Remix Therapeutics

Vice President, Technical Operations

Watertown, MA · Exec

Sponsorship not specified$12k-$18kDetected 40 days ago

GMPFDA RegulatoryLeadershipCollaborationRegulatory Affairs

About the role

This role offers a unique opportunity to shape the operational foundation of a growing biotechnology company at a pivotal stage of development.

Own and drive the CMC lifecycle management for clinical candidate REM-422 and pipeline programs, ensuring alignment with program milestones, corporate objectives, and commercial timelines
Lead the preparation, authoring, and review of CMC sections for global regulatory submissions including INDs, CTAs/IMPDs, and NDAs/MAAs
Partner with CEO, Regulatory Affairs and Quality Assurance to assist with corporate responses to marketed product defects or recall
Select and build Remix's external manufacturing network

Deep expertise in small molecule drug development, including process chemistry, formulation development, analytical method development and validation, and regulatory CMC
Comprehensive knowledge of cGMP regulations (21 CFR Parts 210/211, EU GMP), ICH Q-series guidelines, and phase-appropriate CMC expectations across IND through NDA
Proven expertise in CDMO selection, oversight, and governance in an externalized manufacturing model
strong track record managing complex multi-site supply chains
Ph.D. or M.S. in Chemistry, Pharmaceutical Sciences, Chemical Engineering, Biochemistry, or a related discipline
12-18+ years of progressive experience in CMC/Technical Operations within the pharmaceutical or biotechnology industry, including leadership roles at a small or mid-size company navigating late-stage clinical development and commercial readiness
Demonstrated track record driving Technical Operations through Phase 2/3 clinical development toward commercial launch; pre-commercial or commercial launch experience strongly preferred
Proven expertise in CDMO selection, oversight, and governance in an externalized manufacturing model; strong track record managing complex multi-site supply chains

Demonstrated track record driving Technical Operations through Phase 2/3 clinical development toward commercial launch
pre-commercial or commercial launch experience strongly preferred

Remix launched with a vision to transform patients' lives through modulation of RNA processing.
We focus on diseases of high unmet medical need and are committed to operating with scientific rigor and urgency.
serve as primary CMC lead in meetings with Health Authorities in the US and ex-US
Partner with Regulatory Affairs on CMC strategy, submission timelines, and Health Authority interactions to ensure alignment and on-time delivery of regulatory packages

This listing is sourced directly from Remix Therapeutics's careers page and normalized into a canonical job model.