Formulation Scientist - (West Lafayette, IN)

Responsibilities Required functions: Manage all aspects of formulation development including regulatory documentation creation, pre-formulation, formulation development, process scale up coordination, data analysis /reporting writing and regulatory documentation generation. Follow all applicable state and federal laws regarding the operation of a pharmaceutical facility. Responsible for all aspects of pharmaceutical development equipment. Understand and implement all aspects of 2011 FDA Guidelines for Process Validation. Additional Responsibilities: Demonstrate technical proficiency in solid and liquid formulation development and adherence to cGMP and ICH compliance. Serve as formulation development lead or delegate to other staff as appropriate regarding formulation development projects teams and product operational teams. Collaborate with regulatory to support IND filling/amendments on CMC section. Evaluate, justify, recommend and purchase development equipment and supplies.