Manager, Operations & Continuous Improvement (GMP Cell & Gene Therapy) at Roswell Park Comprehensive Cancer Center

, , United States -

Full Time

Start Date

Immediate

Expiry Date

13 Feb, 26

Salary

90000.0

Posted On

15 Nov, 25

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

GMP Discipline, Continuous Improvement, Excel, Visual Management, Root Cause Analysis, Problem Solving, Standard Work, Aseptic Operations, Cell Culture, Lean Six Sigma, Capacity Modeling, Training Rollout, Collaboration, Communication, Quality Assurance, Manufacturing

Industry

Hospitals and Health Care

Description

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 cleanrooms 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-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. Welcome to Roswell Park Comprehensive Cancer Center, America's first cancer center founded in 1898 by Dr. Roswell Park. As one of the largest employers in Western New York, Roswell has over 3,300 employees, including over 200 physicians and scientists and 400 nurses. It’s a new era at Roswell Park. Leading the way in cancer research, treatment and education for more than a century, today Roswell Park is setting our course for a second century of extraordinary advances in cancer research and treatment. Equipped with the best facilities, the sharpest and most creative minds, and the single objective of curing cancer, we stand on the threshold of historic discovery.

Responsibilities

The Manager will build and sustain daily management systems for cell manufacturing operations, focusing on KPIs and problem-solving. They will also coordinate readiness for new products and facilitate collaboration with QA and MSAT teams.