Director - Process Development

The responsibilities of this role will be to oversee and lead process development and scale up of mRNA drug substances from few hundred milligram to multigram to kg 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 a cross-functional product development team including Formulation Development, Process Development, Production, Clinical Operations, Regulatory Affairs, and Quality in development and commercialization of gene therapy drug products.

 Responsibilities:

·        Provide leadership in development and characterization of the upstream and downstream manufacturing processes to produce mRNAs for company developmental drug products

·        Provide science-based approach to upstream process and purification steps characterization and optimization, determine the effect of process parameters reagents and equipment used on mRNA yield and critical quality attributes

·        Scale up mRNA production to stage-appropriate scales

·        Establish robust unit operations and verify process design space to define process control strategies that facilitate commercial scale manufacturing

·         Work with drug product process development, formulation and analytical development in developing drug products that are well characterized, stable and highest quality

·        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

Qualifications:

·        Minimally possess a Ph.D. in biochemistry, molecular biology, bioengineering or a related discipline with 5+ years of directly relevant industry experience. Comparatively, a candidate possessing an MS in biochemistry, molecular biology, bioengineering or a related discipline with 10+ years of directly relevant industry experience will be considered 

·        5+ years of industry experience with biological molecules process development required; mRNA preferred

·        Biological molecule upstream and downstream scale-up experience required

·        Process development experience with cell-free manufacturing of biological molecules is a plus

Proven experience working in a GMP and regulatory CMC environment.

·        Strong collaborator with cross-functional teams and external partners