This position will provide support in maintaining the company’s compliance with DEA regulations, controlled substance handling and Environmental, Health and Safety regulations at the Waltham facility. Reporting to the Associate Director of EHS, this position will include the following duties and responsibilities:
• Ensure compliance with all State and Federal Controlled Substance Regulations.
• Develop and maintain compliance programs (policies, procedures, etc.).
• Train personnel who work with controlled substances.
• Submit and track reports required by the DEA and Massachusetts DPH.
• Procure and maintain required DEA and Massachusetts DPH registrations.
• Procure required quotas.
• Conduct required inventories of controlled substances.
• Oversee destruction activities of controlled substances.
• Conduct internal controlled substance audits to ensure compliance.
• Monitor changes in regulations to ensure policies and procedures are current.
• Direct communication with DEA/Mass DPH.
• Perform and/or assist in the performance of hazard assessments.
• Develop and maintain EHS programs and procedures.
• Conduct periodic EHS inspections to assess compliance with regulatory and Alkermes requirements.
• Recommend corrective actions where appropriate and follow-up to verify completion.
• Provide training programs in technical areas as required.
• Perform industrial hygiene sampling for various potential hazards including noise, organic solvents, and/or active pharmaceutical ingredients.
• Monitor compliance of chemical use.
• Monitor environmental compliance.
• Prepare environmental-related regulatory reports and compile any necessary data to support them.
• Coordinate EHS-related emergency response preparation efforts.
Internal Communication: Works with Pharmaceutical R&D, Process Development, Facilities, and Purchasing to ensure compliance with all DEA regulatory requirements.
External Communication: Regularly communicates with DEA on status of registrations, schedule changes, quota applications, etc.
Minimum Education & Experience Requirements: Bachelor degree in science or health-related field and five (5) years experience primarily in DEA compliance for the pharmaceutical or biotech industry. Additional experience in Environmental Health and Safety compliance is also desirable. Candidates without pharmaceutical or biotech experience may be considered if demonstrating exceptional qualifications.
Knowledge/Skills Needed: The candidate must be well versed in regulations pertaining to controlled substances and be knowledgeable of DEA regulations and ideally Mass DPH regulations as they apply to controlled substances. Knowledge of occupational health/safety and environmental issues is also desired. This individual must be able to communicate efficiently and effectively in both oral and written presentations. Additionally, the candidate must be competent with Microsoft Word and sufficiently skilled with computers to easily navigate through the Microsoft Windows platform, Microsoft Outlook and Excel. The successful candidate will be expected to work on complex problems in which analysis of situations or data requires an in-depth evaluation of various factors. He/she will be expected to exercise judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results. The individual may determine methods and procedures on new assignments and may provide guidance to contractors, vendors and all levels of the Alkermes organization. The candidate should be capable of leading problem-solving exercises.
Personal Attributes Needed: The individual must demonstrate values consistent with those important to Alkermes: integrity, excellence, respect, teamwork, and accountability. He/she must also demonstrate a high degree of reliability and self-discipline. Flexibility in problem-solving will be important. Equally important will be the need for rational fact-based decision making.
A reasonable amount of on-site mobility will be required. Office desk work is also required of this position.
substance abuse testing.
Alkermes, Inc. is an equal employment opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, disability, genetic information, veteran status, military status, application for military service or any other class protected by state or federal law.