Senior Scientist II / Principal Scientist I, Biologics Drug Product Development

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.
Key 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.
This position can be hired at the Sr. Scientist II or Principal Scientist I level depending on years of experience and education
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
Qualifications for the Principal Scientist I:
BS, MS, or PhD in Pharmaceutics, Pharmaceutical Sciences, Chemistry, Chemical Engineering, or related disciplines with
Principal Scientist I: 14+ (Bachelors), 12+ (Masters), or 6+ (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.
Experience leading drug product development as the functional lead within cross-functional teams
Preferred Qualifications:
Hand-on experience with authoring regulatory filings for biologics and sterile parenteral products
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
Key Competencies:
Deep scientific knowledge and significant hands-on experience with drug product process development and tech transfer
Effectively communicates to influence without authority, drives technical excellence, and inspires continuous improvement.
Builds strong relationships with peers and cross-functional partners to enable higher performance.
Connects ideas from disparate fields, integrates data and information quickly, and takes risks to achieve the highest performance.
Raises the bar and is never satisfied with the status quo.
Creates a learning environment, open to suggestions and experimentation for improvement.
Embraces the ideas of others, nurtures innovation and manages innovation to reality.

Employment type
Full-time

Work arrangement
No