Principal Scientist I, Biologics Analytical R&D (External Programs)

Location: North Chicago, Illinois, United States

Salary: USD 124,500–236,500 per year

Company

hirify.global develops medicines and solutions across immunology, oncology, neuroscience, and aesthetics, including innovative therapeutic biologics.

What you will do

• Lead analytical strategies for stability studies, product control strategies, comparability studies, and extended characterization of biologics.
• Coordinate with third-party laboratories to deliver analytical development activities within CMC timelines.
• Interpret data trends from analytical release and stability assays.
• Author and review regulatory documents, laboratory data, technical memoranda, and reports.
• Advise colleagues and senior management, mentor peers, and contribute to project management and analytical strategy development.
• Lead or participate in continuous improvement initiatives while maintaining scientific, safety, conduct, and GxP standards.

Requirements

• MS with 12+ years of experience, or PhD with 6+ years, in Chemistry, Biochemistry, or Biology.
• At least 6 years of experience in a pharmaceutical laboratory setting.
• Experience leading analytical development activities for biologics such as monoclonal antibodies, antibody-drug conjugates, or fusion proteins.
• Strong knowledge of protein HPLC, including SEC, IEX, and HIC, capillary electrophoresis, and other protein separation techniques.
• Scientific writing and verbal communication skills, with the ability to collaborate with internal and external partners.
• Full-time onsite work in North Chicago, Illinois, United States.

Nice to have

• Experience with LIMS, CDS, or ELN laboratory systems.
• Statistical knowledge including capability analysis, gauge R&R, and design of experiments methodologies.

Culture & Benefits

• Work with global, cross-functional teams in biologics analytical research and development.
• Collaborate with external laboratories, consortia, and internal CMC partners.
• Eligible employees receive paid vacation, holidays, sick leave, medical, dental, and vision insurance.
• Eligible employees receive 401(k) benefits and may participate in long-term incentive programs.