Sr. DEA Supervisor

SR Supervisor/Supervisor, DEA 

Tris Pharma, Inc. (www.trispharma.com) is a leading privately-owned biopharmaceutical company in the U.S. with a focus on development and commercialization of innovative medicines that address unmet patient needs. We have more than 150 US and International patents including applications and have marketed several branded and generic products in the U.S., have licensed our products in the US and international markets, and have a robust pipeline of innovative products spanning neuroscience and other therapeutic categories employing our proprietary science and technology.

Our science and technology make us unique, but it is our team members that set us apart; they are the engine that fuels Tris’ passion and innovation. Tris colleagues understand the criticality of operating a successful business and take pride in the company’s success. But of equal importance to each member of the team is how we interact with one another on a daily basis. We believe in each other and we believe in respectful, open and honest communications to help support individual and team success. 

Our DEA department located in our Monmouth Junction, NJ headquarters has an immediate need for an experienced SR Supervisor or Supervisor, DEA. 

The (Sr) DEA Supervisor oversees and coordinates all day-to-day aspects of drug enforcement administration (DEA) activities and reporting for new and existing controlled substances and products. The incumbent has full cycle operational oversight for tracking and monitoring all DEA registration requirements including but not limited to: receipt, handling, storage, waste, quota, DEA Form 222, distribution of controlled substance material, etc. in order to meet requirements including deadlines and quality in accordance to DEA, Standard Operating Procedures (SOPs), current Good Manufacturing Practices (cGMPs). 

• Prepares and submits DEA and state reports, including but not limited to Automated Reports and Consolidated Order System (ARCOS), Year End Reports (YERS), etc. for all company DEA registrations 

• Performs and tracks quota (procurement and usage) in real-time, prepares and signs DEA Form 222, and quota letters, as needed

• Monitors waste/reject material for destruction schedule shipment for destruction; Follow-ups with user group for pending waste paperwork as require 

• Performs and tracks DEA daily activities, including but not limited to: inventories in real-time (good materials, waste, samples), controlled substance storage access, batch reconciliation, process loss, shipping, receiving, controlled substance store access, store/remove materials, JDEdwards transactions, and material movements daily or as needed

• Reviews and revises Standard Operating Procedures (SOPs) and current Good Manufacturing Practices (cGMPs) documents, as required 

• Resolves daily activities issues (if any), maintains system and leads continuous process improvement, as required

• Provides support to DEA team to ensure all DEA requirements are completed in a timely and accurate manner, including quota submissions, SOMS, import, export, DEA & state reports, audits, inspections, etc.

· Supervises day-to-day DEA activities and assists DEA manger with safety, scheduling, staffing, material management, compliance, training and auditing/inspection activities for a small DEA team; Supports compliance with DEA regulations and company policy and procedure

Special knowledge or skills needed and/or licenses or certificates REQUIRED

Bachelor degree AND minimum 3 years hands-on experience working with controlled substances activities, including DEA reports, in the pharmaceutical or biotechnology industry OR combination of education and above hands-on DEA related experience in the pharmaceutical or biotechnology industry REQUIRED

• Working knowledge of good manufacturing systems and familiarity with regulatory and manufacturing SOPs, batch records and cGMPs REQUIRED

• Current, hands on experience working directly with the DEA and/or handling DEA related activities including, but not limited to: inventory control and accountability measures for controlled substances, maintenance of proper security and chain of custody records, regulation of proper waste disposal, etc. REQUIRED

• Demonstrated ability to read and interpret documents such as safety and environmental policies and procedure manuals, etc. REQUIRED

· Supervisory or Team Lead experience PLUS

Physical Requirements

Office/Manufacturing/Lab based position

Ability to lift up to 50 lbs, as needed 

Ability to use Personal Protective Equipment (PPE), as needed 

Ability to stand for extended periods, as needed 

Tris Pharma, Inc. offers a highly competitive compensation and benefits package. To build and enhance our diverse workforce, we encourage applications from individuals with disabilities, minorities, veterans, women, LGBTQ, etc. Tris Pharma, Inc. is an Equal Opportunity Employer. #LI-DNI