Associate Director/Director - GMP, CDMO Vendor Management

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:

ReCode Therapeutics is growing and looking to add an Associate Director/Director – GMP, CDMO Vendor Management to our CMC team. In this role, you will be responsible for providing leadership, strategic planning, and establishing and managing ongoing relationships with our CDMO partners. You will also work with our cross-functional product development team including Formulation Development, mRNA Process Development, Analytical Development, Clinical Operations, Regulatory Affairs and Quality in the development and commercialization of gene therapy drug products.

Responsibilities:

• Manage and oversee work conducted at CDMOs, conducting tech transfer activities and site visits to ensure compliance training of personnel.
• Perform qualification of CDMOs and related vendors in support of drug substance, critical excipients and drug product manufacturing
• Review technical documents including batch records, specifications, stability protocols, change controls, deviations analytical methods transfer, qualification, and other documentation that is required for manufacture ReCode products.  Facilitate timely documentation approval
• Manage priorities and timelines and ensure deliverables are met according to project timelines
• Work closely with all CMC departments and Quality
• Keep abreast of industry trends and developments, current practices, and regulatory guidance
• Provide presentations, updates, and recommendations as necessary to senior management
  

Qualifications:

• Ph.D. and 5+ or MS and 10+ or BS and 12+ years of experience in chemical engineering, bioengineering, chemistry, or a related discipline.
• Background in GMP manufacturing in the biopharma industry
• Extensive knowledge of cGMP requirements and regulatory CMC
• Excellent communication and interpersonal skills, with demonstrated ability to build and maintain effective and collaborative relationships with internal and external stakeholders.
• Strong problem-solving and decision-making skills with the ability to identify and manage project risks.
• Ability to work independently and handle multiple projects simultaneously.

As a bonus:

• Knowledge of lipids, small molecules, nanoparticle drug products, liposomal products, nucleic acid chemistry and biology and standard methods of analysis of these molecules.
• Proficiency with Quality by Design (QbD) concepts, DoE, statistical process control (SPC) and complex data analysis.

Salary Range: 

175k-205k - *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.