Associate Director, Drug Product Dev & Manufacturing

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

Benefits offered by this job

Health, dental and vision coverage

Life and disability insurance

401(k) match

Parental leave

Education reimbursement

Discretionary time off

Commuting benefits

Job summary

Entrada Therapeutics is seeking an Associate Director of Drug Product Development & Manufacturing to lead formulation, characterization, process development, tech transfer, scale-up, and manufacturing for clinical-stage assets. The role requires extensive CDMO oversight and collaboration across functions to ensure uninterrupted clinical supply.

The ideal candidate has a strong background in parenteral DP development, sterile operations, and regulatory documentation, with the ability to drive

Qualifications

• MS in a scientific discipline with 8+ years of biotech or pharmaceutical experience.
• Experience in parenteral drug product formulation development and manufacturing.
• Direct experience with CDMOs and intravitreal injections is a plus.
• Knowledge of cGMP, ICH, FDA and EMA guidelines for sterile drug product development and manufacturing.
• Excellent verbal and written communication.
• Strong organizational skills in a fast-paced environment.

Responsibilities

• Lead drug product formulation, characterization, process development, tech transfer, scale-up, and manufacturing for early to late-stage pipeline programs.
• Develop, author, review, and approve technical study protocols, reports, and documentation related to development and manufacturing.
• Oversee drug product manufacturing activities at CDMOs including aseptic filling, visual inspection, investigations, and change controls.
• Provide on-site oversight at CDMOs during manufacturing campaigns to support disciplined execution, quality, and timely input.
• Facilitate timely execution, disposition, and release of drug product batches through master batch records and cGMP documentation.
• Author/review deviation reports, investigations, and change controls; contribute to regulatory filings (IND/IMPD/NDA).
• Collaborate across Discovery, Chemistry, DS Development & Manufacturing, Analytical Development & Quality Control, QA, Clinical Operations, and CRO/CDMOs.

Skills

Parenteral formulation

CDMO oversight

Aseptic filling

Sterile manufacturing

Tech transfer

Regulatory documentation

Education

MS in a scientific discipline

Job description

Entrada Therapeutics is seeking an Associate Director of Drug Product Development & Manufacturing to lead formulation, characterization, process development, tech transfer, scale-up, and manufacturing for clinical-stage assets. The role requires extensive CDMO oversight and collaboration across functions to ensure uninterrupted clinical supply.

The ideal candidate has a strong background in parenteral DP development, sterile operations, and regulatory documentation, with the ability to drive