Associate Director, Drug Product Development & Manufacturing (Biopharmaceutical)

Location: Hybrid position based in Boston, MA, with on-site work 2–3 days per week; travel to CDMOs is estimated at 20% or as needed.

Salary: $175,355–$201,235 USD per year

Company

hirify.global is a clinical-stage biopharmaceutical company developing genetic medicines that engage intracellular targets for neuromuscular and inherited retinal diseases.

What you will do

• Lead drug product formulation, characterization, process development, technology transfer, scale-up, and manufacturing for early- to late-stage pipeline programs.
• Oversee formulation, aseptic filling, visual inspection, investigations, and change controls at CDMOs.
• Provide on-site oversight during manufacturing campaigns to support quality, disciplined execution, and timely technical decisions.
• Review master and executed batch records and cGMP documentation to support batch disposition and release.
• Author and review technical protocols, reports, manufacturing documentation, deviations, investigations, and change controls.
• Prepare and review drug product sections of IND, IMPD, NDA, and other regulatory filings while collaborating across development, quality, clinical, and external manufacturing teams.

Requirements

• MS in a scientific-related discipline and 8+ years of biotech or pharmaceutical experience preferred.
• Experience in parenteral drug product formulation development and manufacturing, including direct CDMO oversight.
• Strong knowledge of sterile manufacturing, fill-finish operations, batch records, deviations, change controls, and technology transfer.
• Ability to author and review technical protocols, reports, manufacturing documentation, and regulatory documents.
• Knowledge of cGMP, ICH, FDA, and EMA guidelines for sterile drug product development and manufacturing.
• Strong communication, organization, cross-functional collaboration, and multi-program management skills.

Nice to have

• Direct experience with intravitreal injections.
• Late-stage drug product development and manufacturing experience.

Culture & Benefits

• Mission-driven environment focused on patients, scientific innovation, tenacity, creativity, collaboration, and curiosity.
• Health, dental, and vision coverage; life and disability insurance; and a 401(k) match.
• Paid gender-inclusive parental leave, health and well-being support, education reimbursement, discretionary time off, and commuting benefits.
• Collaborative work across internal functional groups and external CRO/CDMO partners.