Backed by 5AM Ventures.
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. Found on 1752vc Careers, the job board for startup and VC roles.
What they're looking for
- 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
- 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
More about this role
What's happening at Entrada Therapeutics? 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 that have long been considered inaccessible. Through proprietary and versatile approaches, Entrada is advancing a robust development portfolio of genetic medicines for the potential treatment of neuromuscular and inherited retinal diseases, among others. Our lead oligonucleotide programs are in development for the potential treatment of people living with Duchenne muscular dystrophy (DMD) who are exon 44, 45, 50 and 51 skipping amenable. Entrada has partnered with Vertex Pharmaceuticals to develop a clinical-stage program, VX-670, for myotonic dystrophy type 1 (DM1).
2026 represents a catalyst-rich period for Entrada. We expect multiple clinical data readouts as we advance several DMD programs across the U.K., EU, and U.S. By year-end 2026, we anticipate four clinical-stage programs in our DMD franchise (ENTR-601-44, ENTR-601-45, ENTR-601-50, and ENTR-601-51). These programs are complemented by the ongoing clinical progress of our DM1 collaboration with Vertex...
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