Latitude, Inc. CMC Lead in Rockville, Maryland
Overall responsibility for developing the analytical strategy from preclinical development through commercial
Develop and implement a strategy for the identification, selection, and management of Contract Development Manufacturing Organizations (CDMOs) for process/formulation development, cGMP manufacture, and supply of Clinical trial materials (CTMs) for clinical development programs.
Formulation design/development to support clinical programs.
Direct the writing and reviewing documents for INDs and other regulatory section submissions; represent the company as the CMC expert before the U.S. and other regulatory authorities.
Work closely with the CSO and CMO to build and lead an interdisciplinary research program by collaborating on establishing scientific strategies, defining research goals and execution of new research projects
Contribute to the production of project-related documents, budgets, presentations, patents and regulatory submissions as required.
Minimum of BS in biochemistry or related discipline
Knowledge of CMC development from pre-clinical to clinical to commercialization