Process Development Sr Scientist (Analytical Chemistry)

Location: Thousand Oaks, California, United States

Salary: $126,066.05–$170,559.95 annually

Company

hirify.global is a biotechnology company developing and manufacturing medicines for serious illnesses across oncology, inflammation, general medicine, and rare disease.

What you will do

• Define analytical control strategies for late-phase clinical programs.
• Develop, optimize, authorize, and validate analytical methods for small molecules, synthetic peptides, siRNA, and synthetic components of antibody–drug conjugates.
• Provide analytical data for drug substance and drug product development, including purity, chiral purity, and mass spectrometry-based structure elucidation.
• Collaborate with drug substance and drug product process development teams on project objectives.
• Lead method transfers to contract manufacturing organizations or contract testing laboratories and review associated protocols and reports.
• Support technical reports, regulatory CMC documentation, and mentoring of a small group of scientists.

Requirements

• PhD, PharmD, or MD; or a master's degree with 3 years of scientist experience; or a bachelor's degree with 5 years of scientist experience.
• Experience in pharmaceutical or biotech process and product development and analytical method development.
• Hands-on experience with method development, validation, and transfer for in-process, release, and stability testing.
• Proficiency in analytical and structure elucidation techniques including MS, UV, NMR, and FTIR.
• Understanding of organic chemistry, GLP, GMP, USP, and ICH/FDA guidance for analytical methods, impurities, transfer, and validation.
• Strong technical writing, communication, and cross-functional leadership skills.

Nice to have

• PhD in analytical chemistry, organic chemistry, physical chemistry, material sciences, pharmaceutical sciences, or a related discipline.
• Experience with conjugate method development, characterization, and analytical control strategy.
• Experience transferring non-GMP and GMP production or testing to external contract organizations.

Culture & Benefits

• Collaborative, innovative, and science-based work environment.
• Health, dental, vision, life, disability, and flexible spending benefits.
• Retirement and savings plan with company contributions.
• Annual bonus program, stock-based long-term incentives, and paid time off.
• Career development opportunities and flexible work models where applicable.