Process Development Senior Scientist (Biologics)

Location: Flex Commuter / Hybrid, US - California - Thousand Oaks, United States

Salary: $126,066.05–$170,559.95 annual base salary

Company

hirify.global is a biotechnology company researching, manufacturing, and delivering medicines for serious illnesses across areas including heart disease, obesity, rare diseases, inflammatory conditions, and cancer.

What you will do

• Participate in commercialization teams for pipeline and commercial biologics, including lifecycle management.
• Design, execute, document, and interpret formulation and process development studies for liquid biologics drug products and co-formulations.
• Build process understanding across unit operations and develop scalable, manufacturable drug product processes.
• Apply statistical analysis, data science, AI, and machine learning to predictive modeling, workflow acceleration, and decision-making.
• Prepare technical protocols, reports, risk assessments, and regulatory sections for IND and marketing submissions.
• Support technology transfers, manufacturing operations, process capability assessments, troubleshooting, root cause analysis, and cross-functional process improvement initiatives.

Requirements

• PhD, PharmD, or MD, with relevant postdoctoral experience where applicable; or a master’s degree plus 3 years of scientific experience; or a bachelor’s degree plus 5 years of scientific experience.
• Experience in biologics drug product formulation and co-formulation across modalities such as enzymes, monoclonal antibodies, and peptides.
• Understanding of protein attributes, stability, degradation pathways, critical quality attributes, and product/process comparability.
• Experience developing or characterizing enzymes, including activity, stability, and performance under formulation or process conditions.
• Experience with fill-finish process engineering, technical transfers to global manufacturing sites, statistical process control, and statistical design and analysis of experiments.
• Foundation in analytical and biophysical techniques relevant to biologics, including UPLC/HPLC, SEC, IEX, RP-HPLC, HIC, CE-SDS, and subvisible particle analysis.
• Programming experience and experience using AI-enabled tools and data visualization tools such as Tableau or Spotfire.
• Communication skills and experience contributing to regulatory submissions such as CTAs and BLAs.
• Project management, critical thinking, problem-solving, independent research, and cross-functional collaboration skills in a fast-paced matrixed environment.

Nice to have

• PhD in Pharmaceutics, Biotechnology, Chemical Engineering, Bioengineering, Biochemistry, or a related field.
• Two to four years of postdoctoral or industry experience.
• Experience integrating formulation, stability, and analytical data to advance enzyme, monoclonal antibody, and peptide candidates.

Culture & Benefits

• Collaborative, innovative, and science-based work environment.
• Health, dental, vision, life, disability, and flexible spending benefits for eligible employees and dependents.
• Retirement and savings plan with company contributions.
• Discretionary annual bonus, stock-based long-term incentives, and award-winning time-off plans.
• 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.
• Sponsorship is not guaranteed.