Summary

The Center for Coregulator Research is recruiting a Supervisor, Research Operations to oversee and have hand on the unit's daily activities, ensuring alignment with business goals. Reporting directly to Dr. David Lonard, the role includes managing quality assurance and safety programs, handling regulatory submissions, and ensuring a safe environment by monitoring risks and adhering to standards. The Supervisor will meticulously plan and monitor research project expenditures while managing the inventory of lab equipment and supplies. This role involves preparing work plans and schedules, monitoring project progress, and regularly reporting updates to management. Additionally, the Supervisor will develop process improvements, oversee special projects, and conduct special scientific project and train staff.

Job Duties

• Research Operations Management
  • Daily Oversight: Monitor and guide the research team to ensure projects are on track, addressing any issues promptly.
  • Project Planning: Develop detailed work plans and timelines for upcoming research projects, ensuring resources are appropriately allocated. Additionally, the position entails pre-IND enabling research and development activities related to small molecule compound development.
  • Provide technical supervision; plans and supports employees in career development opportunities.
  • Resource Management: Regularly check inventory levels of lab equipment and supplies, placing orders as necessary to avoid disruptions.
• Quality Assurance and Safety
  • Program Coordination: Conduct weekly meetings to review and update quality assurance protocols and safety procedures.
  • Compliance Checks: Perform routine inspections and audits to ensure adherence to safety regulations and quality standards.
  • Incident Management: Address and document any safety incidents or quality issues, implementing corrective actions and preventive measures.
• Process Improvement
  • Review Sessions: Hold bi-weekly sessions to review current processes, identifying areas for improvement and brainstorming solutions.
  • Implementation: Develop and implement new procedures or modify existing ones to increase efficiency and productivity.
  • Training: Provide ongoing training to staff on new processes and tools to ensure seamless adoption.
• Regulatory Activities
  • Document Preparation and Compliance: Oversee the preparation and submission of regulatory documents, ensuring accuracy and compliance with regulatory requirements.
  • Engage in translational research aimed at gaining FDA approval for cell-based therapies.
  • Follow-ups: Maintain regular communication with regulatory bodies, addressing any feedback or requests for additional information.

Minimum Qualifications

• High School diploma or GED.
• Four years of relevant experience.

Preferred Qualifications

• Bachelor’s degree. No experience required with Bachelor’s degree.
• Research Technician experience
• Lab Manager experience
• Scientific knowledge of the following: Immune Cell isolation and Culturing, Tcell Adoptive Cell Transfer
• Experience in cell-based therapies and in drug development efforts
• Academic and/or company experience in bringing therapeutic agents into clinical trials