Process Development Senior Scientist (Biotech)

Location: Thousand Oaks, California, United States; work is based at the Thousand Oaks office.

Company

hirify.global is a biotechnology company developing, manufacturing, and delivering medicines for serious illnesses across oncology, inflammation, general medicine, and rare disease.

What you will do

• Supervise and provide technical support for analytical teams supporting late-stage product development.
• Lead Attribute Sciences activities for pivotal clinical process development programs.
• Define analytical target profiles and oversee analytical method development, qualification, remediation, and transfer to Quality Control.
• Manage analytical activities at contract manufacturing and testing sites.
• Author technical reports and analytical CMC sections for regulatory submissions, and respond to health authority questions.
• Drive product characterization, process comparability studies, reference standard qualification, and analytical technology improvements.

Requirements

• Doctorate degree; alternatively, a master's degree with 2 years, bachelor's degree with 4 years, associate degree with 8 years, or high school diploma/GED with 10 years of directly related life science experience.
• Preferred doctorate with 5–7+ years of experience in analytical chemistry, biochemistry, or an equivalent field.
• Strong experience developing analytical methods for biologics, including 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, CMC documentation, GLP, GMP, and analytical method validation and transfer.
• Strong technical writing, problem-solving, communication, cross-functional leadership, and decision-making skills.

Nice to have

• Experience with protein-based and live modality therapies, including fusion proteins, gene therapy, and monoclonal, bi- or tri-specific antibodies.
• Experience working with external contract organizations and multidisciplinary biopharmaceutical teams.

Culture & Benefits

• Collaborative, innovative, science-based work environment.
• Comprehensive medical, dental, vision, life, disability, and flexible spending benefits.
• Retirement and savings plan with company contributions, stock-based long-term incentives, and an annual bonus program.
• Award-winning time-off plans and career development opportunities.
• Flexible work models where applicable to the role.

Hiring process

• Applications are accepted until a sufficient number of candidates are received or a candidate is selected.
• Sponsorship for this role is not guaranteed.