Associate Director/Principal Scientist, CMC Analytical Chemistry

Location: Hybrid from the San Francisco, California or Thousand Oaks, California offices

Company

hirify.global is a public, clinical-stage biotechnology company developing non-opioid medicines for pain and pain-related syndromes.

What you will do

• Manage preclinical-to-clinical analytical development activities for drug substance, drug product, intermediates, starting materials, excipients, and packaging materials.
• Oversee analytical method development, qualification, validation, QC testing, and batch release at contract manufacturers and service providers.
• Develop specifications and manage stability programs to support shelf-life and expiry dating.
• Lead reference standard sourcing, qualification, inventory, testing, retesting, and shipment activities.
• Review and approve analytical reports, controlled cGMP documents, test data, deviations, and OOS/OOT investigations.
• Support CMC regulatory submissions by authoring and reviewing analytical sections of INDs, IMPDs, and NDAs.

Requirements

• Ph.D. with 8+ years of experience, or BS/MS in chemistry or a related discipline with 10–15 years of industry experience in analytical chemistry.
• Strong knowledge of pharmaceutical analytical methods and analytical development for small molecules and oral dosage forms.
• Experience managing analytical activities with drug substance and drug product service providers.
• Extensive knowledge of GLP, cGMP requirements, regulatory guidance, and current analytical development practices.
• Experience writing CMC sections for regulatory submissions; IND experience is required and NDA experience is highly desirable.
• Ability to work in a hybrid arrangement from the San Francisco or Thousand Oaks, California offices.

Culture & Benefits

• Work in a science-based, data-driven, patient-focused, and forward-thinking organization.
• Collaborate with Quality Assurance, CMC Regulatory Affairs, contract manufacturers, and cross-functional project teams.
• Contribute to the development of CMC infrastructure and company culture.