Technical Operations Manager, GMP Engineering and Cell Manufacturing Facility

Leads a team of professional associates responsible for the manufacturing of CAR-T and other cell therapies within the GMP Engineering & Cell Manufacturing Facility. Oversees the day-to-day operations of cell therapy programs, including manufacturing and facilities cleaning and maintenance. Coordinates process and analytical development activities, ensuring compliance with cGMP (Good Manufacturing Practice) regulatory standards and safety protocols as well as managing the company’s resources effectively. Ensures efficient production processes and effective analytical strategies and methods, coordinating with different departments, and implementing innovative approaches to improve productivity and profitability. Works closely with the team to provide process, material, and equipment knowledge to meet customer requirements and addresses operational and routine challenges as they arise for manufacturing. Participates and assists Technical Operations management with the preparation of budgets, statements of work, and other documents requested by internal and external customers required for reporting purposes, oversight of operations, and for publication.

Responsibilities

• Oversee day-to-day operations of cell therapy manufacturing, including facilities cleaning and maintenance.
• Coordinate process and analytical development activities to ensure compliance with cGMP regulatory standards and safety protocols.
• Manage resources effectively to ensure efficient production processes and analytical strategies.
• Implement innovative approaches to improve productivity and profitability.
• Provide process, material, and equipment knowledge to meet customer requirements.
• Address operational and routine challenges in manufacturing.
• Assist in preparing budgets, statements of work, and other required documents for reporting and oversight.
• Ensure compliance with grant funding requirements, including time and effort reporting, grant deliverables, and contract deliverables.

Requirements

• PhD in a health or science related field and three (3) years of full-time experience in GMP Manufacturing; or
• Master’s degree in a health or science related field and five (5) years of full-time experience in GMP Manufacturing.
• Degrees must be conferred by an accredited school, college, or university, or by an institution recognized by Roswell Park Comprehensive Cancer Center and/or Health Research Incorporated as adhering to acceptable educational standards.

Preferred Qualifications

• Certified Scrum Master / Agile delivery experience (helpful for systems implementations and cross-functional execution).
• Lean Six Sigma Black Belt (or equivalent demonstrated continuous improvement leadership).
• CDMO experience, including client-facing delivery, tech transfer, and rapid timeline execution.
• Experience with common quality/systems tools (e.g., TrackWise / MasterControl / similar).

Pay

The salary range for this position is $111,387 - $135,829 annually. The actual offer may vary based on qualifications, skills, and experience.

Benefits

This position includes a comprehensive benefits package.

Schedule

• Full time
• 40 hours per week
• First shift