Contract Center Medical Director/Center Physician

CSL Behring - Minneapolis, MN

Full-time

Minneapolis, MN

Chemical Manufacturing

About the position

The primary physician serves as the main point of contact for reporting to the Food and Drug Administration, providing medical oversight in compliance with applicable Federal and State regulations, including Title 21 of the Code of Federal Regulations. This role involves monitoring medical compliance at the center. The physician may also serve as or delegate the duties of 'laboratory director', 'technical consultant', or 'clinical consultant' as prescribed by the Clinical Laboratory Improvement Act of 1988 regulations (CLIA). Responsibilities include ensuring that CLIA/COLA training and proficiency testing are conducted, maintaining high medical standards, and ensuring adherence to cGMPs through collaboration with center management and quality units. The physician is expected to be physically present at the center for agreed-upon hours and provide oversight to Medical Staff Associates, including their training and evaluation for certification. Regular meetings with Medical Staff Associates and center management are required to discuss medically related topics and ensure compliance with policies and procedures.

Responsibilities

• Serve as the primary physician for reporting to the FDA and provide medical oversight in compliance with regulations.
• Delegate duties of 'laboratory director', 'technical consultant', or 'clinical consultant' as per CLIA regulations.
• Ensure CLIA/COLA training and proficiency testing are conducted.
• Maintain high medical standards and ensure adherence to cGMPs.
• Provide medical oversight to Medical Staff Associates and train other physicians.
• Evaluate newly trained Medical Staff Associates for certification.
• Review and sign Medical Staff Associates notebooks weekly.
• Meet with Medical Staff Associates monthly to discuss medically related topics.
• Respond to questions regarding donor suitability for plasmapheresis.
• Conduct confidential interviews with donors and document approvals.
• Review moderate and severe medical incident reports.
• Assure health and safety of donors in immunization programs.
• Perform qualifying evaluations for red cell recipients in the Anti-D Program.
• Determine donor suitability following adverse reactions.
• Perform Center Physician functions as needed.
• Perform additional services as requested by the company.

Requirements

• MD or DO degree from an accredited medical or osteopathic school.
• Current and active medical license in the state of the Center.
• One year of residency training as an MD or OD.
• Familiarity with Code of Federal Regulations (CFR) and Plasma Operating Procedures.

Benefits

• Encouragement to prioritize well-being.
• Diversity and inclusion initiatives.