Process Development Senior Scientist - Pre-Pivotal Drug Product Technologies (Biologics)

Location: Thousand Oaks, California, United States

Company

hirify.global is a biotechnology company researching, manufacturing, and delivering medicines across oncology, inflammation, general medicine, and rare disease.

What you will do

• Design and develop liquid and lyophilized formulations for monoclonal antibodies, multispecifics, and other biologic modalities.
• Plan and execute formulation, stability, fill/finish, and process development studies for early-stage programs.
• Evaluate critical quality attributes, protein degradation, stability, in-use compatibility, and process-related stress responses.
• Develop automated high-throughput formulation screening workflows using robotic liquid handling and automated sample preparation.
• Apply design of experiments, machine learning, AI, advanced data science, and automated data analysis to support formulation and process decisions.
• Author technical and regulatory documents and support technology transfers, batch record review, manufacturing campaigns, and troubleshooting with internal and external partners.

Requirements

• Doctorate degree in a relevant field, or a master’s degree with 3 years of scientific experience, or a bachelor’s degree with 5 years of scientific experience.
• Experience in biologics formulation development, stability testing, and fill/finish operations.
• Experience with high-throughput formulation development, laboratory automation, robotic liquid handling, workflow digitization, and electronic data capture.
• Knowledge of analytical and biophysical techniques including UPLC/HPLC, SEC, IEX, RP-HPLC, HIC, CE-SDS, and subvisible particle analysis.
• Experience with clinical-stage development, manufacturability, risk-based decision-making, and regulatory submissions such as CTAs and BLAs.
• Strong scientific communication skills and experience working in cross-functional, matrixed environments.

Nice to have

• PhD in Pharmaceutics, Biotechnology, Biochemistry, or a related field.
• Experience with Hamilton, Tecan, Beckman Coulter, Opentrons, or equivalent automated laboratory systems.
• Experience applying AI/ML, including LLMs and in-silico tools, to streamline R&D and optimize performance.

Culture & Benefits

• Employee benefits include medical, dental, vision, life, disability, and flexible spending plans.
• Retirement and savings plan with company contributions, stock-based incentives, and an annual bonus program.
• Award-winning time-off plans and career development opportunities.
• Flexible work models may be available where applicable to the role.
• Collaborative, inclusive, science-based environment with cross-functional work across research, manufacturing, regulatory, and process development.