Manager, Drug Enforcement Administration

Catalent•Kansas City, MO

5d•Onsite

About The Position

Manager, Drug Enforcement Administration Position Summary: This is a full-time salaried position, based out of our Kansas City, MO site. The Manager, Drug Enforcement Administration will o versee 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 s upport 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.

Requirements

Bachelor’s Degree, required
Minimum of five years of DEA Compliance experience, required
Demonstrated people management over at least 3 direct reports, required
Individual may be required to sit, stand, walk regularly and occasionally lift 0-15 pounds

Nice To Haves

Scientific and Quality Assurance experience, preferred
Demonstrable leadership experience at Catalent (including but not limited to participation in Catalent-sponsored leadership programs such as NGGL, GOLD, LEAD Now, GM Excellence, and GROW) may be considered in place of external experience

Responsibilities

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

Benefits

Defined career path and annual performance review and feedback process
Diverse, inclusive culture
152 hours of PTO + 8 paid holidays
Several Employee Resource Groups focusing on D&I
Dynamic, fast-paced work environment
Positive working environment focusing on continually improving processes to remain innovative
Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives
Community engagement and green initiatives
Generous 401K match
Medical, dental and vision benefits effective day one of employment
Tuition Reimbursement
WellHub - program to promote overall physical wellness
Perkspot - offers exclusive or private discounts from approximately 900+ merchants in a wide array of categories