Catalent
Manager, Drug Enforcement Administration
Catalent, Kansas City, Missouri, United States, 64101
Manager, Drug Enforcement Administration
Position Summary
Catalent, Inc. is a leading global contract development and manufacturing organization (CDMO) dedicated to delivering unparalleled service to pharma, biotech, and consumer health customers. The
Manager, Drug Enforcement Administration
position is full‑time and salaried, based out of our Kansas City, MO site. The holder will oversee DEA regulatory compliance of controlled substances across pharmaceutical dosage forms in development, laboratory, manufacturing, and packaging environments, ensuring adherence to 21 CFR 1300, state licensure, state reporting, and NABP Drug Distributor Accreditation.
Responsibilities
Ensure order, receipt and process distributions are observed and recorded per site procedures, maintaining accurate inventory records of controlled substances and meeting DEA regulations.
Provide training for Authorized Associates approved to work with controlled substances and oversee their daily activities.
Screen new hires and rescreen existing DEA Authorized Associates, 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 a DEA Subject Matter Expert, as required.
Manage the controlled substance programs at KCM, including holding Power of Attorney for DEA Registrations, filing and submitting DEA 222 forms, managing import/export, completing renewal applications, filing 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.
Support state licensure, including Drug Distributor Accreditation, by reviewing applications and ensuring timely renewal, maintaining GMP compliance and state reporting of controlled substances.
Perform other duties as assigned.
Candidate Requirements
Bachelor’s degree, required.
Minimum five years of DEA compliance experience, required.
Demonstrated people‑management experience with at least three direct reports, required.
Scientific and quality assurance experience, preferred.
Ability to sit, stand, walk regularly and occasionally lift 0‑15 pounds.
Demonstrable internal leadership experience at Catalent (e.g., participation in NGGL, GOLD, LEAD Now, GM Excellence, GROW) may be considered in place of external experience.
Benefits
Defined career path with annual performance review and feedback.
Diverse, inclusive culture.
152 hours of PTO plus 8 paid holidays.
Multiple employee resource groups focused on D&I.
Dynamic, fast‑paced work environment.
Positive working environment focused on continually improving processes and innovation.
Career growth opportunities within an expanding team.
Community engagement and green initiatives.
Generous 401(k) match.
Medical, dental and vision benefits effective day one.
Tuition reimbursement.
WellHub program for overall physical wellness.
PerkSpot—exclusive discounts from over 900 merchants.
Catalent offers rewarding opportunities to further your career. We help bring over 7,000 life‑saving and life‑enhancing products to patients worldwide, producing more than 70 billion doses per year.
If you require reasonable accommodation for any part of the application or hiring process due to a disability, submit your request via email to DisabilityAccommodations@catalent.com, including the job number, title, and location.
Catalent is an Equal Opportunity Employer, including disability and veterans.
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Manager, Drug Enforcement Administration
position is full‑time and salaried, based out of our Kansas City, MO site. The holder will oversee DEA regulatory compliance of controlled substances across pharmaceutical dosage forms in development, laboratory, manufacturing, and packaging environments, ensuring adherence to 21 CFR 1300, state licensure, state reporting, and NABP Drug Distributor Accreditation.
Responsibilities
Ensure order, receipt and process distributions are observed and recorded per site procedures, maintaining accurate inventory records of controlled substances and meeting DEA regulations.
Provide training for Authorized Associates approved to work with controlled substances and oversee their daily activities.
Screen new hires and rescreen existing DEA Authorized Associates, 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 a DEA Subject Matter Expert, as required.
Manage the controlled substance programs at KCM, including holding Power of Attorney for DEA Registrations, filing and submitting DEA 222 forms, managing import/export, completing renewal applications, filing 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.
Support state licensure, including Drug Distributor Accreditation, by reviewing applications and ensuring timely renewal, maintaining GMP compliance and state reporting of controlled substances.
Perform other duties as assigned.
Candidate Requirements
Bachelor’s degree, required.
Minimum five years of DEA compliance experience, required.
Demonstrated people‑management experience with at least three direct reports, required.
Scientific and quality assurance experience, preferred.
Ability to sit, stand, walk regularly and occasionally lift 0‑15 pounds.
Demonstrable internal leadership experience at Catalent (e.g., participation in NGGL, GOLD, LEAD Now, GM Excellence, GROW) may be considered in place of external experience.
Benefits
Defined career path with annual performance review and feedback.
Diverse, inclusive culture.
152 hours of PTO plus 8 paid holidays.
Multiple employee resource groups focused on D&I.
Dynamic, fast‑paced work environment.
Positive working environment focused on continually improving processes and innovation.
Career growth opportunities within an expanding team.
Community engagement and green initiatives.
Generous 401(k) match.
Medical, dental and vision benefits effective day one.
Tuition reimbursement.
WellHub program for overall physical wellness.
PerkSpot—exclusive discounts from over 900 merchants.
Catalent offers rewarding opportunities to further your career. We help bring over 7,000 life‑saving and life‑enhancing products to patients worldwide, producing more than 70 billion doses per year.
If you require reasonable accommodation for any part of the application or hiring process due to a disability, submit your request via email to DisabilityAccommodations@catalent.com, including the job number, title, and location.
Catalent is an Equal Opportunity Employer, including disability and veterans.
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