Principal Research Scientist II, Biologics Drug Product Development

Role Summary

AbbVie Biologics Drug Product Development is seeking a Principal Research Scientist II, located in North Chicago, IL. The role requires a proven track record in biologics drug product process development, modeling, scale-up and tech transfer, and will be an integral part of the product development and CMC teams with collaboration across discovery research, analytical R&D, bioprocess development, and external manufacturers.

Responsibilities

• Lead the early-stage biologics drug product process development group in Lake County, IL
• Accountable for drug product process development, scale-down modeling, process simulation, manufacture of technical batches, and process scale-up and tech transfer for early-stage biologics and sterile parenteral programs
• Initiate and/or support scientific initiatives to drive innovation, continuously enhance capabilities and platforms, and improve business processes
• Serve as a drug product team leader for one or more projects and represent Bio DPD in the cross-functional Product Presentation and Device Strategy Team (PPDST) and the CMC Team
• Effectively and timely communicate development plans, risks, and mitigation plans to stakeholders and line management
• Support due diligence for business development opportunities
• Manage a team of 4-5 scientists and engineers (BSc to PhD level) including other drug product team leaders
• Responsible for performance management, development plans, and recommendations for promotions and transfers for direct reports

Qualifications

• Required: Bachelors, Masters, or PhD in Pharmaceutics, Pharmaceutical Sciences, Chemistry, Chemical Engineering, or related disciplines with 16+ (Bachelors), 14+ (Masters), or 8+ (PhD) years of relevant industry experience
• Required: Proven ability to solve critical scientific problems
• Required: Strong experience with biologics (proteins, conjugates, peptides and/or neurotoxins), parenteral synthetic molecules and/or genetic medicine (AAV, LNPs, cell therapy) drug product process development
• Required: Extensive experience with sterile manufacturing unit operations (freeze-thaw, compounding, mixing, filtration and filling) characterization, scale-down models, simulation, scale-up, technology transfer, and batch record authoring
• Required: Experience as CMC cross-functional matrix team leader
• Required: Hands-on experience with authoring regulatory filings for biologics and sterile parenteral products
• Required: People management experience

Skills

• Deep scientific knowledge and hands-on experience with drug product process development and tech transfer
• Strong communication, collaboration, and leadership abilities to influence without authority
• Ability to build relationships with cross-functional partners to enable high performance
• Ability to integrate data from disparate sources and drive innovation while taking calculated risks
• Commitment to continuous improvement and fostering a learning environment

Education

• Bachelors, Masters, or PhD in Pharmaceutics, Pharmaceutical Sciences, Chemistry, Chemical Engineering, or related disciplines