DEA Compliance Manager
Seeking candidates who have experience working with DEA regulations. Successful candidate will have background in all State and Federal controlled substance regulations, will be able to develop and maintain program (policies, procedures); have ability to evaluate all related procedures to ensure security requirements are being met; ability to train all personnel; submit and track reports required by the DEA and State Agencies. Will complete and file ARCOS reporting, submit and track Forms 222, 161 and 236, procure and maintain all registrations and authorizations. Oversee and maintain physical inventories of controlled substances.
Education Required is: BS/BS and minimum of 5 years of DEA compliance experience.
Analytical Chemist I
Successful candidate will be a key contact for development and validation of analytical methods in support of in-process control, release of APIs, and stability studies, have deep understanding of separation science, general chemistry, GMP, ICH guidelines and Compendial testing procedures is required. The Analytical Chemist will plan and organize work with minimal supervision, coordinate analytical activities to meet project time lines, analyze data, interpret results, and write technical reports. The preferred candidate would be proficient in HPLC, GC, IC, IR, KF, etc. Experience in LC-MS, GC-MS, NMR, and prep-LC operations for impurities isolation and identification is a plus. Education required is as follows: B.S. degree with 5 years’ experience, M.S. with 3 years’ experience, Ph.D. with 1 year experience.
Apply to llebrasseur -at- cedarburgpharma.com. Submit resume and cover letter with salary history. EOE.Good luck!