Vice President, Technical Operations

Vice President, Technical Operations

Watertown, MA

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.

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 recall

• 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

This range reflects the expected base salary for this position, plus bonus, equity, and benefits as applicable. Actual salaries may vary based on factors, such as skill, experience, and qualification for the role.