Associate Director, Analytical Development & Quality Control

Entrada Therapeutics•Boston, MA

7d•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 multiple programs expected in 2026. Entrada is seeking a motivated, resourceful, and enthusiastic quality control lead to support CDMO oversight of analytical development and quality control (AD&QC) aspects of process performance qualification campaigns. This role will also support the lifecycle management of analytical methods and region-specific specifications at the commercial stage. The position involves collaboration with CMC technical SMEs, QA, and Regulatory to ensure readiness for regulatory submissions, including authoring and reviewing AD&QC related sections of various regulatory filings and addressing information requests. Additionally, the role will support CDMOs in GMP commercial manufacturing readiness. This is a cross-functional role requiring interaction with non-clinical development, quality assurance, regulatory, and CRO/CDMOs, and thrives in a nimble, fast-paced, results-driven environment.

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

PMO and PPMO experience is a strong plus.

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.