Senior Manager, Drug Product Manufacturing (Biotech)

Location: On-site in Waltham, Massachusetts, United States; fully remote work is not possible.

Salary: $150,000–$185,000 USD base pay per year

Company

hirify.global develops 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 clinical and commercial drug product manufacturing for large-molecule parenteral programs, including liquid and lyophilized sterile injectables.
• Serve as the primary technical owner for manufacturing at CDMOs, providing oversight and strategic direction from pre-IND through commercial stages.
• Drive manufacturing execution, including batch record and process documentation review, clinical supply planning, and batch disposition.
• Troubleshoot manufacturing deviations, process failures, and yield issues while leading investigations, CAPAs, and change controls.
• Lead technology transfers, process improvements, validation activities, and manufacturing process characterization.
• Represent drug product manufacturing in cross-functional teams and author technical reports and regulatory filing sections.

Requirements

• Degree in chemistry, chemical engineering, pharmaceutical science, or an equivalent field, with either a BS and 8 years of experience or an MS and 3 years of experience.
• Experience with parenteral drug product clinical manufacturing and direct CDMO oversight across multiple clinical phases.
• Strong knowledge of sterile manufacturing processes, equipment, and fill-finish unit operations.
• Experience with batch record review, deviation management, technology transfer, cGMP, and FDA/EMA regulatory expectations.
• Ability to troubleshoot complex manufacturing challenges and support multiple programs and vendors in a fast-paced environment.
• Strong written, verbal, interpersonal, and cross-functional communication skills.

Culture & Benefits

• Work closely with QA, CMC, regulatory, supply chain, internal laboratory, and external manufacturing partners.
• Support clinical supply for multiple neuromuscular disease programs.
• Maintain an on-site presence at CDMOs during batch manufacturing when required.
• Work in a demanding, multi-program environment with responsibilities spanning development through commercial manufacturing.