Technical Operations Manager, GMP Engineering and Cell Manufacturing Facility

Location: Cancer Cell Center (CCC)

Title

Job Type

Regular

Company

Health Research, Inc. (HRI) Roswell Park Division

Department

Center for Immunotherapy

Time Type

Full time

Weekly Hours

40

FTE

1

Shift

First Shift (United States of America)

Summary

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.

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

Qualifications

Required Education and Experience

• PhD in a health, life science, engineering, or related field and the equivalent of five (5) years of full-time experience in GMP cell therapy, viral vector, gene therapy, biologics, or related advanced therapy manufacturing, process development, analytical development, quality control, or MSAT, including the equivalent of eighteen (18) months of experience in a supervisory, consultative, managerial, or executive capacity; or
• Master's degree in a health, life science, engineering, or related field and the equivalent of seven (7) years of full-time experience in GMP cell therapy, viral vector, gene therapy, biologics, or related advanced therapy manufacturing, process development, analytical development, quality control, or MSAT, including the equivalent of eighteen (18) months of experience in a supervisory, consultative, managerial, or executive capacity; or
• Bachelor's degree in a health, life science, engineering, or related field and the equivalent of nine (9) years of full-time experience in GMP cell therapy, viral vector, gene therapy, biologics, or related advanced therapy manufacturing, process development, analytical development, quality control, or MSAT, including the equivalent of eighteen (18) months of experience in a supervisory, consultative, managerial, or executive capacity.

NOTE

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

The preferred candidate will have

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