Executive Director, API Development, Small Molecule

Location: Fully remote and performable from anywhere; occasional travel for team meetings and events is expected, approximately 25%.

Salary: $247,000–$337,000 annual

Company

hirify.global is a global biopharmaceutical company developing treatments for patients with serious and rare diseases.

What you will do

• Set the long-term vision, strategy, and operating model for small-molecule API Development within Technical Operations.
• Lead API process development, technology transfer, process validation, manufacturing readiness, and lifecycle management across development programs.
• Direct process, instrument, and equipment design and scale-up from laboratory through pilot plant and commercial manufacturing.
• Advise Technical Operations and executive leadership on portfolio decisions, resource allocation, risk mitigation, and investment priorities.
• Collaborate with Discovery, Clinical Development, Quality, Regulatory Affairs, Operations, Commercial teams, CROs, CMOs, vendors, and regulatory bodies.
• Build organizational capabilities through coaching, succession planning, leadership development, performance metrics, and continuous improvement.

Requirements

• PhD with 10 years of CMC experience, MS with 12 years, or BS with 15 years of experience in the pharmaceutical industry.
• Extensive expertise in route design, small-molecule API process development, technology transfer, process validation, manufacturing sciences, regulatory strategy, and commercialization readiness.
• Strong experimental skills and the ability to independently identify and solve complex development problems.
• Thorough knowledge of cGxP, CMC, ICH, and USP/EP/JP compendial requirements.
• Experience authoring, reviewing, and approving CMC sections of IND, NDA/MAA, and other regulatory submissions.
• Demonstrated success managing multiple programs, resources, staff, CROs, and CMOs from discovery through commercialization, with exceptional communication and influencing skills.

Nice to have

• Experience with compounds used for inhalation and combination products.

Culture & Benefits

• Fully remote work with support for occasional purposeful in-person collaboration.
• Medical, dental, vision, and mental health coverage, plus annual wellbeing reimbursement and an Employee Assistance Program.
• Paid time off, fertility and family-forming benefits, caregiver support, and flexible work schedules.
• 401(k) matching, annual equity awards, an Employee Stock Purchase Plan, and company-paid life and disability insurance.
• Learning and leadership development programs, mentorship, employee resource groups, and service opportunities.