We are seeking a leader responsible for the oversight of formulation development, sterile fill-finish process development, scale-up, tech transfer and manufacture of targeted lipid nanoparticles (tLNPs) for pre-clinical and clinical studies.  The successful candidate should demonstrate his/her ability in establishing and leading a growing formulation team and will work seamlessly with external manufacturing organizations to complete GMP testing. In addition, the incumbent will be expected to establish systems in the department to enable manufacturing of the batches for non-clinical safety studies and clinical studies under GMP. The candidate will oversee work on a cross-functional product development team including liaising with Biologics CMC, Synthetic Molecule CMC, Clinical Operations, Regulatory Affairs including addressing requests for Health Authorities, and Quality Assurance in development and commercialization of drug products.  

Responsibilities:

• Responsible for overseeing formulation development of targeted lipid nanoparticles (tLNPs) entering FIH, as well as formulation optimization and commercial formulation definition prior to pivotal clinical trials. 
• Responsible for evaluation of novel product presentations for tLNPs, which may include a lyophile, spray dried powder, nonaqueous suspension, or other advanced presentations, and the process development thereof. 
• Designs, oversees, and reviews clinical in-use studies to evaluate the stability and compatibility of tLNP drug products. 
• Manages contract development and manufacturing organizations (CDMOs) involved in sterile fill finish operations of tLNPs. 
• Reviews and approves documents related to formulation development and drug product production, including technical transfer, process development reports, qualifications, master and executed batch records, and campaign summary report. 
• Works closely with others in CMC and quality assurance to lead investigations and data analysis to address deviations/non-conformance and implement change controls to ensure timely/prompt release of batches. 
• Authors and reviews drug product sections for regulatory submissions. 
• Contributes to the development and monitoring of departmental goals and budgets.