This position is responsible for the development of robust and stable formulations and manufacturing processes for clinical and ultimately commercial stage for our proprietary recombinant adeno-associated virus (AAV) gene delivery products. Responsibilities include development of formulations appropriate for the stage of product life-cycle, product characterization, tech transfer of fill-finish processes to external manufacturing sites, and authorship of relevant regulatory documents. The successful candidate is expected to work independently on assigned projects, provide insights to impact formulation and manufacturing strategy, prioritize projects to meet departmental and organizational goals, and to communicate plans and results to Technical Operations management.
Design and execute scientifically rigorous formulation screening, development, stability, and characterization studies to select stable formulations for our proprietary recombinant AAV gene delivery products.
Perform laboratory studies to develop and characterize formulations and processes, using dynamic light scattering, HPLC, spectrophotometry, differential scanning calorimetry, lyophilization, and Karl Fischer titration.
Generate protocols and reports on the experimental work and deliver progress presentations at the team and department level.
Design and execute studies to characterize Drug Product processes utilizing QbD principles in support of transfer of process steps to external CMOs for both clinical and late stage programs.
Provide support for cGMP manufacturing and review of Batch Records.
Author technical reports, including data interpretation suitable for inclusion in INDs, BLAs, and equivalent regulatory submissions.
Collaborate with manufacturing, process development, and analytical groups to coordinate BDS-DP interface and material needs.
Collaborate within organization to ensure final labelled product and clinical procedures are in-line with product requirements and target product profiles.
Keep current with advances in formulation development for AAVs and fill-finish processing, including relevant conference attendance.
Support smooth laboratory operations including instrument and supplies management.