Technical Operations Manager, GMP Engineering and Cell Manufacturing Facility

Title

Technical Operations Manager, GMP Engineering and Cell Manufacturing Facility 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

1. 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
2. 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
3. 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)
• L ean Six Sigma Black Belt (or equivalent demonstrated CI leadership)
• CDMO experience, including client-facing delivery, tech transfer, and rapid timeline execution
• E xperience with common quality/systems tools (e.g., TrackWise / MasterControl / similar)

Equal Employment Opportunity Statement

Roswell Park Cancer Institute Corporation (RPCIC) and Health Research Inc. (HRI) Roswell Park Division believe that all persons are entitled to equal employment opportunities, and we do not discriminate against our employees, applicants or job seekers because of their race, color, religion, sex, sexual orientation, gender identity or expression, national origin, creed, age, disability, pregnancy-related condition, military or veteran status, marital or familial status, domestic violence victim status, citizenship status, genetic information, individual’s relationship or association with a member of a protected category or any other protected group status as defined by law.

Affirmative Action/Equal Opportunity Employer/Qualified Individuals with Disabilities/Qualified Protected Veterans

Reasonable Accommodation Request

RPCIC and HRI are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the employment process, please email HR-BenefitsandLeaves@roswellpark.org and let us know the nature of your request and your contact information.

Our Core Values

RPCIC and HRI are committed to providing an environment where patients, families, employees and community are treated with courtesy and respect. We support an inclusive environment that nurtures the talents, skills and abilities of each individual to embody and reflect our core values: Innovation, Integrity, Teamwork, Commitment, Compassion and Respect.

Grant Funding

This is a grant-funded position. Compliance with funding requirements such as time and effort reporting, grant deliverables, and contract deliverables is required.

E-Verify Employer

Health Research Inc. (HRI) Roswell Park Division participates in the E-Verify program.