Who We Are:
We are an integrated genetic medicines company developing targeted, disease-modifying medicines for patients with life-limiting diseases. Our treatments address the underlying genetic cause in underserved populations and have the potential to tremendously impact the quality and length of patients’ lives.
At ReCode, we bring a unique blend of rigor, creativity, and curiosity to our high-hurdle mission: harnessing our multi-platform approach to develop disease-modifying medicines. Our team is uniquely positioned to tackle this challenge, given our extensive experience in mRNA design and optimization, delivery technologies, mRNA manufacturing, gene editing, and rare disease drug development.
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.
- 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
- 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
This position requires the following competencies, but is not limited to:
- Technical Expertise
- Managing Change
- Driving for Results
ReCode Therapeutics (www.recodetx.com) offers a competitive compensation/benefits package with a friendly, collaborative culture that values employee engagement and ongoing career development.
ReCode Therapeutics is an Equal Opportunity Employer.