Senior or Executive Director (Analytical Development and QC)

Location: Remote - US; San Diego HQ. Travel up to 15% domestically and internationally.

Salary: Senior Director $224K–$280K; Executive Director $248K–$310K annually.

Company

hirify.global Therapeutics is a clinical-stage life-science and technology company developing medicines with an AI-driven discovery and development platform.

What you will do

• Lead analytical development and QC strategy for small-molecule drug substance and drug products from early clinical development through commercialization.
• Oversee analytical method development, validation, transfer, lifecycle management, troubleshooting, stability, specifications, impurity control, and product characterization.
• Direct QC release and stability testing, including OOS/OOT investigations, deviations, root-cause analysis, CAPAs, and analytical issue resolution.
• Lead dissolution and product-performance testing for conventional oral solid dosage forms.
• Manage external CDMOs and testing laboratories, including partner selection, technical oversight, governance, and performance management.
• Provide analytical CMC leadership for regulatory submissions, health authority interactions, manufacturing readiness, and cross-functional program execution.

Requirements

• Ph.D. in Analytical Chemistry or a related field with 12+ years of pharmaceutical or biotech experience; alternatively, an M.Sc. with 14+ years or a B.Sc. with 17+ years.
• Extensive hands-on experience with analytical methods for small-molecule drug substance and drug products across early- and late-stage development.
• Strong knowledge of analytical control strategies, specifications, impurity and degradation-product control, reference standards, stability-indicating methods, dissolution, and product characterization.
• Experience supporting IND/IMPD filings and preferably NDA/MAA submissions, with in-depth knowledge of cGMP laboratory operations, global regulatory expectations, and ICH guidance.
• Proven leadership experience managing teams, multiple programs, external CDMOs, resources, and budgets.
• Excellent written and verbal communication skills for working with internal stakeholders, external partners, and health authorities.

Culture & Benefits

• Inclusive environment focused on collaboration, diversity, and innovation in AI-based drug discovery.
• Company-paid healthcare, flexible spending accounts, voluntary life insurance, and 401(k) matching.
• Uncapped vacation.
• San Diego facility with an onsite gym and dining.