Entrada Therapeutics

Associate Director, Drug Substance Development & Manufacturing

Boston, MA · Director

Sponsorship not specified$44k-$601kDetected 8 days ago

Project ManagementExcelSupply ChainGMPFDA RegulatoryCommunicationCollaborationProblem SolvingGxPRegulatory Affairs

About the role

This role will be instrumental in supporting development activities for clinical and commercial batches and ensuring validation parameters for manufacturing batches.

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.
Conduct risk assessments and develop mitigation strategies for manufacturing-related issues.
Implement and manage the Continuous Process Verification (CPV) program to ensure manufacturing process remain in a constant state of control and meet validated parameters.
Author/review related sections in regulatory filing documents (IND, IMPD, NDA, BLA, MAA, etc.).
Meaningful Work, Fair Rewards, and Real Support
At Entrada, we know that meaningful work deserves meaningful reward - and we view compensation as one way we show appreciation for the collaboration, curiosity and commitment that drive our mission forward."

Identify and resolve manufacturing issues and escalate appropriately to internal and/or joint governance if required.
Partner with Entrada team for CDMO due diligence during new CDMO selection to vet capabilities, risks and investments required.
Other tasks as assigned or as required for a given program.
Master's or suitable advanced degree in organic chemistry or other scientific or engineering discipline with 8+ years of related experience in pharmaceutical industry.
Demonstrated proficiency in process development, tech transfer, scale-up, GMP manufacturing DS for clinical, and commercial supplies.

At Entrada Therapeutics, we understand that compensation and total rewards are a major consideration when exploring a new opportunity.

At Entrada Therapeutics, we understand that compensation and total rewards are a major consideration when exploring a new opportunity.
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
"Our approach to compensation is grounded in transparency, equity and performance for the unique contributions each person brings.

Proficient in managing activities and resolving manufacturing challenges at CDMOs during routine cGMP manufacturing and process validations.
Experienced in onboarding/managing/collaborating with CDMOs, raw material suppliers, testing partners, and other production partners.
Hands-on experience in SPPS/SPOS, downstream purification and lyophilization is highly preferred.
Demonstrated ability to develop and maintain production timelines and budgets.
Up-to-date with industry practices and regulations (e.g. GxP, ISO, ICH, etc.) across multiple health authorities (e.g. FDA and EMA).
Ability to interpret and relate Quality standards for implementation and review.
Strong project management, interpersonal, communication, and problem-solving skills preferable.
Ability to communicate clearly and professionally both in writing and verbally.
Ability to travel up to 20% (domestic and international).
This is a US based remote position with preference given to local New England based candidates. This role will require minimum monthly or quarterly travel to the Entrada Therapeutics Headquarters located in Boston, MA.
At Entrada, our passion for science, our devotion to patients and our values drives our behavior:

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.

rientation, 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

This listing is sourced directly from Entrada Therapeutics's careers page and normalized into a canonical job model.