Associate Director, Drug Product Manufacturing (Biotech)

Location: Waltham, MA; onsite

Salary: $160,000–$196,000 USD per year

Company

hirify.global develops therapeutics targeting muscle and the central nervous system to address genetically driven neuromuscular diseases.

What you will do

• Lead clinical and commercial manufacturing activities for large-molecule sterile injectable drug products, including liquid and lyophilized formulations.
• Own technical oversight of drug product manufacturing at CDMOs across campaigns from pre-IND through commercial production.
• Maintain an onsite presence at CDMO manufacturing campaigns and provide real-time technical guidance.
• Lead investigations into manufacturing deviations, process failures, and yield issues, including CAPAs and change controls.
• Drive technology transfers, process improvements, validation activities, and evaluation of scalable manufacturing technologies.
• Partner with Quality Assurance, supply chain, process development, and regulatory teams to ensure compliant execution and uninterrupted clinical supply.

Requirements

• Bachelor’s degree in Chemistry, Chemical Engineering, Pharmaceutical Sciences, or a related discipline; an advanced degree is preferred.
• 8+ years of relevant drug product manufacturing experience with a bachelor’s degree, or 3+ years with a master’s degree.
• Experience in parenteral drug product manufacturing and CDMO oversight.
• Strong knowledge of sterile manufacturing, fill-finish operations, batch records, deviations, and technology transfer.
• Deep understanding of cGMP and FDA and EMA regulatory expectations.
• Strong troubleshooting, communication, collaboration, and program-management skills.

Culture & Benefits

• Work supports the development and commercialization of therapies for Duchenne muscular dystrophy, myotonic dystrophy type 1, and other neuromuscular diseases.
• Cross-functional collaboration spans manufacturing, quality, supply chain, process development, and regulatory functions.
• Work is performed onsite in Waltham, Massachusetts, with regular onsite presence at CDMO manufacturing campaigns.