Associate Director, Drug Product Development & Manufacturing

Job description

## 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 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 Perfect Addition to Our Team You are a motivated, resourceful, and enthusiastic Drug Product Development & Manufacturing individual who is excited to support the company at a critical stage in its growth trajectory. You excel at injectable drug product formulation, development, and GMP manufacturing. If you can lead these activities with minimal supervision, yet thrive in a collaborative setting, this role is for you. At Entrada, you will not be siloed, but rather, expected to interact across different internal functional groups and external vendors. ## The Opportunity 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. ## 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. ## The Necessities 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 US based remote position, with preference given to local New England based candidates who can be in office 1 day per week. This role will require a minimum monthly or quarterly travel to the Entrada Therapeutics Headquarters located in Boston, MA*. ## What We Offer: Meaningful Work, Fair Rewards, and Real Support At Entrada Therapeutics, we understand that compensation and total rewards are a major consideration when exploring a new opportunity. We believe in transparency and equity and are committed to sharing salary ranges for every position, along with insight into our compensation philosophy, in accordance with certain state requirements in the United States and fostering a fair and open environment at the onset. But we also know it is more than just pay. When you join Entrada, you’ll be part of a mission-driven team with access to comprehensive health, dental and vision coverage; life and disability insurance; with a 401(k) match. We pride ourselves on offering competitive benefits that empower our employees and reflect the value of their contributions – offering paid, gender-inclusive parental leave, holistic support for your health and well-being, education reimbursement, discretionary time off and commuting benefits aligned to your working model. If you find yourself working from our office in Boston’s Seaport District, this puts you steps away from some of the best the city has to offer. At Entrada, our approach to compensation is grounded in transparency, equity, and performance, recognizing the unique contributions each person brings. We believe meaningful work deserves meaningful reward, and view compensation as one way to show appreciation for the collaboration, curiosity, and commitment that drive our mission forward. The salary for this opportunity ranges from $175,000 - $201,000. The final base compensation offered will depend on several considerations which include but may not be limited to a candidate’s skills, competencies, experience and other job-related factors permitted by law. The final salary offered may fall outside of this range. #LI-JF1 #LI-Remote Pay transparency $175,355—$201,235 USD ## Equal Opportunity Employer Entrada Therapeutics is an equal opportunity employer. Qualified candidates will receive consideration for employment without regard to race, color, religion, national origin, gender, sexual orientation, gender identity or expression, age, mental or physical disability, and genetic information, marital status, citizenship status, military status, protected veteran status or any other category protected by law. ## Third Party Staffing Agencies Entrada does not accept unsolicited resumes from any source other than directly from candidates. For the protection of all parties involved in the recruiting process, resumes will only be accepted from recruiters/agencies if a signed agreement is in place at the inception of the recruiting effort and authorized for a specified position. Unsolicited resumes sent to Entrada from recruiters/agencies do not constitute any type of relationship between the recruiter/agency and Entrada and do not obligate Entrada to pay fees if we hire from those resumes. ## Privacy Statement Entrada Therapeutics, Inc. (the “**Entrada**,” “**we,**” “**us,**” or “**our**”) respects your privacy and we want you to be familiar with how we collect, use, share, or otherwise process, your Personal Information. Please reference our privacy statement [**here**](https://www.entradatx.com/privacy-notice) to understand how and when your data is being used.