Entrada Therapeutics

Entrada Therapeutics

Associate Director, Analytical Development & Quality Control

Boston, MA · Director

Sponsorship not specified$44k-$601kDetected 51 days ago
ComplianceProduct ManagementIntellectual PropertyClinical TrialsGMPFDA RegulatoryCommunicationCollaborationRegulatory Affairs

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odds of building a lasting career here

59Sponsors, lottery-bound
Cap-exempt (no lottery)0
Sponsors this role80
Entry-level history0
PERM / green-card track0
Lottery odds (Level IV)94
Fits your clock70

Sponsors, but it's cap-subject — you still face the weighted lottery (~61% per draw at Level IV). Good if you win; have a cap-exempt backup on your list.

Lottery odds assume a STEM candidate.

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About the role

  • In this position you will lead late-stage AD&QC activities both internally and externally related to safety, identity, and purity of oligonucleotides programs.
  • This work will support late-stage to commercial CMC activities for drug substances and drug products used in late-phase clinical studies and ensure NDA regulatory submission readiness.
  • Finally, we hope you enjoy communicating your processes and findings across different formats including authoring and reviewing regulatory filings (IND, IMPD, NDA, MAA etc.), patent applications, publications (including review for technical correctness and regulatory compliance) and in internal and external meetings because your work will be critical to the success of the entire company and our ability to treat devastating diseases.

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.
  • 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.
  • Meaningful Work, Fair Rewards, and Real Support

Compensation

  • The salary for this opportunity ranges from $172,000 - $202,000.

Benefits

  • At Entrada Therapeutics, we understand that compensation and total rewards are a major consideration when exploring a new opportunity.
  • When you join Entrada, you'll be part of a mission-driven team with access to comprehensive health, dental and vision coverage
  • life and disability insurance

Company info

  • 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
  • At Entrada, our passion for science, our devotion to patients and our values drives our behavior:
  • Tenacity - We are relentless and persistent in the pursuit of developing therapies for patients.
  • Creativity - We are creative problem solvers.

Equal opportunity

  • Entrada Therapeutics is an equal opportunity employer.
  • Qualified candidates will receive consideration for employment without regard to race, color, religion, national origin, gender, sexual orientation, gender identity or expression, age, mental or physical disability, and genetic information, marital status, citizenship status, military status, protected veteran status or any other category protected by law.
  • Third Party Staffing Agencies
  • Entrada does not accept unsolicited resumes from any source other than directly from candidates.

Visa & Work Authorization

  • rientation, gender identity or expression, age, mental or physical disability, and genetic information, marital status, citizenship status, military status, protected veteran status or any other category protected by law
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This listing is sourced directly from Entrada Therapeutics's careers page and normalized into a canonical job model.