Process Development Associate Scientist (Biologics)

Location: US - California - Thousand Oaks

Salary: USD 90,442.55–122,363.45 annually

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 process studies for early-stage biologic drug products.
• Develop and characterize liquid and lyophilized formulations, including lab-scale sterile filling.
• Evaluate critical quality attributes such as aggregation, fragmentation, charge and size variants, subvisible particles, and surface interactions.
• Design automated, high-throughput formulation screening workflows and implement robotic liquid handling and automated sample preparation.
• Apply design of experiments, high-throughput experimentation, AI, machine learning, and automated data analysis to support formulation and process decisions.
• Author technical protocols, reports, technology transfer documents, product impact assessments, and regulatory sections supporting IND submissions.

Requirements

• Master’s degree, or a qualifying combination of a bachelor’s or associate’s degree and scientific experience, or a high school diploma/GED with six years of scientific experience.
• Experience in formulation development and fill/finish operations for biologics is strongly preferred.
• Knowledge of protein physical and chemical stability and the impact of process-related stress on product quality.
• Hands-on experience with automated liquid handling systems, robotic laboratory workflows, workflow digitization, and electronic data capture.
• Familiarity with design of experiments, laboratory robotics, workflow orchestration, and biologics analytical techniques including HPLC/UPLC, SEC, IEX, CE-SDS, and 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, and peptide mapping by mass spectrometry.
• Experience with Hamilton, Tecan, Beckman Coulter, Opentrons, or equivalent automation platforms.

Culture & Benefits

• Health, dental, vision, life, disability, and flexible spending benefits for eligible employees and dependents.
• Retirement and savings plan with company contributions and stock-based long-term incentives.
• Discretionary annual bonus program.
• Award-winning time-off plans and career development opportunities.
• Flexible work models where applicable to the work location type.
• Inclusive, collaborative, science-based work environment.