Associate Director, Analytical Development & Quality Control

The role

You will lead late-stage AD&QC activities related to the safety, identity, and purity of oligonucleotides programs. This includes supporting CDMOs, managing analytical method lifecycles, and ensuring regulatory submission readiness for drug substances and products.

What you will do

• Partner with internal cross-functional teams and external CDMOs for late-stage activities and commercial manufacturing.
• Develop and implement AD&QC strategies for regulatory submissions and commercial readiness.
• Lead analytical method lifecycle management including transfer, validation, and verification.
• Establish and maintain analytical specifications and sampling plans.
• Author, review, and approve AD&QC-related sections of regulatory submissions like IND, IMPD, NDA, and MAA.
• Provide AD&QC expertise for health authority inspections and responses.
• Serve as the AD&QC Subject Matter Expert during regulatory inspections and partner audits.
• Collaborate with DS/DP Development, Quality Assurance, and Regulatory Affairs.
• Establish and monitor key AD&QC performance metrics and drive continuous improvement.

Required qualifications

• 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
• 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.)
• 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

Nice to have

• Strong knowledge of the requirements for the AD&QC aspect of late-stage and commercial oligo programs, especially PMO and PPMO
• PMO and PPMO experience is a strong plus

Benefits

• 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

About the company

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. They are advancing a development portfolio of genetic medicines for the potential treatment of neuromuscular and inherited retinal diseases.