Process Development Sr Scientist (Biotech)

Location: Onsite at the Thousand Oaks, California office, United States

Salary: $126,066.05–$170,559.95 per year

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

• Lead Attribute Sciences activities for pivotal clinical process development programs involving biologic therapeutics.
• Supervise and provide technical support for analytical teams supporting late-stage product development.
• Define analytical target profiles and oversee analytical method development, qualification, remediation, and transfer to Quality Control.
• Direct product characterization and analytical activities supporting process comparability, regulatory filings, and reference standard qualification.
• Manage analytical work at contract manufacturing and testing sites and track deliverables against timelines.
• Author technical reports and analytical CMC sections and respond to product-quality questions from health authorities.

Requirements

• PhD, PharmD, or MD with relevant postdoctoral experience; or a master’s degree with 3 years of scientific experience; or a bachelor’s degree with 5 years of scientific experience.
• Strong experience in analytical chemistry, biochemistry, analytical method development, and characterization of biologics such as monoclonal and multispecific antibodies.
• Proficiency in mass spectrometry, including intact mass and peptide mapping, as well as HPLC and CE methods.
• Experience developing, validating, transferring, and remediating methods for in-process, release, and stability testing.
• Knowledge of GLP, GMP, regulatory requirements, CMC documentation, and regulatory filing authoring.
• Strong technical writing, problem-solving, cross-functional leadership, communication, and decision-making skills.

Nice to have

• Experience with protein-based and live modality therapies, including fusion proteins, gene therapy, and bi/tri-specific antibodies.
• Experience working with multidisciplinary teams in a biopharmaceutical setting.

Culture & Benefits

• Collaborative, innovative, and science-based working environment.
• Health, dental, vision, life, disability, and flexible spending benefits.
• Retirement and savings plan with company contributions.
• Annual bonus program and stock-based long-term incentives.
• Paid time-off plans and career development opportunities.