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

Location: Thousand Oaks, California, United States

Annual salary: USD 126,066.05–170,559.95

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

• Design and execute formulation and fill/finish process studies for early-stage biologic drug product programs.
• Develop and characterize liquid and lyophilized formulations, including laboratory-scale sterile filling.
• Build process understanding across unit operations to support scalable drug product development.
• Evaluate critical quality attributes, in-use compatibility, stability, protein–excipient interactions, and process-related stress responses.
• Apply AI, machine learning, laboratory automation, and advanced data science to predictive modeling and R&D workflow acceleration.
• Prepare technical documents, regulatory submission sections, control-strategy inputs, risk assessments, technology-transfer packages, and support manufacturing campaigns with internal and external partners.

Requirements

• PhD, PharmD, or MD; 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.
• Understanding of biologics drug product development, protein degradation, critical quality attributes, and product/process comparability.
• Experience integrating formulation, stability, and analytical data to advance biologics into clinical manufacturing.
• Knowledge of analytical and biophysical techniques such as UPLC/HPLC, SEC, IEX, RP-HPLC, HIC, CE-SDS, and subvisible particle analysis.
• Strong technical communication skills and experience contributing to regulatory submissions such as CTAs and BLAs.

Nice to have

• PhD in Pharmaceutics, Biotechnology, Biochemistry, or a related field with 2–4 years of postdoctoral or industry experience.
• Experience with laboratory automation, workflow digitization, AI/ML, LLMs, in silico tools, or electronic data capture.
• Familiarity with clinical-stage development, manufacturability, and risk-based decision-making.

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.
• Discretionary annual bonus and stock-based long-term incentives.
• Paid time-off programs and career development opportunities.