Associate Director, Formulation & Drug Product Innovation

BioSpace; Waltham (MA); On-site; USD 159,000 - 195,000; Full time

Job summary

Dyne Therapeutics seeks an Associate Director of Formulation and Drug Product Development in Waltham, MA, to drive formulation development for bioconjugate drug products and ensure manufacturability and stability for clinical trials.

This onsite role partners with Research, Quality, Manufacturing and Regulatory to define strategy, oversee tech transfer to CDMOs, and maintain supply for Phase 1-3 programs with lyophilized and high-concentration formulations.

Qualifications

• PhD or equivalent in a scientific discipline with 8+ years related experience.
• Experience in clinical drug product formulation development including liquid fill finish, lyophilization, subcutaneous formulations, and other injectables.
• Understanding of CGMP manufacturing requirements and external manufacturing operations from development to clinical manufacturing.

Responsibilities

• Act as subject matter expert for drug product development, including formulation development and sterile fill finish.
• Liaise with CDMO(s) for external formulation development activities and coordinate with Research for early-stage development.
• Lead tech transfer, scale-up and cGMP manufacturing of clinical-grade drug product (Phase 1-3).
• Collaborate with Regulatory, Quality, Manufacturing to ensure continuity of drug supply for early clinical evaluation.

Education

PhD or equivalent in a scientific discipline

Job description

Dyne Therapeutics seeks an Associate Director of Formulation and Drug Product Development in Waltham, MA, to drive formulation development for bioconjugate drug products and ensure manufacturability and stability for clinical trials.

This onsite role partners with Research, Quality, Manufacturing and Regulatory to define strategy, oversee tech transfer to CDMOs, and maintain supply for Phase 1-3 programs with lyophilized and high-concentration formulations.