Manager, Drug Enforcement Administration

Manager, Drug Enforcement Administration

Catalent, Inc. is a leading global contract development and manufacturing organization (CDMO) whose mission is to develop, manufacture, and supply products that help people live better and healthier lives. Catalent is dedicated to delivering unparalleled service to pharma, biotech, and consumer health customers, supporting product development, launch, and full life-cycle supply. With time-tested experience in development sciences, delivery technologies, and multi-modality manufacturing, Catalent supports the acceleration of development programs and the launch of more than a hundred new products every year. Powered by thousands of scientists and technicians and the latest technology platforms at more than 40 global sites, Catalent supplies billions of doses of life-enhancing and life-saving treatments for patients annually.

This is a full-time salaried position, based out of our Kansas City, MO site. The Manager, Drug Enforcement Administration will oversee the state of DEA regulatory compliance of controlled substances at the Kansas City, MO site through the following : oversee the inventory and other aspects regarding the use and storage of controlled substances in pharmaceutical dosage forms in development, laboratory, manufacturing, and packaging environments. The Manager, Drug Enforcement Administration will support all necessary regulations with DEA 21 CFR 1300 to end, Bureau of Narcotics and Dangerous Drugs and state licensure, state reporting and maintaining NABP Drug Distributor Accreditation.

Catalent's Kansas City facility is home to our Oral & Specialty Drug Delivery, Biologics Analytical Services and Clinical Supply Services businesses. The site provides a range of integrated services for oral solid dosage forms, from formulation development and analytical testing to clinical and commercial-scale manufacture. The facility is the commercial manufacturing Center-of-Excellence for accelerated development programs and roller compaction.

The Kansas City facility is also a Center-of-Excellence for our Biologics Analytical Services business. Our large molecule analytical team has over 25 years of experience providing broad-based and orthogonal analytical CMC services for stand-alone and integrated biologics projects. We provide support for drug substance, drug product, and intermediates for both innovator and biosimilar / biobetter products.

Our facility also offers comprehensive clinical packaging services including clinical supply management, package engineering, clinical manufacturing, primary and secondary packaging, global distribution and logistics, and return / destruction services. The facility features an isolated potent suite and DEA Schedule I-V controlled drug storage to handle even your most challenging products.

Catalent is committed to a Patient First culture through excellence in quality and compliance, and to the safety of every patient, consumer, and Catalent employee.

The Role :

• Responsible to ensure order, receipt and process distributions are observed and recorded per site procedures to assure the inventory records of Controlled Substances are accurate and completed to meet DEA regulations
• Provide training for Authorized Associates approved to work with Controlled Substances and oversight of daily activities
• Assure new hires are appropriately screened and existing DEA Authorized Associates are rescreened, as required by site procedures while maintaining an accurate list of Authorized Associates at all times
• Support Audit Ready 365 initiatives including management of DEA inspections through ownership of DEA binder, tracking of observation findings and action completions in Trackwise, and other duties as required
• Provide support as DEA Subject Matter Expert, as required
• Responsible for the controlled substance programs at KCM to include holding Power of Attorney for DEA Registrations. Complete accurately, file, and submit (as required) DEA 222 forms, DEA imports and exports, completion of DEA renewal applications, File DEA 106s (theft and loss form), ARCOS, YERS, and required end of year reports
• Participate in all inventory variances, deviations, and / or investigations involving controlled substances
• Provide support of state licensure, including Drug Distributor Accreditation, through the review of applications; Ensure license expiration dates are monitored and renewal applications completed on time to assure KCM operates a GMP facility in compliance with Applicable Laws, including the requirements for state reporting of controlled substances
• Other duties as assigned

The Candidate :

Why You Should Join Catalent :

Catalent offers rewarding opportunities to further your career! Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the world. Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us. Join us in making a difference.

Personal initiative. Dynamic pace. Meaningful work.