Formulation Leader

Celgene Corporation is a global integrated biopharmaceutical company primarily engaged in the discovery, development and commercialization of innovative therapies designed to treat cancer and immune-inflammatory related diseases in patients with limited treatment options.

This position is responsible for formulation design, development, and characterization, and technology transfer to enable early phase clinical manufacture of small molecule drug products (DPs) for clinical development of new pharmaceutical products.

* Key member of a dynamic scientifically driven team, dedicated to the design, development, and characterization of robust small molecule drug product formulations. * Serve as Drug Product Development representative on multidisciplinary CMC teams. * Develops oral and parenteral formulations for early phase clinical studies. * Evaluates the need and potential for enhancing oral bioavailability of drug candidates through appropriate formulation strategies. * Responsible for the design and execution of experiments to characterize drug product formulations and manufacturing processes utilizing various technologies. * Lead the identification, development, and deployment of new instrumentation, technologies, and methodologies to support efficient and effective drug product formulation development. * Manage formulation development/technology transfer to Contract Research/Manufacturing Organizations. * Prepare CMC regulatory documents. * Serve as a resource of scientific and technical expertise. * Coach and develop scientists/engineers under a project specific matrix team. * Assume departmental responsibilities for assigned projects and equipment. * Maintain safety, regulatory, and compliance standards as they relate to the development of pharmaceuticals. Prepare technical reports, publications and oral presentations.

**Prerequisite:** * Ph.D. with minimum of 6 years experience in Pharmaceutics, Pharmaceutical Science or related field; or * M.S. with minimum of 8 years experience in Pharmaceutics, Pharmaceutical Science or related field; or. * B.S. with minimum of 10 years in Pharmaceutics, Pharmaceutical Science or related field. **Skills/Knowledge Required:** * Strong background in pharmaceutical development as it relates to preformulation, formulation development, and process development. * Demonstrated expertise in leading formulation design, development, and characterization, and technology transfer to Contract Research/Manufacturing Organizations. * Experience with solid oral dosage formulations (IR/MR) and solubility enabling technologies. Experience with parenterals is a plus. * Strong fluency in biopharmaceutics. * Demonstrated capability orchestrating development and execution of an experimental program to address issues of composition, stability, bioavailability, and manufacturability, integrating efforts with specialists in other technical disciplines. Demonstrated record of implementing novel and creative solutions to overcome formulation development obstacles. * Knowledge of cGMPs during pharmaceutical development and clinical manufacturing. * Demonstrated proficiency in balancing resource requirements within projects and among multiple assigned projects. * Strong interpersonal skills and the ability to work in a fast paced, multidisciplinary environment. Ability to work independently or in leading a team under deadline. Strong verbal and written communication skills are essential. * Experience with broad CMC issues encountered in drug development, thorough understanding of applicable regulations, and experience with authoring relevant sections of regulatory filings (INDs/NDAs). * Ability to supervise, coach, and mentor junior-level scientists.