Associate Director, Analytical Development & Quality Control

About the Organization

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 long 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.

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, with several clinical data readouts expected as DMD programs advance across the U.K., EU, and U.S. By year-end 2026, Entrada anticipates four clinical-stage programs in its DMD franchise (ENTR-601-44, ENTR-601-45, ENTR-601-50, and ENTR-601-51), complemented by the ongoing clinical progress of the DM1 collaboration with Vertex (VX-670).

Entrada is a team of leaders in therapeutic development and rare diseases, focused on joining a high-energy, dedicated team that likes to get things done and dramatically improve the lives of patients and their families.

About the Role

You are a motivated, resourceful, and enthusiastic quality control lead excited to be a key contributor for the company at a critical stage in its growth trajectory. You will support the CDMO to oversee the AD&QC aspect of the process performance qualification campaign and ensure all activities are completed according to established timelines and quality standards, and applicable regulatory guidelines. You will support the lifecycle management of the analytical methods and region-specific specifications at the commercial stage. You will work with CMC technical SMEs, QA, and Regulatory to ensure regulatory submission readiness, including authoring and reviewing AD&QC-related sections of IND, IMPD, NDA, MAA, and global regulatory submissions, and providing support in addressing information requests. You will also support the CDMO on GMP commercial manufacturing readiness.

You will be expected to interact across different functional groups, including non-clinical development, Quality Assurance, Regulatory, and CRO/CDMOs. Your ability and desire to thrive in a nimble, fast-paced, results-driven environment will set you up for success.

Responsibilities

• Partner with internal cross-functional teams and external CDMOs to provide AD&QC support for late-stage activities, Process Performance Qualification (PPQ) campaigns, and commercial manufacturing.
• Develop and implement comprehensive AD&QC strategies to support successful regulatory submissions and ensure commercial readiness.
• Lead analytical method lifecycle management activities, including method transfer, validation, verification, comparability assessments, and ongoing method performance monitoring.
• Establish, scientifically justify, and maintain analytical specifications and sampling plans throughout the product lifecycle.
• Author, review, and approve AD&QC-related sections of regulatory submissions, including INDs, IMPDs, NDAs, MAAs, and post-approval supplements.
• Provide AD&QC expertise in support of health authority inspections and responses, ensuring all AD&QC documentation remains compliant with current ICH, FDA, EMA, and other applicable global regulatory requirements.
• Serve as the AD&QC Subject Matter Expert during regulatory inspections, partner audits, and quality system assessments, representing AD&QC functions and ensuring inspection readiness.
• Collaborate closely with DS/DP Development & Manufacturing, Quality Assurance, and Regulatory Affairs to support product development, technology transfer, commercialization, and lifecycle management activities.
• Establish and monitor key AD&QC performance metrics and drive continuous improvement initiatives to enhance quality, regulatory compliance, operational efficiency, and inspection preparedness.

Requirements

• A Ph.D. in Organic Chemistry, Analytical Chemistry, or a related discipline with a minimum of 6 years of late-stage and commercial AD&QC experience in a biotech or pharmaceutical industry.
• Strong knowledge of the requirements for the AD&QC aspect of late-stage and commercial oligo programs, especially PMO and PPMO, is highly desired.
• Extensive experience in regulatory filing, including IND, IMPD, NDA, and MAA.
• Strong knowledge and hands-on experience in regulatory requirements and guidelines (ICH/FDA/EMA/USP/Ph. Eur.) with respect to quality control for oligonucleotides drug product late-stage manufacturing; PMO and PPMO experience is a strong plus.
• Extensive knowledge of cGMP regulations and guidelines.
• Experience contributing to product quality risk assessments to identify critical quality attributes and developing associated limits/specifications.
• Excellent communication (written and verbal) and interpersonal skills.
• Strong attention to detail and results-driven in line with project and team objectives.
• Ability to handle multiple high-priority tasks in parallel to meet organizational goals.

Values

• 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.

Schedule and Location

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 minimum monthly or quarterly travel to the Entrada Therapeutics Headquarters located in Boston, MA.

Benefits

• Comprehensive health, dental, and vision coverage
• Life and disability insurance
• 401(k) match
• Paid, gender-inclusive parental leave
• Holistic support for health and well-being
• Education reimbursement
• Discretionary time off
• Commuting benefits aligned to your working model
• Office location in Boston's Seaport District, steps away from some of the best the city has to offer

Pay

The salary for this opportunity ranges from $172,000 - $202,000. The final base compensation offered will depend on several considerations, which may include but are not 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.