Associate Director, Drug Substance Development & Manufacturing

The Organization

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 genetic medicines that engage intracellular targets that have long been considered inaccessible. Through proprietary, versatile and modular 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 who are exon 44, 45, 50 and 51 skipping amenable. Entrada has partnered to develop a clinical-stage program, VX‑670, for myotonic dystrophy type 1. 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.

You are a motivated, resourceful, and enthusiastic Drug Substance Development & Manufacturing expert excited to support the company at a critical stage in its growth trajectory. You excel at peptide and/or oligonucleotide late‑stage process development, GMP manufacturing and supply chain of drug substances. You thrive when performing these activities with minimal supervision in a collaborative matrix environment. At Entrada, you will not be siloed, but rather expected to interact across different functional groups, including Chemistry, Analytical, Drug Product, Quality, and CDMOs.

Your ability and desire to thrive in a nimble, fast‑paced results‑driven environment will set you up for success.

The Associate Director of Drug Substance Development and Manufacturing will lead and manage late‑stage drug substance development for Entrada’s novel pipeline programs. This role will be instrumental in supporting development activities for clinical and commercial batches and ensuring validation parameters for manufacturing batches.

• Facilitate timely execution, disposition, and release of intermediate/drug substance batches through detailed technical review of master batch records, executed batch records and other cGMP documentation.
• Partner with internal and external Quality Assurance, Quality Control and Technical Operations teams to execute late‑stage development activities such as Process Characterization and Process Performance Qualifications.
• Act as a person‑in‑plant for smooth execution of critical manufacturing activities for clinical and commercial batches.
• Conduct risk assessments and develop mitigation strategies for manufacturing‑related issues.
• Identify and resolve manufacturing issues and escalation appropriately to internal and/or joint governance if required.
• Implement and manage the Continuous Process Verification (CPV) program to ensure manufacturing process remains in a constant state of control and meet validated parameters.
• Author/review change controls to introduce process improvements through the lifecycle of programs from Phase 1 through Phase 3/validation and commercialization.
• Work closely with other internal functions including chemistry, analytical, quality control, quality assurance, DP, and regulatory affairs to ensure programs are effectively supported and high‑quality standard maintained.
• Partner with Entrada team for CDMO due diligence during new CDMO selection to vet capabilities, risks and investments required.
• Author/review related sections in regulatory filing documents (IND, IMPD, NDA, BLA, MAA, etc.).
• Other tasks as assigned or as required for a given program.

• 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.

• Maste…