Associate Director, Formulation and Drug Product Development (Biotech)

Location: Waltham, Massachusetts, United States. This is an onsite role with physical presence expected 4-5 days per week; remote work is not available.

Salary: $159,000-$195,000 USD per year.

Company

hirify.global develops bioconjugate therapeutics targeting muscle and the central nervous system to address genetically driven neuromuscular diseases, including Duchenne muscular dystrophy and myotonic dystrophy type 1.

What you will do

• Lead formulation development, container closure selection, sterile fill-finish, and clinical drug product manufacturing activities.
• Serve as the primary contact for CDMOs and coordinate external formulation development from purchase order through delivery.
• Partner with Research to define and execute early-stage formulation development programs.
• Build internal laboratory capabilities for formulation development.
• Lead drug product process development, technology transfer, scale-up, and cGMP manufacturing for Phase 1-3 clinical programs.
• Contribute to drug product sections of IND, IMPD, and Health Canada clinical filings while coordinating with Technical Development, Manufacturing, Quality, and Regulatory Affairs.

Requirements

• PhD or equivalent experience in a scientific discipline and 8+ years of relevant experience.
• Clinical drug product formulation experience covering liquid fill-finish, lyophilization, subcutaneous formulations, and other injectables.
• Expertise in sterile fill-finish early clinical manufacturing and analytical techniques supporting manufacturing activities.
• Understanding of external manufacturing operations from development through clinical manufacturing and strong knowledge of cGMP requirements.
• Experience managing complex schedules, priorities, multiple programs, and vendors in a dynamic biotech environment.
• Ability to influence and build consensus across Technical Operations, Quality, Regulatory Affairs, Manufacturing, and Research.

Culture & Benefits

• Collaborative, cross-functional environment focused on teamwork, transparent communication, and commitment to quality.
• Opportunity to support multiple clinical and preclinical programs developing therapies for neuromuscular diseases.
• Fast-paced environment requiring resilience, urgency, and ethical professional judgment.
• Equal opportunity employment environment.