GMP Materials Specialist & Lab Technician - TPP - Temporary

Fred Hutchinson Cancer Center is an independent, nonprofit organization providing adult cancer treatment and groundbreaking research focused on cancer and infectious diseases. Based in Seattle, Fred Hutch is the only National Cancer Institute-designated cancer center in Washington.

With a track record of global leadership in bone marrow transplantation, HIV/AIDS prevention, immunotherapy and COVID-19 vaccines, Fred Hutch has earned a reputation as one of the world’s leading cancer, infectious disease and biomedical research centers. Fred Hutch operates eight clinical care sites that provide medical oncology, infusion, radiation, proton therapy and related services, and network affiliations with hospitals in five states. Together, our fully integrated research and clinical care teams seek to discover new cures to the world’s deadliest diseases and make life beyond cancer a reality.

At Fred Hutch we value collaboration, compassion, determination, excellence, innovation, integrity and respect. Our mission is directly tied to the humanity, dignity and inherent value of each employee, patient, community member and supporter. Our commitment to learning across our differences and similarities make us stronger. We seek employees who bring different and innovative ways of seeing the world and solving problems.

The Therapeutic Products Program at Fred Hutch Cancer Center provides facilities and services in process development and manufacturing of Good Manufacturing Practice (GMP)-grade cellular therapeutic products for Phase 1/2 clinical trials. Our vision is to support the translation of ideas from academic laboratories to clinical trials.

We are currently recruiting for a GMP Materials Specialist & Lab Technician who will join our Manufacturing Team and continue advancing novel cell therapy products from development into clinic. Primary responsibilities will include supporting clinical manufacturing operations through GMP materials control activities. Laboratory technician responsibilities are also required of this role, providing hands-on support for cellular processing. This role helps enable the production of cellular and gene therapy products for patients enrolled in clinical trials by ensuring compliant cleanroom operations, accurate materials management, and adherence to current Good Manufacturing Practices (cGMP). This position works in a highly regulated environment and requires strong attention to detail, organization, and a commitment to safety and quality.

The GMP Materials Specialist is responsible for supporting clinical manufacturing operations through GMP materials control activities. Laboratory technician responsibilities are also required of this role, providing hands-on support for cellular processing. This role helps enable the production of cellular and gene therapy products for patients enrolled in clinical trials by ensuring compliant cleanroom operations, accurate materials management, and adherence to current Good Manufacturing Practices (cGMP). This position works in a highly regulated environment and requires strong attention to detail, organization, and a commitment to safety and quality.

At Fred Hutchinson Cancer Center, all employees are expected to demonstrate a commitment to our values of collaboration, compassion, determination, excellence, innovation, integrity, and respect.

GMP Materials Control

• Perform GMP materials workflows including receipt, inspection, identification, quarantine, release, storage, and issuance of raw materials.
• Monitor inventory levels, place orders, and manage materials required for manufacturing operations.
• Maintain organized and sanitary storage areas and ensure material status, location, and quantities are accurate.
• Perform inventory transactions in electronic inventory management systems.
• Conduct cycle counts, resolve inventory discrepancy issues.
• Support final product shipping and distribution activities.
• Ensure proper function and maintenance of storage equipment such as fridges and freezers in accordance with quality standards.

Cellular Processing and Cleanroom Support

• Perform support tasks for clinical manufacturing activities in a cleanroom environment in accordance with cGMP and internal Standard Operating Procedures (SOPs).
• Maintain cleanliness and organization of processing areas, including cleaning equipment such as trap flasks, water baths, cryogenic containers, and aspirating lines, and preparing items for sterilization.
• Stock and maintain adequate levels of PPE, cleanroom garments, and sanitization supplies in airlocks, gowning rooms, and processing areas.
• Prepare and maintain formulation and processing supplies, inventory stock, and communicate material needs to schedulers or designees.
• Identify and communicate equipment malfunctions and operational issues.
• Other duties as assigned.

SCOPE OF RESPONSIBILITY:

• This role is responsible for performing tasks maintaining GMP Materials control and manufacturing support per established standard operating procedures (SOPs) and accurate inventory management. Commitment to uphold our quality system is also expected of this role.

MINIMUM QUALIFICATIONS:

• Associate degree or higher.
• 1 – 2 years of experience in a regulated environment preferred (biopharmaceuticals, biotech, or similar).
• Experience in laboratory, cleanroom, or materials control environments preferred.
• Strong attention to detail and ability to work efficiently in a highly regulated setting.
• Strong time management, organization, and teamwork skills
• Effective verbal and written communication skills.
• Basic computer proficiency (MS Office and inventory systems)
  

The hourly pay range for this position is from $31.83 to $47.73 and pay offered will be based on experience and qualifications.

Although Fred Hutch is not sponsoring most H-1B visas at this time, candidates who already hold an H-1B sponsored by another organization and are currently in the U.S. may be eligible for this position.

Fred Hutchinson Cancer Center offers employees access to a retirement savings plan, an employee assistance program, paid sick leave (1 hour for every 30 hours worked), and prorated paid holidays (up to 11 days per year).