Summary of Position:

Reporting to the SVP, CMC the Vice President, CMC will be responsible for providing strategic direction, technical leadership, and operational execution for ensuring successful CMC development activities for ReCode programs. This position partners with CMC, Pre-clinical and Clinical functions and global CMO partners to provide technical leadership, direction and timely execution.

Responsibilities:

• This hands-on position will support all CMC aspects of development, including process chemistry, route optimization, GMP manufacture and clinical supply, and formulation development
• In this role, the CMC leader will manage multiple priorities in a fast-paced environment, enact quick problem solving to ensure uninterrupted supply of drug for IND-enabling activities including toxicology studies, as well as clinical trials
• Oversees outsourced manufacturing, including technology transfer, quality control and product/process development activities for drug candidates from late-stage preclinical development through commercialization
• Identifies, diligences and selects Contract Manufacturing Organizations (CMOs) for process optimization, formulation work, GMP manufacture and supply
• Formulates drug substance and drug product development strategy to meet clinical and commercial needs, ensure product quality, facilitate regulatory approvals and achieve operational flexibility of supply chain
• Coordinates with Quality Assurance, when applicable, to implement stage-appropriate GMP processes
• Write and/or review CMC sections of regulatory documents and submissions; represent ReCode as the CMC expert in front of regulatory authorities
• Establish and maintain detailed project plans; define risks and continually evaluate ways to optimize timelines and parallel process while appropriately managing risk
• Establish phase-appropriate process development and formulation strategies for each drug program
• Remain current on Health Authority guidance and expectations and contribute to regulatory strategy and submissions

Qualifications:

• Advanced degree in chemical or biological sciences
• 8+ years of biopharmaceutical industry experience
• Significant experience working with external CROs/CMOs
• Extensive experience with manufacturing, Formulation/Drug Product Development, and Analytical Development
• Understanding of cGMP compliance requirements associated with U.S., EU, ICH and other pertinent regulatory agencies

Competencies:

This position requires the following competencies, but is not limited to:

• Technical Expertise
• Managing Change
• Communication
• Driving for Results
• Collaboration/Teamwork
• Innovation/Creativity

Salary Range: 310-330k*

• Please note that for remote positions, salary may be adjusted for cost of living