Process Development Senior Scientist - Drug Product Technologies (Biotechnology)

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

• Plan and execute formulation and fill/finish process studies for early-stage biologic drug products.
• Develop and characterize liquid and lyophilized formulations, with emphasis on antibody-drug conjugates (ADCs).
• Build process understanding across unit operations to support scalable drug product development and clinical manufacturing.
• Evaluate critical quality attributes, in-use compatibility, stability, degradation pathways, and process-related stress responses.
• Apply high-throughput tools, AI/ML, and data science to accelerate formulation screening, predictive modeling, and R&D decisions.
• Author regulatory and technical documentation and support technology transfer, CMO/CDMO collaboration, manufacturing campaigns, and troubleshooting.

Requirements

• PhD, PharmD, or MD with relevant experience; alternatively, a master's degree with 3 years of scientific experience or a bachelor's degree with 5 years of scientific experience.
• Experience in biologics formulation development, stability testing, and fill/finish operations; direct ADC drug product formulation experience is strongly preferred.
• Understanding of ADC linker-payload stability, drug-to-antibody ratio, free payload degradation, quality attributes, and product/process comparability.
• Experience with analytical and biophysical techniques such as UPLC/HPLC, SEC, IEX, RP-HPLC, HIC, CE-SDS, and subvisible particle analysis.
• Experience with clinical-stage development, manufacturability, risk-based decision-making, and applying AI/ML to R&D.
• Strong scientific communication skills and experience contributing to CTA or BLA regulatory submissions.

Culture & Benefits

• Collaborative, innovative, science-based work in a fast-paced, matrixed environment.
• Employee benefits including medical, dental, vision, life, disability, and flexible spending plans.
• Retirement and savings plan with company contributions, stock-based long-term incentives, and an annual bonus program.
• Award-winning time-off plans and flexible work models where applicable.
• Opportunities for career development and cross-functional collaboration with research, regulatory, manufacturing, and external partners.