Associate Director, Drug Product Development & Manufacturing

Entrada Therapeutics•Boston, MA

2d•Hybrid

About The Position

The Associate Director, Drug Product Development & Manufacturing, is accountable for leading drug product manufacturing activities to support Entrada’s clinical stage assets and novel pipeline programs. This role ensures successful execution of clinical manufacturing operations for parenteral drug products and partners cross-functionally to deliver uninterrupted clinical supply.

Requirements

MS in a scientific related discipline with 8 + years of biotech or pharmaceutical experience preferred.
Experience in parenteral drug product formulation development and manufacturing, with demonstrated ability to provide CDMO oversight.
Strong knowledge of sterile manufacturing and fill-finish operations with demonstrated experience with batch records, deviations, change controls, and tech transfer.
Demonstrated ability to lead authoring and review of technical study protocols and reports, manufacturing documentation, and regulatory documents.
Knowledge of cGMP, ICH, FDA and EMA guidelines regarding sterile drug product development and manufacturing.
Excellent verbal and written communication skills.
Ability to stay highly organized while managing multiple programs in a fast-paced environment and working effectively across functions.
Desire to work in an innovative and collaborative environment.
Ability to travel (estimated 20% or as needed) to CDMOs for supporting manufacturing campaigns.

Nice To Haves

Direct experience with intravitreal injections is a plus.
Late-stage experience is a plus.

Responsibilities

Lead drug product formulation, characterization, process development, technology transfer, scale-up, and manufacturing activities for early to late-stage pipeline programs.
Develop, author, review, and approve technical study protocols, reports, and documentation related to development and manufacturing.
Serve as a subject matter expert and provide direct oversight for drug product manufacturing activities at CDMOs including formulation, aseptic filling, visual inspection, manufacturing investigations, and change controls.
Responsible for driving execution of current production plan at CDMOs with long-term vision.
Provide PIP/on-site oversight at CDMOs during manufacturing campaigns to support disciplined execution, ensure quality, and deliver timely technical input.
Facilitate timely execution, disposition, and release of drug product batches through detailed technical review of master batch records, executed batch records, and other cGMP documentation.
Author and review deviation reports, investigations, and change controls.
Author/review related sections in regulatory filing documents (IND, IMPD, NDA, etc.).
Collaborate cross-functionally across a wide variety of teams, including Discovery, Chemistry, DS Development & Manufacturing, Analytical Development & Quality Control, Quality Assurance, Clinical Operations, and CRO/CDMOs.