Associate Director, Analytical Development & Quality Control

Entrada Therapeutics•Boston, MA

8d•$172,000 - $202,000•Remote

About The Position

Entrada Therapeutics is a clinical-stage biopharmaceutical company focused on developing a new class of medicines for intracellular targets. The company is advancing genetic medicines for neuromuscular and inherited retinal diseases, with lead oligonucleotide programs for Duchenne muscular dystrophy (DMD) and a collaboration with Vertex Pharmaceuticals for myotonic dystrophy type 1 (DM1). Entrada is experiencing significant growth and is seeking motivated, resourceful, and enthusiastic individuals to join their team. This role will support the oversight of Analytical Development & Quality Control (AD&QC) aspects of process performance qualification campaigns and ensure adherence to timelines, quality standards, and regulatory guidelines. The position will also support the lifecycle management of analytical methods and specifications for commercial-stage products, collaborate with various internal and external stakeholders, and contribute to regulatory submission readiness. The ideal candidate will thrive in a fast-paced, results-driven environment and be able to work across different functional groups.

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
Experience contributing to product quality risk assessments to identify critical quality attributes and developing associated limits/specifications.

Nice To Haves

Preference given to local New England based candidates who can be in office 1 day per week.

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.