Process Development Senior Scientist (Biotechnology)

Location: Thousand Oaks, California, United States; office-based role

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

• Provide strategic analytical leadership as an Attribute Sciences team lead for pivotal clinical process development programs.
• Supervise and support analytical teams working on late-stage product development.
• Define analytical target profiles and oversee analytical method development, qualification, remediation, and transfer to Quality Control.
• Manage analytical activities and deliverables at contract manufacturing and testing sites.
• Author technical reports and analytical CMC sections for regulatory documents and respond to health authority questions.
• Lead product characterization, process comparability studies, reference standard qualification, and innovation across analytical technologies.

Requirements

• Doctorate degree, or a master's degree with 2 years of directly related life science experience, or a bachelor's degree with 4 years of experience, or equivalent experience based on the stated education pathway.
• Strong experience in analytical chemistry, biochemistry, analytical method development, and biologics such as monoclonal and multispecific antibodies.
• Proficiency with HPLC and CE methods, including reversed-phase, size-exclusion, ion-exchange, affinity HPLC, CE-SDS, and cIEF.
• Knowledge of regulatory requirements, product quality attributes, GLP, and GMP, with experience supporting regulatory filings.
• Ability to develop, validate, transfer, and remediate methods for in-process, release, and stability testing.
• Strong technical writing, problem-solving, communication, cross-functional leadership, and decision-making skills.

Nice to have

• Doctorate degree with 5–7+ years of experience in analytical chemistry, biochemistry, or an equivalent field.
• Experience with protein-based and live modality therapies, including fusion proteins, gene therapy, and bi- or tri-specific antibodies.
• Experience working with external contract organizations on non-GMP and GMP production and testing transfers.

Culture & Benefits

• Collaborative, innovative, science-based environment with cross-functional and geographically distributed teams.
• Comprehensive health, dental, vision, life, disability, retirement, and flexible spending benefits.
• Annual bonus program and stock-based long-term incentives.
• Paid time-off programs and career development opportunities.
• Flexible work models where applicable to the work location.