Serve in a leadership and project management role in the Analytical Development department and perform a wide variety of functional, cell-based, binding assays for characterization, stability and release testing of drug substances and drug products, and perform method qualifications and validations. Responsibilities include the following:
Execution and Completion of correlative studies for the binding and potency for the new programs using SPR.
Execution of stability and drug product characterization assays for marketed and development products.
Serving as the program representative for bioassay group for assay transfers of internal and external groups for GMP and release testing.
Guide teams in Contract Research Organizations for better support of Momenta programs.
Serve as the analytical functional characterization team member for CMC groups.
Give guidance, presentations, trainings to development group scientists for binding and cell based assays.
Draft technical procedures, protocols, guidance documents, and author sections of regulatory documents for drug license applications.
Must have MS in Biotechnology or related technical field and 4 years of hands-on industry experience with in GXP environment that includes SPR and cell-based Assay Development or Assay Validation and developing new methods, techniques and evaluation criteria.