Process Development Principal Scientist – Drug Product Technologies (Biologics)

Location: Thousand Oaks, California, United States

Annual salary: USD 141,836.95–191,897.05

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

• Lead early-stage drug product development studies covering formulation, process development, technology transfer, and regulatory authoring.
• Develop and characterize liquid and lyophilized formulations for ADCs, oligonucleotides, monoclonal antibodies, multispecifics, and other complex biologics.
• Build process understanding across unit operations and establish scalable fill/finish processes for clinical manufacturing.
• Evaluate critical quality attributes, in-use compatibility, stability, degradation pathways, and modality-specific product risks.
• Apply high-throughput, AI/ML, automation, and data science approaches to formulation screening, predictive modeling, data integration, and decision-making.
• Provide scientific leadership, mentorship, technical guidance, regulatory documentation, and support for internal and external manufacturing transfers.

Requirements

• Doctorate degree, or a master’s degree and 2 years of scientific experience, or a bachelor’s degree and 4 years of scientific experience.
• PhD in Pharmaceutics, Biotechnology, Biochemistry, Chemical Engineering, Pharmaceutical Sciences, or a related field with 3+ years of relevant industry experience preferred.
• Experience in biologics drug product formulation, stability assessment, process development, and/or fill/finish operations.
• Understanding of formulation stability, degradation pathways, aggregation, particulates, manufacturability, comparability, and phase-appropriate control strategies.
• Experience with analytical and biophysical techniques such as UPLC/HPLC, SEC, IEX, RP-HPLC, HIC, CE-SDS, LC-MS, subvisible particle analysis, viscosity, and osmolality.
• Experience authoring technical reports and contributing to regulatory submissions such as INDs, CTAs, or BLAs.

Nice to have

• Direct experience with ADCs, including linker-payload stability, drug-to-antibody ratio, free payload, and ADC-specific quality attributes.
• Experience with oligonucleotide or siRNA formulation, stability, degradation pathways, excipient compatibility, and analytical characterization.
• Experience applying AI/ML, LLMs, in silico tools, automation, or data science to R&D workflows.

Culture & Benefits

• Collaborative, innovative, and science-based work environment.
• Health, dental, and vision coverage, life and disability insurance, and flexible spending accounts.
• Retirement and savings plan with company contributions and stock-based long-term incentives.
• Annual bonus program, award-winning time-off plans, and career development opportunities.
• Flexible work models where applicable to the posted work location.