Operations Director, cGMP & Tissue Biologic Manufacturing

Scorpion Therapeutics; Vandalia (OH); On-site; USD 110,000 - 150,000; Full time

Job summary

Axogen is seeking an Operations Manager to lead the newly established Cleaning & Sanitation department. The role emphasizes managing daily operations, staffing, training, safety, and quality assurance in a regulated biotech setting.

You will ensure compliance with cGMP and FDA requirements, drive continuous improvement, and partner with Quality, R&D, and other functions to strengthen processes, with an emphasis on results and cross-functional collaboration.

Qualifications

• Minimum 5 years in operations or QA within medical device, pharmaceutical, or biotech manufacturing.
• 3+ years of leadership or project management.
• Bachelor's in Life Science or Engineering.
• Strong knowledge of cGMP, FDA, and regulated environments.
• Leadership, communication, and problem-solving skills.

Responsibilities

• Oversee daily operations and staffing in Cleaning & Sanitation department.
• Ensure compliance with cGMP and FDA regulations.
• Drive continuous improvement initiatives.
• Collaborate with Quality, R&D, and other departments.
• Staffing, training, safety, quality assurance, process development.

Skills

Leadership

Communication

Problem solving

Regulatory knowledge

Project management

Education

Bachelor's in Life Science or Engineering

Tools

Lean

Six Sigma

DMAIC

cGMP compliance

Job description

Axogen is seeking an Operations Manager to lead the newly established Cleaning & Sanitation department. The role emphasizes managing daily operations, staffing, training, safety, and quality assurance in a regulated biotech setting.

You will ensure compliance with cGMP and FDA requirements, drive continuous improvement, and partner with Quality, R&D, and other functions to strengthen processes, with an emphasis on results and cross-functional collaboration.