latest advances in biologics formulation and process technologies.
Initiate and/or support scientific initiatives to drive innovation, continuously enhance capabilities and improve business processes.
May represent the Bio DPD function in the cross-functional Product Presentation and Device Strategy Team (PPDST) and the CMC team.
Effectively and timely communicates study plans, risks and mitigation plans to stakeholder and line management.
This position can be hired at Sr. Scientist I or II depending on education and years of experience.
Qualifications for Sr. Scientist I:
Bachelor’s Degree or equivalent education and typically 10 years of experience, Master’s Degree or equivalent education and typically 8 years of experience, PhD 0+ years of industry experience.
Proven ability to solve critical scientific problems.
Hands-on experience with biologics formulation development.
Hands-on experience with analytical and biophysical characterization of proteins and solid-state characterization methods.
Solid understanding of biologics degradation mechanisms and stabilization strategies.
Hands-on experience with Design of Experiments (DoE), multivariate statistical analyses and data visualization tools.
Highly Preferred Qualifications:
Understanding of relevant cGMP and regulatory guidance.
Experience with sterile manufacturing unit operations (freeze-thaw, mixing, filtration, filling, and lyophilization) development, characterization, scale-up and technology transfer.
Experience in managing third party manufacturers.
Experience with quality risk management and drug product control strategies.
Qualifications for the Sr. Scientist II:
Senior Scientist II: 12+ (Bachelors), 10+ (Masters), or 4+ (PhD) 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
Preferred Qualifications:
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

Employment type
Full-time

Work arrangement
No