Process Development Associate Scientist - Pre-Pivotal Drug Product Technologies

Location: Thousand Oaks, California, United States

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

• Plan and execute formulation, stability, end-use compatibility, and fill/finish studies for early-stage biologics programs.
• Develop and characterize liquid and lyophilized formulations, including laboratory-scale sterile filling.
• Evaluate biologics-relevant critical quality attributes, including aggregation, fragmentation, charge and size variants, particles, and surface interactions.
• Design automated high-throughput formulation screening workflows and implement robotic liquid handling and sample preparation systems.
• Apply design of experiments, high-throughput experimentation, AI, machine learning, and automated data analysis to formulation and process development.
• Prepare technical documentation, product impact assessments, and regulatory sections supporting IND submissions, while presenting results cross-functionally.

Requirements

• Master’s degree, or a bachelor’s degree with 2 years of scientific experience, or an associate degree with 4 years of scientific experience, or a high school diploma/GED with 6 years of scientific experience.
• Experience with biologics formulation development and fill/finish operations; direct biologics drug product formulation experience is strongly preferred.
• Knowledge of protein physical and chemical stability and the effect of process-related stress on product quality.
• Experience with high-throughput formulation development, automated liquid handling systems, robotic laboratory workflows, and electronic data capture.
• Foundation in analytical techniques such as UPLC/HPLC, SEC, IEX, RP-HPLC, HIC, CE-SDS, and subvisible particle analysis.
• Strong written and oral communication skills and the ability to work in a matrixed, cross-functional environment.

Nice to have

• Master’s degree in pharmaceutics, biotechnology, biochemistry, physical biochemistry, biophysics, chemical engineering, or a related field.
• Three or more years of industrial experience in pharmaceutical, biotechnology, or a related field.
• Experience with light scattering, DSF, AUC, FFF, mass spectrometry, and peptide mapping.
• Familiarity with workflow orchestration, laboratory robotics, and workflow digitization.

Culture & Benefits

• Collaborative, innovative, science-based work environment.
• Comprehensive 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.
• Flexible work models where applicable, depending on the work location type.