Note: The job is a remote job and is open to candidates in USA. Entrada Therapeutics is seeking an Associate Director to lead late-stage analytical development and quality control activities for oligonucleotide programs. The role supports process qualification and commercial manufacturing, analytical method lifecycle management, and regulatory submission and inspection readiness.
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
Skills
- 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
- 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
- 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
- Strong knowledge of the requirements for the AD&QC aspect of late-stage and commercial oligo programs, especially PMO and PPMO, is highly desired
- PMO and PPMO experience is a strong plus
Benefits
- Comprehensive health, dental and vision coverage
- Life and disability insurance
- 401(k) match
- Paid, gender-inclusive parental leave
- Holistic support for your health and well-being
- Education reimbursement
- Discretionary time off
- Commuting benefits aligned to your working model
- US-based remote position, with preference given to local New England based candidates who can be in office 1 day per week
Company Overview
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