Principal Research Scientist I, Analytical Lead (R&D)

Location: South San Francisco, California, United States; full-time on-site role with daily in-person collaboration

Salary: $124,500–$236,500 per year

Company

hirify.global develops medicines and solutions for serious health conditions across immunology, oncology, neuroscience, and other therapeutic areas.

What you will do

• Own analytical development strategies for assigned biologic programs, including methods, specifications, CQAs, stability plans, characterization, and comparability assessments.
• Translate analytical strategies into work packages and oversee timely delivery across internal laboratory teams.
• Coordinate method development, validation, transfer, and clinical supply testing with Quality Control and external contract laboratories.
• Interpret release, stability, and characterization data trends and collaborate with process and drug product development teams.
• Author and review regulatory submissions, technical reports, validation documents, and responses to health authority queries.
• Communicate risks, resource needs, budgets, and program updates to project, functional, and analytical leadership.

Requirements

• Degree in Chemistry, Biochemistry, Analytical Chemistry, or a related field.
• Relevant industry experience: PhD with 6+ years, MS with 12+ years, or BS with 14+ years.
• Comprehensive knowledge of analytical methods for protein therapeutics, including HPLC, capillary electrophoresis, mass spectrometry, potency assays, ELISA, cell-based assays, CD, DSC, and light scattering.
• Experience with analytical development project management and authoring or reviewing INDs/IMPDs and health authority responses.
• Knowledge of GxP laboratory investigations, change records, exception reports, and global regulatory requirements including ICH, FDA, and EMA.
• Ability to work on-site in South San Francisco with daily in-person collaboration, strong communication, collaboration, critical thinking, and problem-solving skills.

Nice to have

• Experience with biologic compounds such as multi-specifics, monoclonal antibodies, antibody-drug conjugates, or fusion proteins.
• Statistical knowledge, design of experiments, stability trending, and experience with statistical software such as JMP.

Culture & Benefits

• Work in a cross-functional and global biologics analytical sciences organization.
• Collaborate from a state-of-the-art facility with end-to-end CMC development capabilities.
• Benefits include paid time off, holidays, sick leave, medical, dental, and vision insurance.
• Eligible employees receive access to a 401(k) and long-term incentive programs.