Process Development Senior Scientist (AI)

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, lead, and execute formulation, stability, process development, and fill/finish studies for early-stage biologic drug product programs.
• Develop and characterize liquid and lyophilized formulations for ADCs, oligonucleotides, monoclonal antibodies, multispecifics, and other complex biologic modalities.
• Integrate formulation, analytical, stability, process, manufacturability, and regulatory data to guide product design and development strategies.
• Investigate critical quality attributes, degradation pathways, aggregation, particulates, charge and size variants, viscosity, and modality-specific attributes such as drug-to-antibody ratio and free payload.
• Apply high-throughput tools, automation, AI/ML, and data science for predictive modeling, workflow acceleration, data integration, and decision-making.
• Support technology transfers, technical documentation, regulatory submissions, CMO/CDMO collaboration, 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.
• Knowledge of biologic drug product development, manufacturability, comparability, degradation pathways, 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, BLAs, or equivalent filings.

Nice to have

• Direct experience with ADCs, oligonucleotides such as siRNAs, or other complex biologic modalities.
• 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 manufacturing support.

Culture & Benefits

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

Hiring process

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