Senior Scientist II - Biologics Drug Product Development
$109,500–$208,500 year
On-site · North Chicago, Illinois, United States
Job Summary
Senior Scientist II in Biologics Drug Product Development leads matrix drug product teams and oversees the design and execution of biologics drug product formulation development, characterization, and robustness studies. The role serves as a subject matter expert in biologics predictive stability, in-use procedures, and quality risk management (QRM), and requires effective communication of development plans, risks, and mitigations to stakeholders. The position emphasizes collaboration across discovery research, analytical development, bioprocess development, and outside manufacturers, with a track record of driving innovation, platform enhancements, and process improvements. Candidates should have advanced degrees (Pharmaceutics/Pharmaceutical Sciences/Chemistry/Chemical Engineering or related) with substantial industry experience, and proven leadership in cross-functional teams, biologics or genetic medicine formulation development, and QRM. The description notes familiarity with cGMP/regulatory guidance, sterile parenteral operations, and third-party manufacturing, and highlights competencies in predictive stability modeling, administration procedures, risk management, and influencing cross-functional partners.
Required Qualifications
- Bachelor's, Master's, or PhD in Pharmaceutics, Pharmaceutical Sciences, Chemistry, Chemical Engineering, or related disciplines with 12+ (Bachelor's), 10+ (Master's), or 4+ (PhD) years of relevant industry experience
- Proven ability to solve critical scientific problems
- Experience leading drug product development as the functional lead within cross-functional teams
- Strong experience with biologics (proteins, conjugates, peptides and/or neurotoxins) and/or genetic medicine (AAV, LNPs, cell therapy) formulation development, and QRM
- Strong experience in predictive stability modeling (statistical, phenomenological and mechanistic, and/or AI/ML) for biologics
- Strong experience in in-use compatibility and stability for biologics products
- Strong experience in quality risk management
- Understanding of relevant cGMP and regulatory guidance
- Experience with sterile manufacturing unit operations (freeze-thaw, compounding, mixing, filtration and filling) development, characterization, scale-up and technology transfer
- Experience in managing third party manufacturers of sterile parenteral products
- Experience with quality risk management and drug product control strategies
- Key Competencies: deep scientific knowledge, effective communication, cross-functional collaboration, continuous improvement, data-driven decision-making
- Applicable to location-specific pay disclosures per state/local law
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