Sr. Manager, Drug Product Development & Manufacturing

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 6 + 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.

Additional information

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 $157,678 - $185,077 USD