DIRECTOR – PROCESS DEVELOPMENT (Drug Products)
We are an integrated genetic medicines company developing targeted, disease-modifying medicines for patients with life-limiting respiratory 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 RNA delivery technologies, protein structure, tRNA biology, mRNA manufacturing, gene editing, and drug development.
The responsibilities of this role will be to oversee and lead process development and scale up of lipid nanoparticles (LNPs)-RNA drug products from bench scale to liters scales. In addition, the incumbent will be expected to establish systems in the department to enable manufacture of the batches for GLP toxicology and clinical studies under GMP. Also, in this role the candidate will work within cross-functional product development team including Formulation Development, mRNA Process Development, Analytical Development, Clinical Operations, Regulatory Affairs, and Quality in development and commercialization of gene therapy drug products.
HERE’S SOME OF WHAT YOU’LL DO
- Provide leadership in development and characterization of the upstream and downstream manufacturing processes to produce LNPs-RNAs drug products.
- Provide expertise and oversee equipment design for scale up LNPs-mRNA production to required scales.
- Provide science-based approach to upstream process, purification steps characterization and optimization, determine the effect of process parameters, reagents and equipment used on product yield and critical quality attributes.
- Establish robust unit operations and verify process design space to define process control strategies that facilitate commercial scale manufacturing.
- Establish required quality systems, SOPs and batch records to manufacture mRNA when needed for use in GLP toxicology and clinical studies.
- Prepare appropriate eCTD sections for regulatory submissions.
- Responsible for managing a department, hire, train and coach staff.
- Summarize and present data, author development reports and provide recommendations to product development teams.
- Some hands-on work in the lab is expected
HERE’S WHAT YOU’LL BRING TO THE TABLE
- Minimally possess a Ph.D. in chemical engineering, bioengineering, chemistry, or a related discipline with 5+ years of directly relevant industry experience. Comparatively, a candidate possessing an MS in chemical engineering, bioengineering, chemistry, or a related discipline with 10+ years of directly relevant industry experience will be considered.
- 5+ years in industry successfully developing and scaling bulk product manufacturing processes and fill / finish processes
- Experience with liposomes or lipid nanoparticle formulations, tangential flow filtration technologies, and the scaling of mixing operations preferred
- Experience in manufacture products for clinical development
- Proven experience working in a GMP and regulatory CMC environment
- Strong collaborator with cross-functional teams and external partner
ReCode Therapeutics (www.recodetx.com) offers a competitive compensation/benefits friendly, collaborative culture that values employee engagement and ongoing career development. ReCode Therapeutics is an Equal Opportunity Employer.