Process Development Senior Scientist (Drug Product Technologies)

Location: Thousand Oaks, California, United States

Company

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

What you will do

• Plan and lead formulation, stability, process development, and fill/finish studies for early-stage biologic drug products.
• Develop and characterize liquid and lyophilized formulations for ADCs, oligonucleotides, monoclonal antibodies, multispecifics, and other complex modalities.
• Integrate formulation, analytical, stability, process, manufacturability, and regulatory data to guide product and development strategies.
• Investigate critical quality attributes, degradation pathways, aggregation, particulates, charge and size variants, drug-to-antibody ratio, payload integrity, and oligonucleotide purity.
• Apply high-throughput tools, AI, machine learning, automation, and data science to accelerate screening, predictive modeling, data integration, and decision-making.
• Support technology transfer, technical documentation, regulatory submissions, CMO/CDMO collaboration, manufacturing campaigns, troubleshooting, and mentorship of junior scientists.

Requirements

• Doctorate degree; or a master’s degree with 2 years of scientific experience; or a bachelor’s degree with 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 foundation in analytical and biophysical techniques including UPLC/HPLC, SEC, IEX, RP-HPLC, HIC, CE-SDS, LC-MS, particle analysis, viscosity, osmolality, and stability-indicating methods.
• Experience with clinical-stage development, manufacturability, technology transfer, risk-based decision-making, technical reports, and regulatory submissions.
• Strong cross-functional communication and scientific leadership skills.

Nice to have

• Direct experience with ADCs, siRNAs, oligonucleotides, or other complex biologic modalities.
• Experience with linker-payload stability, drug-to-antibody ratio, payload impurities, oligonucleotide degradation, and modality-specific quality attributes.
• Experience applying AI/ML, LLMs, in silico tools, automation, or data science to R&D workflows.

Culture & Benefits

• Collaborative, innovative, science-based environment with cross-functional and external partner collaboration.
• Comprehensive medical, dental, vision, life, disability, and flexible spending benefits.
• Retirement and savings plan with company contributions, stock-based long-term incentives, and discretionary annual bonus program.
• Paid time off, work-life balance support, and career development opportunities.
• Flexible work models where applicable to the posted 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.