Lead Formulation Scientist

JOB DESCRIPTION

* Responsible for establishing a robust program for identifying new opportunities which addresses unmet clinical or market need with branded drugs
* Determine feasibility of overcoming the technical challenges related to the new opportunities identified
* Provide the necessary technical support (formulation/analytical) for pre-IND or any other meetings with the FDA
* Lead opportunities that are identified through product development at company laboratories and transfer the technical information to manufacturing site for exhibit/clinical batch manufacture and provide any assistance during batch manufacture
* Provide the necessary support required for regulatory filing with the FDA
* Assist in responding to CMC deficiencies from FDA
* Support technical due diligence audits conducted by existing and potential partners

JOB REQUIREMENTS

* PhD in Pharmaceutics with at least 5+ years experience in injectable product development
* Working experience with development of injectable solutions and lyophilized injectable products. Experience with other dosage forms such as injectable suspensions and emulsions is a plus

* Experience in transfer of technical process information to manufacturing sites
* Excellent technical writing skills (Feasibility reports on new opportunities, technical due diligence supportive documents, experimental protocols, development reports, and technology transfer reports)
* Ability to work independently with minimal supervison
* Experience in both brand and generic industry is a plus