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Director, Small Molecule Analytical Development

Our client is a biopharmaceutical company dedicated to bringing biotech ingenuity to medical dermatology. They are focused on delivering important new therapies to the millions of patients living with chronic skin conditions. They strive to help transform the way skin conditions are treated by serving as the bridge between unmet patient needs and the significant scientific advances being made in understanding skin biology.

The Director of Analytical Development will be responsible for managing analytical activities at CMOs / CTLs asin support of drug product manufacturing. They are expected to apply technical proficiency to the planning and execution of analytical activities at CMOs / CTLs, and independently be able to problem solve and make decisions.

Must Have's:

-M.S. in Organic Chemistry or Related (PhD preferred)

-5+ year's hands on lab experience

-10 year's industry experience

-Extensive knowledge of cGMP requirements, ICH, FDA, USP and other regulatory guidelines

-2-5 years CMO management experience

Like-to-Have's:

-Experience with regulatory writing including but not limited to: IND and NDA submissions

-Broad experience of lab and CMO management

Responsibility:

Provide management and technical support to multiple CMOs. Apply technical and managerial expertise to a well established team to meet on project goals, timelines, and strategic decisions. In addition, this position will support the drug substance department. These tasks include: method development, method validation, data review, method and tech transfer, and troubleshooting. This role will also have a large part in tracking and trending stability data and studies. For the development programs, they will be interpreting chromatographies, tracking stability, and developing formulations. In addition, this position will play a key role in the support of regulatory submissions including INDs and NDAs.

Sthree US is acting as an Employment Agency in relation to this vacancy.