Process Development Principal Scientist (Drug Product Technologies)

Location: Thousand Oaks, California, United States

Company

hirify.global is a biotechnology company developing, manufacturing, and delivering medicines across oncology, inflammation, general medicine, rare disease, and obesity-related therapies.

What you will do

• Design and develop liquid and lyophilized drug product formulations for ADCs, oligonucleotides, monoclonal antibodies, multispecifics, and other complex biologics.
• Establish robust, scalable fill/finish processes and build process understanding across unit operations.
• Evaluate critical quality attributes, in-use compatibility, stability, degradation pathways, manufacturability, and modality-specific product risks.
• Apply high-throughput tools, AI/ML, automation, and data science to formulation screening, stability assessment, workflow acceleration, and decision-making.
• Lead cross-functional drug product studies, influence development strategies, and provide scientific guidance to research, analytical, regulatory, quality, manufacturing, and external partner teams.
• Author and review technical reports, regulatory submission sections, risk assessments, control-strategy inputs, and technology transfer packages; support manufacturing campaigns and troubleshooting.

Requirements

• Doctorate degree, or a master’s degree with at least 2 years of scientific experience, or a bachelor’s degree with at least 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.
• Strong understanding of biologics and complex modality development, including aggregation, particulates, degradation pathways, 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, particle analysis, viscosity, osmolality, and stability-indicating methods.
• Experience authoring technical reports and contributing to INDs, CTAs, BLAs, or equivalent regulatory filings.

Nice to have

• Direct experience with ADCs, oligonucleotides, or siRNAs, including linker-payload stability, drug-to-antibody ratio, free payload, oligonucleotide degradation, and modality-specific quality attributes.
• Experience applying AI/ML, LLMs, in silico tools, automation, or data science to R&D workflows.
• Experience with clinical-stage development, technology transfer, risk-based decision-making, and collaboration with CMOs/CDMOs.

Culture & Benefits

• Collaborative, innovative, science-based environment focused on serving patients.
• Health, dental, vision, life, disability, and flexible spending benefits.
• Retirement and savings plan with company contributions, stock-based long-term incentives, and an annual bonus program.
• Paid time off, work-life balance support, and career development opportunities.
• Flexible work models may be available where applicable to the work location type.

Hiring process

• Applications are accepted until a sufficient number of candidates are received or a candidate is selected.
• Visa sponsorship is not guaranteed.