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About the Role

Leads a team responsible for the manufacturing of CAR-T and other cell therapies within the GMP Engineering & Cell Manufacturing Facility. Oversees daily operations, including manufacturing, facilities cleaning, and maintenance. Coordinates process and analytical development, ensuring cGMP compliance and safety. Manages company resources effectively, implements innovative approaches to improve productivity, and provides process, material, and equipment knowledge to meet customer requirements.

Responsibilities

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 regulatory standards and safety protocols.
Manages the company’s resources effectively.
Ensures efficient production processes and effective analytical strategies and methods.
Coordinates 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.
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 for reporting purposes, oversight of operations and for publication.
Compliance with funding requirements such as time and effort reporting, grant deliverables, and contract deliverables is required.

Requirements

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

Skills

GMP Manufacturing
Process development
Analytical development
cGMP compliance
Safety protocols
Resource management
Production processes
Analytical strategies
Customer requirements
Operational challenges
Budget preparation
Statements of work
Scrum Master / Agile delivery
Lean Six Sigma Black Belt
CDMO experience
Tech transfer
Rapid timeline execution
Quality/systems tools

Location

First Shift (United States of America)

Work Type

Full time
Regular

Experience Level

3 years of full-time experience in GMP Manufacturing (with PhD)
5 years of full-time experience in GMP Manufacturing (with Master's)

Education Level

PhD in a health or science related field
Master’s degree in a health or science related field

Salary/Compensations

$111,387 - $135,829 annually

Benefits

Comprehensive benefits package

About the Company

Health Research, Inc. (HRI) Roswell Park Division is 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.
This is a grant-funded position.
Health Research Inc. (HRI) Roswell Park Division participates in the E-Verify program.

Equal Opportunity

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
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-BenefitsandLeaves@roswellpark.org and let us know the nature of your request and your contact information.