Senior Scientist, Analytical Development and Quality Control - Drug Product (Biopharma)

Location: Onsite in Brisbane, California, United States

Salary: $161,100–$185,600 per year

Company

hirify.global is a clinical-stage biopharmaceutical company developing targeted protein degradation medicines and small-molecule therapies for cancer and inflammatory or immune disorders.

What you will do

• Lead analytical method development, validation, lifecycle management, and control strategies for drug product formulations, including amorphous solid dispersions and lipid-based systems.
• Design and oversee development, registration-batch, and commercial stability programs, including protocols, trend analysis, retest periods, and shelf-life assessments.
• Provide technical oversight of analytical development, validation, and QC testing performed by CDMOs and contract testing laboratories.
• Support PPQ, commercialization, commercial QC, late-phase technology transfer, and validation activities.
• Author and review analytical development reports, specifications, validation and stability documents, certificates of analysis, and regulatory submission sections.
• Contribute to investigations, root-cause analyses, CAPAs, data integrity, inspection readiness, and cross-functional development activities.

Requirements

• BS/MS with 14+ years or PhD with 8+ years of industrial CMC experience; an advanced degree in chemistry, pharmaceutics, or a related discipline is preferred.
• Strong experience in drug product analytical development, validation, chromatography, dissolution methods, stability studies, and phase-appropriate control strategies.
• Experience with amorphous solid dispersions and/or lipid-based formulations, CDMO oversight, and contract testing laboratories.
• Experience supporting IND, IMPD, NDA, and global regulatory filings, with fluency in ICH guidelines, cGMP requirements, and pharmacopeial chapters.
• Strong technical writing, communication, prioritization, and cross-functional collaboration skills.
• Ability to work onsite in Brisbane, California.

Culture & Benefits

• Highly collaborative, team-oriented working environment.
• Solutions- and results-oriented approach with a hands-on and resourceful culture.
• Opportunity to work with multidisciplinary teams across Chemical Development, Pharmaceutical Development, Regulatory, Quality, Preclinical, Supply Chain, Medicinal Chemistry, and DMPK.
• Travel of up to 5% may be required.