Associate Director, Analytical Development & Quality Control
New
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Entrada TherapeuticsBiopharmaceutical
This is a US based remote positionFull-TimeManager
Salary172,000 - 202,000 USD per year
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Job Details
- Experience
- 6 years
Requirements
- Ph. D in Organic Chemistry, Analytical Chemistry or a related discipline.
- 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.
- 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.
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.
- 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.
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