Principal Scientist / Associate Director, Drug Product Development

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 is growing and seeking a Principal Scientist / Associate Director, Drug Product Development to join the CMC team. In this role, you will be responsible for the development and optimization of formulation development activities of lipid nanoparticles / RNA-based product candidates for preclinical and clinical development. You will work within cross-functional product development teams to develop and commercialize drug products. This position is based onsite in our Menlo Park, CA location.

Responsibilities:

• Lead formulation development, fill/finish process development, lyophilization, advanced biophysical characterization, and tech transfer activities for LNP/mRNA drug product candidates in development
• Design and execute detailed experiments to develop and optimize LNP formulations using risk assessments, appropriate scale down models and Quality by Design (QbD) principles
• Provide direct leadership and technical mentorship to a team of scientists/engineers
• Collaborate closely with cross-functional teams, including Process Development, Analytical Development, and Quality, to ensure seamless integration of drug product development activities.
• Analyze and present data, contribute to the authoring of development reports and provide recommendations to product development teams.
• Support the preparation of relevant sections for IND submissions, regulatory dossiers, and responses to inquiries from regulatory agencies.

Qualifications:

• Ph.D. in chemistry, bioengineering, chemical engineering, or a related discipline with 5+ years of directly relevant industry experience or an MS in chemistry, bioengineering, chemical engineering, or a related discipline with 8+ years of directly relevant industry experience will be considered. 
• 5+ years of formulation and product development experience with drug delivery systems, lipid-based products, biophysical, and small-scale process techniques.
• Hands-on experience with LNPs, liposomes, nanoparticles, other lipid-based drug delivery systems or AAV/viral vectors is required.
• Understanding of the in-vitro and in-vivo experiments used for screening for candidate formulation required.
• Ability to establish and maintain effective working relationships with coworkers, managers and clients – many with diverse cultural backgrounds
• Outstanding communication skills; comfortable representing the company and vision to internal and investor communities.
• Confident, independent and decisive; a self-starter, proactive and results-oriented with high performance standards. Passionate, persistent and tenacious. Strong ability to prioritize and operate with a sense of urgency.
• “Hands-on”, “roll-up-the-sleeves” contributor who understands the need for involvement at all levels of activity within a small company environment. Extremely bright with a highly strategic nature but also balanced with a biotech mindset and an attitude that gets things done.
• Understanding of and willingness to meet applicable regulatory, quality and compliance standards. Trustworthy with highest integrity, committed to ethics and scientific standards.

Salary Range: *180-185K

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

Benefits Offered for Full-Time Employees: 

• 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.