Director, Process Chemistry (Biopharmaceutical API Development)

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

Salary: $177,000–$242,000 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 activities at contract manufacturing organizations.
• Oversee synthesis route and early-stage process identification, technology transfer, scale-up, optimization, characterization, validation, and clinical or commercial manufacturing.
• Collaborate with research teams on lead optimization and early development programs through a discovery process chemistry approach.
• Provide technical operations support, review quality documentation, and manage schedules, raw material consumption, budgets, and process improvement projects.
• Develop and support manufacturing CMC strategy across the product lifecycle.

Requirements

• PhD and at least 5 years of experience managing development and execution of API manufacturing processes.
• At least 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, and statistical process control.
• Experience authoring drug substance CMC sections of regulatory filings and dossiers.
• Strong awareness of regulatory, quality assurance, and cGMP requirements, with strong communication and interpersonal skills.

Nice to have

• PhD in organic chemistry with an organic synthesis focus, or chemical engineering with crystallization or solid-state expertise.
• 10+ years of experience managing API manufacturing development and execution for products marketed in the US, EU, and Japan across the development-to-launch lifecycle.

Culture & Benefits

• Human-centered culture focused on patients, curiosity, collaboration, and meaningful scientific progress.
• Medical, dental, vision, and mental health support, 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) with company match, annual equity awards, ESPP, and company-paid life and disability insurance.
• Learning programs, mentorship, employee resource groups, recognition programs, and volunteer opportunities.