Manager, Operations & Continuous Improvement; GMP Cell & Gene Therapy

Position: Manager, Operations & Continuous Improvement (GMP Cell & Gene Therapy)
Manager, Operations & Continuous Improvement (GMP Cell & Gene Therapy) page is loaded## Manager, Operations & Continuous Improvement (GMP Cell & Gene Therapy) locations:
Cancer Cell Center (CCC) time type:
Full time posted on:
Posted Todayjob requisition :
R-20172##
*
* Title:

** Manager, Operations & Continuous Improvement (GMP Cell & Gene Therapy)
** 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:

** Be the systems builder for a growing, multi-product cell manufacturing operation. You’ll stand up practical day-to-day operations tools (tiered huddles, standard work, visual flow, simple KPIs), drive problem solving with Manufacturing/MSAT, and help us on-ramp new cell products smoothly. Prior cell therapy is not required, but you must bring excellent GMP discipline, an OE toolkit, and the ability to learn fast on the floor.
Key Aspects:  
• Launch and sustain tiered daily management (cell mfg) with clear KPIs, short action logs, and escalations.  
• Build and maintain standard work/SOP job aids (operator checklists, change-over, handoff sheets).  
• Run basic capacity/slotting and staffing models (Excel/Sheets) for autologous flow and small-batch processes.  
• Facilitate root cause / A3 problem solving and partner with QA on deviations/CAPAs (close on time, prove effectiveness).  
• Lead 5S/visual management in staging, prep, and cleanroom-adjacent areas (GMP-appropriate).  
• Coordinate readiness for new products/changes with MSAT (PFMEA inputs, training rollout, room readiness).  
• Help IT/QA translate needs into LIMs workflows (labels, COI/COC, simple dashboards).
Salary range for this position is $80,000 - $90,000 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.

Preferred Qualifications:

* 3–7 years in GMP or regulated ops (biologics, pharma, med device, sterile compounding, diagnostics, food, or high-mix manufacturing
* Hands-on continuous improvement (5S, standard work, VSM, A3, 8D, basic SPC) with measurable results
* Strong Excel/Sheets; able to build practical trackers and visual boards
* Clear communicator; calm under time pressure; “go see” (gemba) mindset
* Exposure to aseptic operations or clean rooms
* Experience with MES/LIMS/eQMS (any system)
* Lean/Six Sigma Green Belt (or equivalent experience)
* Any experience with cell culture/biologics (academic or industry)
** 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-Pay And Benefits  …