Associate Director, Drug Product Development & Manufacturing

Associate Director, Drug Product Development & Manufacturing

Boston, MA

What's happening at Entrada Therapeutics? Entrada is a clinical-stage biopharmaceutical company aiming to transform the lives of patients by establishing a new class of medicines that engage intracellular targets that have long been considered inaccessible. Through proprietary and versatile approaches, Entrada is advancing a robust development portfolio of genetic medicines for the potential treatment of neuromuscular and inherited retinal diseases, among others.

Our lead oligonucleotide programs are in development for the potential treatment of people living with Duchenne muscular dystrophy (DMD) who are exon 44, 45, 50 and 51 skipping amenable. Entrada has partnered with Vertex Pharmaceuticals to develop a clinical-stage program, VX-670, for myotonic dystrophy type 1 (DM1).

2026 represents a catalyst-rich period for Entrada. We expect multiple clinical data readouts as we advance several DMD programs across the U.K., EU, and U.S. By year-end 2026, we anticipate four clinical-stage programs in our DMD franchise (ENTR-601-44, ENTR-601-45, ENTR-601-50, and ENTR-601-51). These programs are complemented by the ongoing clinical progress of our DM1 collaboration with Vertex (VX-670).

We are a tight-knit team of experts and leaders in both therapeutic development and rare diseases and are excited to grow and attract colleagues who are ready to join a high-energy, dedicated team that likes to get things done and dramatically improve the lives of patients and their families.

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.

• 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.

At Entrada, our passion for science, our devotion to patients and our values drives our behavior:

• Humanity - We genuinely care about patients and about one another.
• Tenacity - We are relentless and persistent in the pursuit of developing therapies for patients.
• Creativity - We are creative problem solvers.
• Collaboration - We are more than the sum of our parts.
• Curiosity - We have a growth mindset and push conventional thought and theory.

To thrive on our team, you will need to come with:

• 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. Direct experience with intravitreal injections is a plus.
• Strong knowledge of sterile manufacturing and fill-finish operations with demonstrated experience with batch records, deviations, change controls, and tech transfer. Late-stage experience is a plus.
• 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.

This is a hybrid position based out of the Entrada Therapeutics Headquarters located in…