(Associate) Director, Drug Product Operations (Biopharma)

Location: South San Francisco, CA; hybrid schedule with three days per week onsite for local candidates. Remote candidates may be considered if willing to travel to the office as needed.

Salary: $193,000–$246,000 annually for successful US-based applicants, plus eligibility for an annual performance bonus and equity incentive plan.

Company

hirify.global is a drug discovery and development company using machine learning, large-scale data, and human biology to develop therapeutics for neuroscience and metabolic disease.

What you will do

• Define and execute drug product strategy for first-in-human and Phase 2 programs, including formulation interfaces, fill/finish, and primary container selection.
• Lead drug product process development and technology transfer from development through clinical manufacturing.
• Identify and resolve drug product bottlenecks that could delay clinical timelines.
• Select, contract, and provide technical oversight for CDMO partners supporting Phase 1/2 manufacturing.
• Author drug product CMC sections for INDs and Phase 2 filings and address early-phase health authority questions.
• Manage technical budgets and timelines while establishing processes, vendor relationships, documentation practices, and a growing team.

Requirements

• 10+ years of biopharmaceutical development experience with direct ownership of drug substance and drug product process development.
• Experience managing CDMOs for early-phase biologics programs and taking programs from IND-enabling activities through first-in-human dosing and into Phase 2.
• Working knowledge of chromatography, UFDF/formulation, aseptic vial filling, pre-filled syringes, and cartridges.
• Direct experience authoring CMC sections for INDs and resolving early-phase health authority questions.
• Experience leading clinical-scale manufacturing vendors from site selection through technology transfer.
• B.S., M.S., or Ph.D. in Chemical Engineering, Biological Systems Engineering, or a related discipline.

Nice to have

• Familiarity with combination products and delivery devices such as pre-filled syringes and autoinjectors.

Culture & Benefits

• 401(k) plan with employer matching.
• Medical, dental, vision, mental health, and well-being support.
• Open vacation policy and paid parental leave.
• Quarterly budget for books and online courses, plus a home office setup stipend.
• Monthly cell phone and internet stipend.
• Onsite baristas, daily lunch for onsite and hybrid employees, and commuter bus service across the Bay Area.