GMP Manufacturing Operations Manager

Roswell Park Comprehensive Cancer Center

10h • $90,000 - $110,000

About The Position

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).

Requirements

• 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).
• M.D. or PhD in an appropriate field; or
• 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.

Nice To Haves

• 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).

Responsibilities

• 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.
• 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.
• 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.
• 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
• Ensure inspection-ready documentation and GDP practices; support deviations/investigations, change controls, batch record review, and audit responses.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager