Vice President, CMC

Who We Are:

We are a clinical stage company powering the next wave of genetic medicine through superior delivery with our next-generation lipid nanoparticle delivery platform. Our mRNA and gene editing therapeutics have the potential to directly replace or address underlying genetic mutations in a vast range of diseases starting with primary ciliary dyskinesia and cystic fibrosis. Our selective organ targeting (SORT) LNP platform is uniquely differentiated to enable the delivery of diverse genetic payloads to tissues beyond the liver.

At ReCode, we bring a unique blend of rigor, creativity, and curiosity to our high-hurdle mission. Our team is uniquely positioned to tackle this challenge, given our extensive experience in lipid nanoparticle delivery, mRNA design and optimization, mRNA manufacturing, gene editing, and rare disease drug development. We are a high performing, highly functional organization with a culture that is caring and strives to enable every member of our team to thrive.

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

Benefits Offered:

• No premium cost for employees - 100% subsidized by ReCode for full-time employees
• Company 401k contribution
• 15 days of company paid holidays, including a holiday shutdown (usually the last week of the year)
• Mental health support for employees & their families
• FSA available, including a lifestyle spending account subsidized by company
• Employee discounts at hotspots

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.