ENGINEER - LNP PROCESS DEVELOPMENT
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 perform process development and scale up of lipid nanoparticles (LNPs)-RNA drug products from bench scale to liters scales. In addition, the incumbent will be involved in design of production equipment at different scales and developing cleaning and sterilization processes. The ideal candidate will be involved in developing batch records and SOPs to manufacture batches for GLP toxicology and clinical studies under GMP. The candidate will work within cross-functional product development team including Formulation Development, mRNA Process Development, Analytical Development, Engineering and Quality in development and commercialization of gene therapy drug products.
HERE’S SOME OF WHAT YOU’LL DO
- Design and execute experiments for upstream and downstream manufacturing processes to produce LNPs-RNAs developmental drug products.
- Identify and characterize critical process parameters
- Involved in equipment design for scale up LNPs-mRNA production to required scales, for both clinical development and commercial
- Design and develop cleaning and sterilization processes for equipment train
- 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 the commercial scale manufacture
- Prepare SOPs and batch records to manufacture drug products when needed for GLP toxicology and clinical studies
- Summarize and present data, author development reports and provide recommendations to product development teams
HERE’S WHAT YOU’LL BRING
TO THE TABLE
- Minimally possess a Ph.D. in chemical engineering, bioengineering, chemistry, or a related discipline with 2+ years of directly relevant experience. Comparatively, a candidate possessing an MS in chemical engineering, bioengineering, chemistry, or a related discipline with 7+ years of directly relevant experience will be considered
- Minimum of 2 years of successful experience in developing and scaling drug product formulation and fill finish processes
- Experience with cleaning and sterilization processes and their principles
- Process development of liposomal, LNPs, or similar lipid-based drug products
- Experience in product manufacturing for clinical development
- Knowledge of lipids, small molecules, nanoparticle drug products, liposomal products, nucleic acid chemistry and biology and standard methods of analysis of these molecules preferred; Experience with lipid nanoparticle formulations, tangential flow filtration technologies, and the scaling of mixing operations strongly preferred
- Understanding of the in-vitro and in-vivo experiments and assays used for screening candidate formulations is preferred
- Proficiency with Quality by Design (QbD) concepts, DoE, statistical process control (SPC) and complex data analysis.
- Strong collaborator with cross-functional teams and external partners
ReCode Therapeutics (www.recodetx.com) offers a competitive compensation/benefits with a friendly, collaborative culture that values employee engagement and ongoing career development. ReCode Therapeutics is an Equal Opportunity Employer.