Controlled Substance - Scientific/Pharmaceutical Program Manager
Do you have a background managing a Controlled Substances pharmaceutical or similar program, and expertise working with the DEA and regulatory guidelines? Are you looking to move your career forward and grow with a leading Biotech company? This could be the role you are looking for!
Join a team that consists of innovative professionals with diverse skillsets who work together to achieve the goal of safely manufacturing high-quality small molecules that are used in numerous Life Science products to improve lives around the globe.
WHAT YOU'LL DO:
The Controlled Substance Scientific Program Manager is responsible for the implementation of an emerging Controlled Substance program to ensure compliant manufacturing and distribution of clinically relevant psychedelic medicines. This role will provide subject matter guidance in the development of processes and procedures to uphold regulatory requirements and best practices. DEA regulated business activities include research, development, analysis, and API and drug product manufacturing at multiple registered locations including a correlated non-profit Institute.
Monitor the performance of the controlled substance program to understand and mitigate compliance risk. Communicates with cross-functional stakeholders and proposes improvements to the program.
Work in close partnership with site leadership, QA/RA, Logistics, Manufacturing, and lab staff, providing technical guidance and support with activities involving with controlled substances.
Write and maintain procedures and forms related to controlled substances.
Develop and deliver training to employees.
Manage registration applications and renewals for all Federal DEA Registrations and State licensures.
Ensure security and access procedures and policies are adequate and maintained.
Coordinate and manage processes and documentation required for movement and transfers of controlled substances throughout manufacturing and operations.
Manage inventory reconciliation processes for all controlled substances at the registered sites. Responsible for investigating all inventory discrepancies of controlled substances. Leads investigations into the loss or theft of controlled substances.
Review manufacturing batch records and other cGMP documentation related to controlled substances as required.
Complete quarterly ARCOS, biennial, and year-end inventory reports for controlled substances as required by the DEA.
Develop and maintain all documents required for DEA quota applications, approvals, tracking, and amendments.
Execute, file, track, and audit DEA Form 222 order forms for both procurement and supply activities.
In coordination with logistics, complete DEA import and export permit applications via the DEA IMEX portal.
Conduct internal audits, following up on findings and corrective actions.
Lead external DEA inspections, interfacing with governmental agencies such as federal and state DEA representatives.
Coordinate the destruction activities for all controlled substances with lab staff, QA, EH&S, and Logistics and approve destruction methods in accordance with DEA requirements.
Maintain proper record keeping.
Demonstrate inclusion through words and actions and be accountable for a safe workspace. Act with kindness, curiosity and respect for others.
Understand and comply with ethical, legal and regulatory requirements applicable to the business.
WHAT YOU'LL BRING:
Minimum High School diploma; BS in science or similar degree preferred.
5-8 years direct DEA compliance experience or pharmaceutical experience that includes working directly with controlled substances.
Keen awareness and technical knowledge of DEA regulations and how they are applied in a pharmaceutical manufacturing environment.
Ability to build relationships by communicating effectively and thoughtfully, using diplomacy and tact.
High degree of initiative with demonstrated ability to work independently and meet timelines. Ability to be calm when situations are stressful or ambiguous.
Able to adapt to changes in priorities based upon shifting business needs.
Ability to utilize tools and technologies to create seamless business interactions, connections, and transparency.
Familiar with working in a cGMP environment and compliance with FDA regulations.
Proficiency in inventory management and other controlled substance compliance systems (SAP, CSOS, etc.).
If you're looking for a great opportunity and growth in your career apply now! Questions? Contact Andie Veach at firstname.lastname@example.org
About Us At Carex, We Are Career Matchmakers. Your ideal career is out there. Carex curates the best opportunities for top candidates and makes it easier for both job seekers and employers to find their ideal fit. Carex Scientific, a division of Carex Consulting Group, works exclusively with scientists throughout the U.S. and across a spectrum of backgrounds and industries. We are Scientists placing Scientists and focus on building long-term partnerships and helping candidates find their ideal next step. At Carex, Candidates are people and fellow professionals, not metrics.
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