Materials Specialist

Apr 10, 2021
May 15, 2021
Full Time
The Cellular Therapy Laboratory Materials Specialist will be responsible for managing all materials, storage spaces, and lab areas to enable the research, development, and manufacturing of cellular therapy products in the Cellular Therapy Laboratory, a rapidly growing program with a mission of manufacturing cellular therapies as a cure for cancer and blood disorders. Those with experience in biopharmaceutical, pharmaceutical, cellular therapy, stem cell or clinical laboratory, as well as knowledge of FDA's Good Manufacturing Practices (GMP) and Good Tissue Practices (GTP) or Foundation Accreditation for Cellular Therapy Product (FACT) Standards are encouraged to apply.


Minimum Education
Associate's Degree in Biology (Required)
Bachelor's Degree in Biology Major (Preferred)

Minimum Work Experience
1 year experience in cGMP environment or clinical laboratory (Preferred)

Required Skills/Knowledge
Good knowledge of cGMP and current FDA policies relate to biotech products and sterile drug manufacturing is highly desirable
Previous experience in logistic, distribution, supply chain preferred
Must be able to lift, carry, push and/or pull boxes of supplies
Must be able to squat, bend, kneel, walk, stand and/or move about for 75% of the day

Functional Accountabilities

Job Duties
1. Order, receive, quarantine, inspect, label, release and restock raw materials per established SOP's and controlled material specifications, Order, receive, quarantine, inspect, label, release and restock raw materials per established SOP's and controlled material specifications, specific to Cellular Therapy Lab. Will follow Children's National Supply Chain Department's policies and procedures for procurement and ordering of supplies
2. Assist in the storage of retention samples and final products according to established procedures and conditions.
3. .Maintain accurate inventory database of raw materials, samples and products.
4. Assist in monitoring vendor qualification, change notifications, material availability, resolve issues. Follow Supply Chain Department and Accounts Payable guidelines for request of any new vendors to be added to procurement system.
5. Maintain and keep current of raw material Certificate of Analysis (CofA) and Material Safety Data Sheets (MSDS) if applicable.
6. Transfer of released raw materials at on-campus storage and other CTL locations.
7. Ensure all expired materials from Inventory are identified each month and discarded or transferred to research following SOPs.
8. Keep storage organized and inspection ready at all times.
9. Assist in coordinating product shipments to different sites.
10. Act as a backup for environmental monitoring of the facility.
11. Interact with management, manufacturing, QC, QA, and other staff regarding materials requirements, production schedules, and other considerations to facilitate production processes.
12. Maintain the required technical training and certifications (i.e. cGMP, computer software).
13. Suggest quality, safety, and efficiency improvements (i.e. operational flow, labeling, database).
14. Assist in updating and revising SOPs for the facility operation, especially raw material management.
15. Adhere to all applicable cGMP guidelines, CNH and departmental policies, and CTL SOPs.
16. Other duties as assigned.

Childrens National Hospital is an equal opportunity employer that evaluates qualified applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender, identity, or other characteristics protected by law.

Similar jobs