Process Development Sr Scientist (Analytical Chemistry)

Location: Thousand Oaks, California, United States

Company

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

What you will do

• Define analytical control strategies and implement methodologies 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 purity, chiral purity, and structure elucidation using mass spectrometry and related techniques.
• 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 related protocols and reports.
• Support technical reports and analytical CMC sections for regulatory submissions; mentor a small group of scientists when needed.

Requirements

• PhD, PharmD, or MD with relevant postdoctoral experience; or a master’s degree with 3 years of Scientist experience; or a bachelor’s degree with 5 years of Scientist experience.
• PhD in Analytical Chemistry, Organic Chemistry, Physical Chemistry, Materials Science, Pharmaceutical Sciences, or a related discipline.
• At least 2 years of post-PhD pharmaceutical or biotechnology industry experience in process and product development and analytical method development.
• Experience with conjugate method development and characterization, including mass spectrometry.
• Hands-on experience with method development, validation, and transfer for in-process, release, and stability testing.
• Knowledge of MS, UV, NMR, FTIR, USP and ICH/FDA guidance, GLP, GMP, technical transfer, regulatory writing, and cross-functional collaboration.

Culture & Benefits

• Collaborative, innovative, and science-based work environment.
• Employee benefits including medical, dental, vision, life, disability, and flexible spending plans.
• Retirement and savings plan with company contributions.
• Annual bonus program and stock-based long-term incentives.
• Paid time-off plans and flexible work models where applicable.