Drug Product Development & Manufacturing Lead

Entrada-Therapeutics; Boston (MA); On-site; USD 175,000 - 201,000; Full time

Job summary

Entrada Therapeutics seeks an Associate Director, Drug Product Development & Manufacturing to lead parenteral drug product formulation, development, and GMP manufacturing for clinical assets. The role spans cross-functional oversight of CDMOs, tech transfer, and batch release, with travel to sites as needed.

Based in the US with remote capabilities and occasional on-site presence in Boston, MA, you will partner across Discovery, Chemistry, Analytical Development, QA, and Clinical Operations to

Qualifications

• MS in a scientific discipline with 8+ years of biotech/pharma experience preferred.
• Experience in parenteral drug product formulation development and manufacturing with CDMO oversight.
• Knowledge of sterile manufacturing, fill-finish operations, and cGMP/ICH/FDA/EMA guidelines.

Responsibilities

• Lead drug product formulation, characterization, process development, tech transfer, scale-up, and manufacturing for early to late-stage programs.
• Develop, review, and approve technical studies, reports, and manufacturing documentation.
• Provide oversight of CDMOs and on-site manufacturing activities; ensure disciplined execution of production plans.
• Collaborate across multiple internal functions and CRO/CDMOs to deliver uninterrupted clinical supply.

Skills

CDMO oversight

Parenteral formulation

Regulatory documentation

Cross-functional collaboration

Travel readiness

Education

MS in scientific discipline

Tools

Sterile manufacturing

Quality systems

Job description

Entrada Therapeutics seeks an Associate Director, Drug Product Development & Manufacturing to lead parenteral drug product formulation, development, and GMP manufacturing for clinical assets. The role spans cross-functional oversight of CDMOs, tech transfer, and batch release, with travel to sites as needed.

Based in the US with remote capabilities and occasional on-site presence in Boston, MA, you will partner across Discovery, Chemistry, Analytical Development, QA, and Clinical Operations to