Director, Biologics Development

Location: Waltham, MA, United States; regular onsite presence required four to five days per week

Salary: $190,000–$230,000 USD annually

Company

hirify.global develops therapeutics targeting muscle and the central nervous system to deliver functional improvement for people living with genetically driven neuromuscular diseases.

What you will do

• Lead biologics process development, optimization, and execution for scalable clinical and commercial manufacturing.
• Define CMC strategies for preclinical and clinical programs within a cross-functional matrixed organization.
• Serve as the primary technical lead for external CDMOs, including selection, qualification, governance, and technology transfer.
• Partner with Research and Platform Innovation teams to assess developability and manufacturability and transition new biologics assets into Technical Development.
• Resolve complex manufacturing and analytical issues using timely, data-driven approaches.
• Author and review technical documents, publications, presentations, and Module 3 sections for global regulatory filings.

Requirements

• Bachelor’s degree in Biology, Biochemistry, Pharmaceutical Sciences, or a related discipline; an advanced degree is preferred.
• 10+ years of biopharmaceutical industry experience with progressive responsibility in biologics development.
• Experience advancing biologics from early development through clinical cGMP manufacturing.
• Deep expertise in protein expression, purification, biologics process development, analytical development, impurity control, viral safety, and physicochemical characterization.
• Experience defining CMC strategies, managing CDMOs, leading technology transfers, and contributing to Module 3 regulatory filings.
• Strong leadership, project management, communication, problem-solving, and cross-functional influence skills.

Culture & Benefits

• Work in a matrixed, cross-functional environment spanning Research, Platform Innovation, Technical Development, Quality, and Regulatory functions.
• Contribute to programs addressing Duchenne muscular dystrophy, myotonic dystrophy type 1, facioscapulohumeral muscular dystrophy, Pompe disease, and other DMD mutations.
• Drive implementation of emerging technologies and continuous improvement initiatives to improve product quality, manufacturing efficiency, and cost of goods.
• Support development of proprietary bioconjugation-platform products through clinical and commercial readiness.