Vice President, Technical Operations

Remix Therapeutics•Watertown, MA

13d•$293,000 - $358,000

About The Position

Remix Therapeutics is seeking an experienced and strategic Vice President, Technical Operations to lead the Company's CMC strategy, building and managing a high-performing Technical Operations organization, and overseeing the external manufacturing and supply network required to support late-stage development and future commercial supply of REM-422. This role offers a unique opportunity to shape the operational foundation of a growing biotechnology company at a pivotal stage of development. The successful candidate will cultivate strategic partnerships with CDMOs, implement scalable operational processes, and establish the standards, systems, and capabilities necessary to support long-term growth. As a member of the Clinical Leadership Team, the Vice President will serve as a key strategic partner across Regulatory Affairs, Quality, Clinical Development, and Executive Leadership, driving operational excellence and enabling the successful delivery of therapies to patients with adenoid cystic carcinoma (ACC) and other serious diseases.

Requirements

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
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
Experience authoring and defending CMC sections of global regulatory submissions; direct experience leading or preparing for FDA and/or EMA health authority meetings strongly preferred
Strong understanding of change control, deviation management, CAPA systems, data integrity principles, and GMP inspection management
Broad technical fluency across analytical sciences, stability, comparability, and process validation/PPQ planning
Proven ability to build, scale, and lead Technical Operations teams in resource-constrained biotech environments; track record of recruiting and developing high-performing talent
Strategic thinker and hands-on operator — equally comfortable setting long-term direction and driving day-to-day execution against program milestones
Exceptional cross-functional collaborator with trusted partnerships across Regulatory Affairs, Quality, Clinical, and Finance
Clear, concise communicator who translates complex technical issues for executive and Board audiences and drives alignment through data and sound judgment
Thrives in fast-paced, milestone-driven environments; highly independent, organized, and effective managing multiple priorities simultaneously

Responsibilities

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
Define and execute a phase-appropriate control strategy, including process and analytical method development, stability programs, specification-setting, PPQ/validation pathway and commercial supply continuity and compliance in alignment with ICH guidelines
Lead the preparation, authoring, and review of CMC sections for global regulatory submissions including INDs, CTAs/IMPDs, and NDAs/MAAs; 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
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; cultivate strategic partnerships with CDMOs and CMOs through Quality/Technical Agreements (QTAs/TTAs), performance audits, and KPI-driven oversight; oversee product supply chains to ensure continuity and quality
Serve as primary technical and operational escalation point for CDMO relationships; ensure best-in-class capabilities, on-time delivery, and alignment with Remix's quality and regulatory standards
Review and approve technical documentation, and other CDMO outputs
Partner with Quality Assurance to maintain robust cGMP compliance across internal and external operations, including batch records, change control, deviations/CAPA management, data integrity, and inspection readiness
Ensure Technical Operations practices are audit-ready at all times; lead or support regulatory inspections (FDA, EMA) as needed
Build and lead a high-performing Technical Operations team; attract, develop, and retain top talent; foster a culture of accountability, scientific rigor, collaboration, and urgency
Govern the Technical Operations budget; model trade-offs across throughput, COGS, yield, and capital investments; present data-driven recommendations to executive leadership and the Board
Serve as an influential voice on the Development Leadership Team, ensuring Technical Operations is a strategic enabler of Remix's clinical and commercial success