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Latitude, Inc. CMC Lead in Rockville, Maryland

Responsibilities

  • 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.

Requirements:

  • Minimum of BS in biochemistry or related discipline

  • Knowledge of CMC development from pre-clinical to clinical to commercialization

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