Process Development Sr Principal Scientist (Biotechnology)

Location: Thousand Oaks, California, United States

Company

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

What you will do

• Lead and mentor analytical scientists supporting process development and provide career development guidance.
• Lead analytical method development for synthetic small molecules, peptides, and/or siRNA manufacturing, release testing, and characterization.
• Define analytical control strategies for late-phase clinical programs and support process performance qualification, regulatory submissions, marketing authorization, and commercial launch.
• Collaborate with Process Development, Manufacturing, Quality, Regulatory, external partners, and contract manufacturing and testing sites.
• Provide technical leadership, resolve complex analytical challenges, and summarize key decisions for cross-functional leadership.
• Author technical reports and analytical CMC sections and respond to health-authority inquiries.

Requirements

• PhD, PharmD, or MD with 2 years of scientific experience; or a master's degree with 5 years; or a bachelor's degree with 7 years of scientific experience.
• Experience in pharmaceutical or biotechnology process and product development, including analytical method development for small molecules, peptides, and/or oligonucleotides.
• Hands-on experience with method development, validation, transfer, in-process testing, release testing, and stability testing.
• Strong knowledge of oligonucleotide characterization and analytical control strategies, including mass spectrometry, plus proficiency with MS, UV, NMR, FTIR, and related techniques.
• Knowledge of USP and ICH/FDA guidance, GLP, GMP, structure elucidation, impurities, and analytical method transfer and validation.
• Excellent technical writing and communication skills, with the ability to work across geographic locations and time zones.

Nice to have

• PhD in Analytical Chemistry, Organic Chemistry, Physical Chemistry, Materials Science, Pharmaceutical Sciences, or a related discipline.
• Experience transferring non-GMP and GMP production and testing to external contract organizations.
• Experience informing and defending Quality Target Product Profiles with CMC and non-clinical teams.

Culture & Benefits

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