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← Entrada Therapeutics

Associate Director, Analytical Development & Quality Control

Entrada Therapeutics
Location
Boston, MA
Posted
19 days ago
Department
Technical Operations
Salary
$172,000 - $202,000
What they actually want (must-haves)
  • 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 AD&QC requirements for late-stage and commercial oligo programs
  • Extensive experience in regulatory filing, including IND, IMPD, NDA, and MAA
  • Strong knowledge of regulatory requirements and guidelines (ICH/FDA/EMA/USP/Ph. Eur.)
  • Extensive knowledge of cGMP regulations and guidelines
Nice to have
  • Experience with PMO and PPMO programs
  • Experience contributing to product quality risk assessments
What the job really is

As the Associate Director of Analytical Development & Quality Control at Entrada Therapeutics, you will lead late-stage AD&QC activities for oligonucleotide programs, ensuring compliance with regulatory standards and readiness for NDA submissions. Your role involves collaborating with cross-functional teams and external partners, managing analytical methods, and authoring regulatory documents. You will also establish quality metrics and drive continuous improvement initiatives to enhance operational efficiency and inspection preparedness.

Benefits
  • Comprehensive 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
Things to weigh
  • Remote position with preference for local New England candidates who can be in the office once a week
  • Monthly or quarterly travel required to Boston headquarters
  • Salary range provided, but final compensation may vary based on candidate factors
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