CMC Manager-The CMC Manager provides oversight of the research efforts of the CMC team in the Pharmaceutical Develop Group and evaluates the resources needed to meet the project expectations for CMC support and anticipate gaps so the projects are not delayed. The CMC Manager will formulate a plan for building the CMC section for each project and will coordinate internal and external efforts to assure the CMC needs are met.
The CMC Manager will work with the Research and Development team to establish the studies needed to support the CMC section and will coordinate with formulation and analytical to oversee the process of issuing protocols, generating and evaluating data and producing reports. The CMC manager will participate in the process of issuing protocols, generating and evaluating data and producing reports to support the CMC.
Qualifications include excellent organization skills, understanding of FDA regulated practice and work toward being recognized as a CMC expert. Must be proficient in MS Office applications software. The successful candidate will have a high level of autonomy in interpreting the requirements for studies as described in the guidelines or other publications. The successful candidate will need to be able to communicate the project needs effectively. A B.S or equivalent degree in Chemistry, Engineering or related science is required along with 10 years of experience in a chemistry related field and 4-6 years of experience in a supervisory or management role.
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