Description
Title: GMP Manufacturing Operations Manager
Job Type:
Regular Company: Health Research, Inc. (HRI) Roswell Park Division Department: Center for Immunotherapy Time Type: Full time Weekly Hours: 40FTE:
1 Shift: First Shift (United States of America) Summary: The GMP Engineering & Cell Manufacturing Facility is seeking a hands-on Manufacturing Operations leader to run and scale GMP execution across advanced therapy programs (cell therapy and/or vector/plasmid operations, depending on assignment). This role owns daily operations, builds durable operating systems, and drives continuous improvement to increase throughput, compliance, and right-first-time performance.We're looking for someone who can combine floor leadership with process and systems-building standard work, tiered management, KPI operating cadence, and practical digitalization (ERP/LIMS/MES/eQMS).
What you'll do
GMP execution & team leadership
•Lead day-to-day GMP manufacturing operations: campaign readiness, staffing, shift/hand-off routines, materials readiness, and schedule attainment.
•Coach a high-accountability culture focused on safety, compliance, and operational excellence.
Process development (operational) & continuous improvement
•Build/refresh operational processes: production readiness checklists, gowning/flow discipline, logbooks, batch record execution routines, and “run the business” meetings.
•Drive Lean/Six Sigma projects to improve RFT, deviations rate, cycle time, and on-time batch release-using root cause analysis and CAPA effectiveness checks.
Systems & scaling (the “ops backbone”)
•Develop scalable systems for Tech Ops: capacity planning, training qualification tracking, deviation trending, and KPI dashboards.
•Partner on digital/process-system implementations across ERP/LIMS/eQMS/MES; drive adoption on the floor.
Cross-functional delivery & tech transfer
•Coordinate with MSAT, QA, QC, Engineering, and Supply Chain to deliver programs on time and within quality standards.
•Support tech transfer into GMP execution, including risk identification, readiness, and smooth campaign start-up
Quality & inspection readiness
•Ensure inspection-ready documentation and GDP practices; support deviations/investigations, change controls, batch record review, and audit responses.
What you'll bring
•BS/MS in life sciences, engineering, pharmacy, or related field (or equivalent experience).
•Manager: 7+ years in GMP manufacturing operations (biologics/ATMP preferred)
Sr. Manager: 10-14+ years with multi-team leadership and/or multi-area ownership
•Proven experience leading investigations/CAPAs, change control, and shop-floor execution in regulated environments.
•Demonstrated ability to build operational processes and management systems (KPIs, meeting cadences, standard work).
The salary range for this position is $90,000 - $110,000 which includes a comprehensive benefits package. The listed pay range reflects the range of potential compensation for this role. The actual offer may vary based on qualifications, skills, and experience. Qualifications: Required Education and Experience
1. M.D. or PhD in an appropriate field; or
2. Master's degree in an appropriate field.
NOTE:
Required degrees must have been granted by an accredited school, college or university or one recognized by Roswell Park Comprehensive Cancer Center as following acceptable educational practices.
- Lean Six Sigma Black Belt (or equivalent demonstrated CI leadership).
- Certified Scrum Master / Agile delivery experience (helpful for systems implementations and cross-functional execution).
- 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.
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-PayAndBenefits@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.
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