Director/Senior Director, Drug Product

About the role

Damora Therapeutics is seeking a Director or Senior Director to lead drug product development for monoclonal antibody biologics. Reporting to the SVP of Technical Operations, you will shape formulation, process development, technical transfer, and manufacturing strategies for vials and prefilled syringes.

Key responsibilities

• Define and execute drug product development strategy to achieve high‑yield, high‑purity, scalable processes for clinical and commercial supply.
• Develop robust formulations and manufacturing processes for clinical trial material while maintaining product quality.
• Oversee technical activities at CDMOs, including technology transfer, CTM production, process troubleshooting, QbD studies, risk assessments, registration batch production, and validation.
• Provide technical leadership to resolve formulation challenges, design of experiments, and interpret results with CDMO partners.
• Lead design of experiments and incorporate Quality by Design principles into process characterization and optimization.

Required profile

• Proven experience managing monoclonal antibody drug product programs through development, licensure, and commercialization.
• Strong background in formulation and process development for biologics.
• Demonstrated ability to lead cross‑functional teams and work with external CDMOs.
• Excellent problem‑solving skills and a data‑driven approach to process optimization.

Required skills

• Monoclonal antibody drug product development
• Formulation development
• Process development
• Technical transfer
• Quality by Design (QbD)
• Process validation
• Design of experiments (DoE)