Associate Director, Drug Substance Development & Manufacturing (Biotech)

TL;DR

Associate Director, Drug Substance Development & Manufacturing (Biotech): Leading late-stage drug substance development and GMP manufacturing for a novel pipeline of genetic medicines with an accent on process characterization, tech transfer, and CDMO management. Focus on ensuring manufacturing process control, regulatory compliance, and successful clinical/commercial batch execution.

Location: US-based remote with a requirement for monthly or quarterly travel to Boston, MA; preference for local New England candidates.

Salary: $172,000–$202,000

Company

hirify.global is a clinical-stage biopharmaceutical company developing a new class of medicines to engage intracellular targets for the treatment of rare diseases.

What you will do

• Facilitate timely execution and release of drug substance batches through technical review of cGMP documentation.
• Partner with internal and external teams to execute late-stage development activities like Process Characterization and Performance Qualifications.
• Act as a person-in-plant for critical manufacturing activities at CDMOs.
• Implement and manage the Continuous Process Verification (CPV) program.
• Author and review regulatory filing documents including IND, NDA, and BLA.
• Conduct risk assessments and develop mitigation strategies for manufacturing issues.

Requirements

• Master’s degree or higher in organic chemistry or related scientific/engineering discipline.
• 8+ years of related experience in the pharmaceutical industry.
• Demonstrated proficiency in process development, tech transfer, and GMP manufacturing.
• Experience managing CDMOs, raw material suppliers, and production partners.
• Ability to travel up to 20% (domestic and international).
• Must be based in the US with ability to travel to Boston, MA.

Culture & Benefits

• Comprehensive health, dental, and vision coverage.
• 401(k) retirement plan with company match.
• Paid, gender-inclusive parental leave.
• Discretionary time off and commuting benefits.
• Education reimbursement and holistic well-being support.