Remote Associate Director, Analytical Development & QC

Entrada Therapeutics; Boston (MA); On-site; USD 172,000 - 202,000; Full time

Job summary

Entrada Therapeutics in Boston, MA, is seeking an Associate Director, Analytical Development & Quality Control to lead late-stage AD&QC activities, manage regulatory submissions, and ensure GMP compliance for oligonucleotide programs.

You will collaborate with CMC SMEs, QA, Regulatory, and CDMOs, support IND/IMPD/NDA/MAA filings, and help readiness for inspections, with a US-based remote role requiring periodic travel to the Boston headquarters.

Qualifications

• PhD in Organic Chemistry or Analytical Chemistry with ≥6 years in late-stage and commercial AD&QC.
• Extensive experience with regulatory filings such as IND, IMPD, NDA, MAA.
• Strong knowledge of ICH, FDA, EMA guidelines for oligonucleotide QC.
• Ability to lead cross-functional teams and communicate effectively.

Responsibilities

• Lead late-stage AD&QC activities for oligonucleotide programs.
• Author and review regulatory submissions (IND/IMPD/NDA/MAA).
• Ensure regulatory inspection readiness and support health authority interactions.
• Collaborate with DS/DP Development, QA, and Regulatory Affairs.

Skills

AD&QC expertise

Regulatory submissions

cGMP knowledge

Cross-functional collaboration

Education

PhD in Organic Chemistry or Analytical Chemistry

Job description

Entrada Therapeutics in Boston, MA, is seeking an Associate Director, Analytical Development & Quality Control to lead late-stage AD&QC activities, manage regulatory submissions, and ensure GMP compliance for oligonucleotide programs.

You will collaborate with CMC SMEs, QA, Regulatory, and CDMOs, support IND/IMPD/NDA/MAA filings, and help readiness for inspections, with a US-based remote role requiring periodic travel to the Boston headquarters.