DEA Lead

Position Summary:

Catalent Pharma Solutions in Kansas City, MO is hiring a DEA Lead for the Controlled Substances group. This person will ensure our Kansas City site complies with the Drug Enforcement Administration regulations 21 CFR 1300 to end, site, and Catalent Corporate requirements in support of manufacturing commercial scale and clinical trial programs. This role will handle oversight of DEA, Bureau of Narcotics and Dangerous Drugs and state licensure, state reporting, as well as maintaining NABP Drug Distributor Accreditation.

This is a full-time role position: Monday - Friday, 8:00AM-5:00PM.

Catalent is a global, high-growth, public company and a leading partner for the pharmaceutical industry in the development and manufacturing of new treatments for patients worldwide. Your talents, ideas, and passion are essential to our mission: to help people live better, healthier lives. 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.

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 lead the commercial and clinical DEA manufacturing programs at KCM to include holding Power of Attorney for DEA Registrations and DEA 222 forms and completion of DEA renewal applications
• Lead the oversight of Controlled Substance 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
• Oversight 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
• Lead Training of 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 every 2 years, as required by site procedures while maintaining an accurate list of Authorized Associates at all times
• Participate in all inventory variances, deviations, and/or investigations involving controlled substances
• Lead 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 for client audits
• Draft and update standard operating procedures and forms as required
• All other duties as assigned;

The Candidate

• Associates Degree required, Bachelor's Degree preferred
• 5 or more years of relevant DEA work experience required, with at least 3 years of experience in pharmaceutical manufacturing
• Strong indirect cross functional supervision, contractor management, and personnel skill set required
• Demonstrated knowledge of regulations and guidelines associated with cGMPs for Pharmaceutical Industry preferred
• Experience with processes and requirements for taking controlled drugs commercial
• ERP system experience preferred
• Excellent written and verbal communications skills with internal and external customers
• Good time management skills can recognize unmet needs within the team
• Advanced problem solving and decision-making skills to identify and solve work-related issues

• Individual may be required to sit, stand, walk regularly and occasionally lift 0-15 pounds;

Why you should join Catalent:

• Defined career path and annual performance review and feedback process
• Diverse, inclusive culture
• 19 days of PTO + 8 paid holidays
• Several Employee Resource Groups focusing on D&I
• Dynamic, fast-paced work environment
• Employee Stock Purchase Program
• 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
• Competitive salary
• Community engagement and green initiatives
• Generous 401K match and Paid Time Off accrual
• Medical, dental and vision benefits effective day one of employment
• Tuition Reimbursement - Let us help you finish your degree or earn a new one!
• GymPass program to promote overall physical wellness
• Perkspot - offers exclusive or private discounts from approximately 900+ merchants in a wide array of categories

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.

Catalent is committed to the health and safety of its employees, visitors and the customers and patients we serve. As a result of the global pandemic, we have modified many of our recruitment and on-boarding processes to maintain everyone's safety. The Human Resources teams will communicate all necessary safety processes and procedures throughout each stage.

personal initiative. dynamic pace. meaningful work.

Visit Catalent Careers to explore career opportunities.

Catalent is an Equal Opportunity Employer, including disability and veterans.

If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email, and confirming your request for an accommodation and include the job number, title and location to [email protected]. This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.S. Catalent employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process.

Notice to Agency and Search Firm Representatives: Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Catalent employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Catalent. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you.

Important Security Notice to U.S. Job Seekers:

Catalent NEVER asks candidates to provide any type of payment, bank details, photocopies of identification, social security number or other highly sensitive personal information during the offer process, and we NEVER do so via email or social media. If you receive any such request, DO NOT respond- it is a fraudulent request. Please forward such requests to [email protected] for us to investigate with local authorities.

California Job Seekers can find our California Job Applicant Notice HERE.