Vice President, Technical Operations

Position Summary

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.

Key Responsibilities

• CMC Strategy & Regulatory Leadership

  • 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 recalls

• CDMO Oversight

  • 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

• Quality and Compliance

  • 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

• Leadership, Strategy & Resource Management

  • 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

Qualifications

• Education & Experience

  • 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

• Technical Competencies

  • 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

• Leadership & Organizational Skills

  • 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

Salary Range

$293,000 - $358,000 USD