Technical Operations Manager, GMP Engineering and Cell Manufacturing Facility

roswellpark; United States; On-site; USD 111,000 - 136,000; Full time

Job summary

Health Research, Inc. (HRI) Roswell Park Division seeks a Technical Operations Manager to lead the GMP Engineering & Cell Manufacturing Facility for CAR-T and other cell therapies.

You will supervise a team of professionals, coordinate manufacturing, process development, and analytics activities, and ensure adherence to cGMP and safety standards. You will partner with multiple departments to optimize production, implement improvements, and manage resources, budgets, and schedules to meet client

Qualifications

• PhD or Master’s with GMP Manufacturing experience required.
• Degrees must be conferred by an accredited institution or recognized equivalent.
• Experience in GMP manufacturing environments is essential.

Responsibilities

• Oversee day-to-day operations of GMP cell manufacturing and facilities.
• Lead manufacturing and analytics development activities with cross-functional teams.
• Ensure compliance with cGMP, safety protocols, and regulatory standards.
• Participate in budgets, statements of work, and reporting for internal/external customers.

Skills

Certified Scrum Master

Lean Six Sigma Black Belt

CDMO experience

Quality systems experience

Education

PhD in health or science field + 3 years GMP Manufacturing experience

Master's degree in health or science field + 5 years GMP Manufacturing experience

Tools

TrackWise

MasterControl

Job description

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

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 or science related field and the equivalent of three (3) years of full-time experience in GMP Manufacturing; or
• 2. Master's degree in a health or science related field and the equivalent of five (5) years of full-time experience in GMP Manufacturing.

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)

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.

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 [e-mail] 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.