We are GROWING! Manager, Operations (Cleaning & Sterilization)

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

Role

Operations Manager overseeing the newly established Cleaning & Sanitation department at Axogen, with primary responsibilities in managing daily operations, ensuring compliance with cGMP and FDA regulations, and driving continuous improvement initiatives. Responsibilities include staffing, training, safety, quality assurance, process development, and cross-functional collaboration with Quality, R&D, and other departments.

Requirements

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.

Preferred

experience with biologics, tissue processing, or sterile manufacturing, and familiarity with lean, Six Sigma, or DMAIC methodologies.

High-value

leading tissue biologic production, cGMP compliance, regulatory support (FDA, ISO, AATB), and managing operational metrics related to safety, quality, and productivity.

Work setup

based in Vandalia, OH, with at least 10% travel required.