Director, CMC Process Chemistry

Location: South San Francisco, California, United States; onsite four days per week at headquarters

Salary: $206,000–$254,000 annually

Company

hirify.global is a precision medicine oncology company developing targeted therapies for genetically defined solid tumors, including small-molecule and antibody-drug conjugate programs.

What you will do

• Lead process chemistry activities supporting drug substance development from preclinical and IND-enabling studies through clinical development and commercialization.
• Manage global CDMOs, including the evaluation, selection, oversight, and coordination of dedicated FTE teams and fee-for-service projects.
• Lead development and GMP manufacturing activities for traditional small molecules and ADC payload/linker programs.
• Author and review technical development reports, batch records, campaign reports, change controls, CAPAs, deviations, and investigations.
• Prepare technical CMC sections for IND, IMPD, and NDA submissions while applying current ICH, FDA, and EMA guidance.
• Oversee technology transfers, troubleshoot manufacturing issues, and collaborate with Medicinal Chemistry, DMPK, Analytical Chemistry, Formulation, Toxicology, Quality, Regulatory, and Clinical teams.

Requirements

• Ph.D. in Chemistry with at least 8 years of development experience, or an M.Sc. with at least 12 years of development experience.
• Demonstrated success leading cross-functional groups and delivering drug substance and CMC activities on schedule.
• Experience supporting preclinical, IND-enabling, NDA, and commercialization material supplies; ADC payload/linker manufacturing experience is desired.
• Strong knowledge of quality systems, SOPs, batch record review, batch release and disposition, Good Documentation Practices, cGMP data traceability, deviations, and change management.
• Established knowledge of ICH, FDA, and EMA guidelines and regulatory expectations.
• Ability to travel domestically and internationally to oversee development and manufacturing at CDMOs.

Culture & Benefits

• Collaborative, inclusive, and data-driven environment focused on precision oncology and patient outcomes.
• Medical, dental, and vision coverage, with the company paying 100% of employee premiums and 90% of dependent premiums.
• 401(k), ESPP, wellness programs, merit-based salary increase eligibility, short-term incentive participation, and potential stock option awards.
• Work-from-home flexibility is available alongside required onsite work, and employees working at company facilities must be fully vaccinated subject to applicable accommodations.