Manufacturing Associate II-Cell Therapy Specialist
- Employer
- Frederick National Laboratory for Cancer Research
- Location
- Bethesda, MD, USA
- Start date
- Nov 15, 2019
View more
- Discipline
- Manufacturing & Production, Manufacturing/Mechanical, Science/R&D
- Required Education
- Bachelors Degree
- Position Type
- Full time
- Hotbed
- BioCapital
Job Details
The Clinical Research Directorate (CRD) provides cell culture experience to work on innovative Vector Production and T-cell therapies for cancer treatment, and responsible for cell culture media preparation, vector production, and/or cell processing and cell expansion in the cGMP clinical manufacturing facility in support of the National Cancer Institute's (NCI's), Center for Cancer Research (CCR), Surgery Branch (SB).
KEY ROLES/RESPONSIBILITIES
- Performs testing of raw materials, intermediates, and final products by following analytical methods
- Maintains, calibrates and operates equipment and instruments supporting cell bioassays, Flow Cytometry, ELISA and PCR assay
- Tracks and tests products according to protocols
- Maintains lab in an optimal state
- Monitors and trends data, completes routine record review of test data and related documents for in-process testing, drug substance and drug product release
- Generates of CoAs for product release
- Assists in the preparation of dossiers and data packages for interactions between Surgery Branch and Regulatory agencies
- Develops, revises, and reviews SOPs, qualification/validation protocols and reports
- Participates in investigations regarding out of specifications (OOS) results; address and manage deviations related to analytical procedures
- Provides updates at daily and weekly meetings
- Monitors the GMP systems currently in place to ensure compliance with documented policies
- Reviews proposed changes to systems, procedures, methods, and submissions to regulatory agencies, as appropriate
- Gathers metric information for use in continuous improvement of areas of responsibility
- May develop testing and analysis methods and procedures in accordance with established guidelines
- This position is located in Bethesda, Maryland
BASIC QUALIFICATIONS
- Possession of a Bachelor's degree from an accredited college/university according to the Council for Higher Education Accreditation (CHEA) in a related field (Additional qualifying experience may be substituted for the required education)
- Foreign degrees must be evaluated for U.S. equivalency
- In addition to educational requirements, a minimum of two (2) years of progressively responsible job-related experience
- Cell culture processing experience
- Excellent aseptic/sterile techniques
- Experience with handling and propagation of human primary cells, including T cells
- Ability to strictly adhere to SOPs and cGMP regulations and accurately complete documentation associated with clinical manufacturing
- Proficiency in Microsoft Word, Excel and data analysis
- Ability to think critically and demonstrate strong troubleshooting and problem-solving skills
- Must be self-motivated and willing to accept temporary responsibilities outside of initial job description
- Excellent interpersonal, verbal and written communication skills
- Must be able to obtain and maintain a security clearance
PREFERRED QUALIFICATIONS
- Vector production and/or cell therapy products experience
- Working knowledge of quality systems and regulatory requirements (21 CRF Part 11/210/211)
JOB HAZARDS
- Candidate will be working with or have the potential for exposure to infectious material(s) or Other Potentially Infectious Materials (OPIM), requiring medical clearance and immunization in accordance with protocol requirements
- Candidate would be working with radioactive materials and requires them to become an approved radiation worker
Equal Opportunity Employer (EOE) | Minority/Female/Disabled/Veteran (M/F/D/V) | Drug Free Workplace (DFW)
Company
A rewarding career with global impact
Whether you’re an expert in your field or just starting out, we have a career opportunity for you. We’re always looking for people to join us in fulfilling the mission of the Frederick National Laboratory: discovery, innovation, and success in the biomedical sciences.
Our team of 2,400+ scientists, technicians, administrators, and support staff work at the forefront of basic, translational, and preclinical science, with a focus on cancer, AIDS, and other infectious diseases.
We collaborate with colleagues across the National Cancer Institute, National Institutes of Allergy and Infectious Diseases, and others throughout the National Institutes of Health. We also engage with extramural investigators in academia, government and industry.
Your path to joining our team begins with the desire to work for the only national laboratory dedicated to biomedical research. Our employees share a common desire to help make a difference in cancer research and public health concerns. As you search for a career that fits your education, skills, and abilities, explore the core values that guide us and emphasize work-life balance.
Discover why joining the Frederick National Laboratory team could be the most important career step you take
- Website
- https://frederick.cancer.gov/
- Phone
- 301-846-1000
- Location
-
8560 Progress Drive
Frederick
MD
21701
US
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