We are Aclaris Therapeutics – committed to meeting the needs of patients with skin and hair conditions with innovative treatments that define new standards of care in dermatology and immunology. Reporting to the SVP of Pharmaceutical Research and Development, the Sr. Director of Chemical Development will be responsible for the design and implementation of phase appropriate API supply strategies to support the Aclaris Early Development Portfolio.
The selected candidate will lead the transition of synthetic routes from Discover Chemistry Teams to deliver scalable processes to support initial GMP manufacture of API for Phase I/II clinical trials and support the technical transfer of processes as the projects transition towards validation, product registration, and commercialization.
The ideal candidate will ensure that all development and manufacturing activities are conducted in a manner consistent with regulatory requirements while integrating quality by design and quality risk management principles into the development of the API process.
Through the development of synthetic novel routes, and/or improving existing routes, the CMC lead will also develop stage appropriate analytical methods, and oversee contractor relations, chemical and analytical development, and the manufacture and supply of API’s for production of clinical trial materials (CTM).
What We Provide:
At Aclaris Therapeutics, we are proud to offer if eligible, a highly competitive compensation plan with an excellent benefits package including the following:
St. Louis, MO or Wayne, PA
Aclaris Therapeutics, Inc. is an Equal Opportunity Employer - Minorities/Women/Protected Veterans/Disabled - Proudly embracing diversity.