Manufacturing/Cell Therapy Associate I
- Employer
- Frederick National Laboratory for Cancer Research
- Location
- Bethesda, Maryland, United States
- Start date
- Oct 21, 2020
View more
- Discipline
- Manufacturing & Production, Manufacturing/Mechanical, Science/R&D
- Required Education
- Bachelors Degree
- Position Type
- Full time
- Hotbed
- BioCapital
Job Details
The Clinical Monitoring Research Program Directorate (CMRPD) provides implementation and oversight of multiple NCI/CCR cell processing facilities within the National Cancer Institute's (NCI's), Center for Cancer Research (CCR), Surgery Branch Cell Production Facility.
KEY ROLES/RESPONSIBILITIES
- Assists with preparation of technical reports, abstracts, presentations and program correspondence concerning assigned projects through research and analysis of information relevant to government policy, regulations and other relevant data and monitors all assigned programs for compliance
- Assists with development and implementation of procedures/programs to ensure effective and efficient business and operational processes
- Helps to identify potential bottlenecks in the upcoming development process and works with all team members and senior management to resolve them
- Assists with coordination of logistics, including purchasing and shipping of miscellaneous equipment, lab and office supplies to ensure compliance with appropriate government regulations
- Maintains workflow and follows timelines to ensure production operations are on schedule and adequate raw materials and supplies are available
- Assists with technical audits of outsourced contractors in conjunction with Quality Assurance and or Quality Control
- Tracks EM samples (testing, results, actions)
- Follows PM schedule and reporting
- The position is located in Bethesda, Maryland
BASIC QUALIFICATIONS
- Possession of a Bachelor's degree from an accredited college/university in a field related to biomedical research/scientific discipline or four (4) years relevant experience in lieu of degree
- Foreign degrees must be evaluated for U.S. equivalency
- No experience is required with a Bachelor's degree (relevant experience may be substituted for the degree)
- Knowledge of production-related principles of biopharmaceutical development and production processes
- Working knowledge of cGMPs as they relate to biopharmaceutical manufacturing
- Use of aseptic/sterile techniques
- Must be able to obtain and maintain a security clearance
PREFERRED QUALIFICATIONS
- Knowledge of handling and propagation of human primary cells, including T cells
- Strict adherence to SOPs and cGMP regulations, including excellent documentation skills
- Proficiency in Microsoft Office® inclusive of Word, Excel, Access and PowerPoint
- Familiarity with interactive databases quality assurance, auditing, metrics analysis, cancer
- Working knowledge of quality systems and regulatory requirements (21 CRF Part 11/210/211)
- Self-motivated and willing to accept/learn temporary responsibilities outside of the initial job description
- Excellent interpersonal, verbal and written communication skills are essential in this collaborative work environment
JOB HAZARDS OR REQUIREMENTS
- 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
Equal Opportunity Employer (EOE) | Minority/Female/Disabled/Veteran (M/F/D/V) | Drug Free Workplace (DFW)
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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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