Associate Director, Process Chemistry (API Development)

Location: Fully remote; can be performed effectively from anywhere. Occasional domestic and international travel of approximately 10% is expected.

Salary: $155,000–$201,500 annual.

Company

hirify.global is a global biopharmaceutical company focused on transforming the lives of patients with serious and rare diseases.

What you will do

• Manage API, intermediate, and RSM manufacturing at contract manufacturing organizations.
• Oversee synthesis route selection, early-stage process identification, technology transfer, scale-up, optimization, validation, and clinical or commercial manufacturing.
• Collaborate with research teams on lead optimization and early development programs using a discovery process chemistry approach.
• Provide technical expertise, review quality documentation, and manage schedules, raw material consumption, budgets, and process improvement projects.
• Develop and support manufacturing CMC strategies and continued process improvements.

Requirements

• PhD with 2+ years of experience, or Master’s with 6+ years of experience, managing development and execution of API manufacturing processes.
• 5+ years of experience leading pharmaceutical manufacturing technology improvements in a regulated environment.
• Experience managing CMO operations and working with new chemical entities, total synthesis, and physical organic chemistry.
• Working knowledge of quality systems, validation principles, engineering design, statistical process control, regulatory requirements, quality assurance, and cGMP.
• Experience authoring CMC drug substance sections of regulatory filings and dossiers.
• Strong communication and interpersonal skills, with the ability to work in a fast-paced, multidisciplinary environment.

Nice to have

• PhD in synthetic organic chemistry or chemical engineering with crystallization expertise.
• 10+ years of experience managing API manufacturing processes for products marketed in the US, EU, and Japan.

Culture & Benefits

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