Associate Director/Principal Scientist, CMC Analytical Chemistry (Biotech)

Location: Hybrid, based in the San Francisco, CA or Thousand Oaks, CA 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 and oversee analytical testing and release of drug substance and drug product at contract manufacturers and service providers.
• Lead analytical method development, qualification, validation, implementation, and QC review for drug substances, drug products, intermediates, starting materials, excipients, and packaging materials.
• Develop specifications, design stability programs, provide guidance on shelf-life and expiry dating, and manage reference standard sourcing, testing, inventory, and shipments.
• Establish analytical and quality-control workflows, review controlled cGMP documents, and approve analytical reports, validation protocols, specifications, stability protocols, change controls, and laboratory investigation records.
• Manage analytical data review for in-process testing, batch release, and stability studies, including deviation and OOS/OOT investigations with CMC, QA, and regulatory stakeholders.
• Support regulatory submissions by drafting and reviewing analytical sections of INDs, IMPDs, and NDAs, while contributing to CMC infrastructure, project meetings, and cross-functional delivery.

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 an analytical chemistry setting.
• Good understanding of pharmaceutical analytical methods and related issues.
• Experience developing analytical methods for small molecules and oral dosage-form drug products from preclinical through late-stage clinical development.
• Experience managing drug substance and drug product service providers in analytical matters.
• Extensive knowledge of GLP and cGMP requirements, applicable regulatory guidance, and current analytical-development practices.
• Experience writing CMC sections for regulatory submissions, with IND experience required.
• Excellent computer skills, including Microsoft Office, Excel, and Project.
• Ability to manage multiple priorities and projects effectively.
• Ability to work in a hybrid arrangement from the Thousand Oaks or San Francisco, California offices.

Nice to have

• NDA experience.

Culture & Benefits

• Science-based, data-driven, patient-focused, and forward-thinking working environment.
• Opportunity to contribute to the development of non-opioid medicines for pain and pain-related syndromes.
• Cross-functional collaboration with Quality Assurance, CMC Regulatory Affairs, contract manufacturers, and service providers.