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Manufacturing Associate I

Employer
Frederick National Laboratory for Cancer Research
Location
Bethesda, MD
Start date
Feb 4, 2023

View more

Discipline
Manufacturing & Production, Manufacturing/Mechanical
Required Education
Bachelors Degree
Position Type
Full time
Hotbed
BioCapital

Job Details

Manufacturing Associate I

Job ID: req3250
Employee Type: nonexempt full-time
Division: Clinical Research Program
Facility: NIH
Location: NIH Campus 9000 Rockville Pike, Bethesda, MD 20892 USA

The Frederick National Laboratory is a Federally Funded Research and Development Center (FFRDC) sponsored by the National Cancer Institute (NCI) and operated by Leidos Biomedical Research, Inc.  The lab addresses some of the most urgent and intractable problems in the biomedical sciences in cancer and AIDS, drug development and first-in-human clinical trials, applications of nanotechnology in medicine, and rapid response to emerging threats of infectious diseases.

Accountability, Compassion, Collaboration, Dedication, Integrity and Versatility; it's the FNL way.

PROGRAM DESCRIPTION

Within Leidos Biomedical Research Inc., the Clinical Research Directorate (CRD), various clinical support teams provide high-quality comprehensive and strategic operational support to the high-profile domestic and international clinical research initiatives of the National Cancer Institute (NCI), National Institute of Allergy and Infectious Diseases (NIAID), Clinical Center (CC), National Heart, Lung and Blood Institute (NHLBI), National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), National Center for Advancing Translational Sciences (NCATS), National Institute of Neurological Disorders and Stroke (NINDS), the National Institute of Mental Health (NIMH) and the National Institute of Environmental Health Sciences (NIEHS). CRD’s support services are strategically aligned with the program’s mission to provide comprehensive, dedicated support to assist National Institutes of Health (NIH) researchers in providing the highest quality of clinical research in compliance with applicable regulations and guidelines, maintaining data integrity, and protecting human subjects. For the scientific advancement of clinical research, CRD services include comprehensive clinical trials monitoring, regulatory, pharmacovigilance, protocol navigation and development, and programmatic and project management support for facilitating the conduct of 400+ Phase I, II, and III domestic and international trials on a yearly basis. These trials investigate the prevention, diagnosis, treatment of, and therapies for cancer, influenza, HIV, and other infectious diseases and viruses such as hepatitis C, tuberculosis, malaria, and Ebola virus; heart, lung, and blood diseases and conditions; parasitic infections; rheumatic and inflammatory diseases; and rare and neglected diseases. CRD’s collaborative approach to clinical research and the expertise and dedication of staff to the continuation and success of the program’s mission has contributed to improving the overall standards of public health on a global scale.

The Clinical Monitoring Research Program Directorate (CMRPD) provides support of innovative T-cell therapies and vector production for cancer treatment facilities within the National Cancer Institute’s (NCI’s), Center for Cancer Research (CCR), Surgery Branch (SB), Cell Production Facility.

KEY ROLES/RESPONSIBILITIES

  • Provides support to ancillary cell production activities with opportunity for progressive training and contributions to cGMP manufacturing runs for cell therapy pipelines
  • Assists with writing and reviewing of Standard Operating Procedures (SOPs)
  • 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
  • Performs aseptic cellular processing of patient materials in the ISO 5 biosafety cabinet (BSC) of a current Good
  • Manufacturing Practices (cGMP) production facility
  • Assists, verifies, and documents aseptic processes performed in the ISO 5 BSC of a cGMP production facility
  • Maintains workflow and follows timelines to ensure production operations are on schedule and adequate raw materials and supplies are available including the inventory of reagents and cellular material in the biorepository
  • Assist with biorepository maintenance, tracking, and updating
  • Assists with technical audits of outsourced contractors in conjunction with Quality Assurance and or Quality Control
  • Performs Environmental Monitoring (EM) sampling and tracking of data (including testing, results, implementing corrective actions)
  • Follows laboratory equipment Preventative Maintenance (PM) schedule and reporting
  • The position is located in Bethesda, Maryland

BASIC QUALIFICATIONS

To be considered for this position, you must minimally meet the knowledge, skills, and abilities listed below:

  • Possession of a (CHEA) 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
  • Possess knowledge of laboratory processes and strict laboratory/production record keeping practices production-related principles of biopharmaceutical development and production processes
  • Use of aseptic/sterile techniques in cell culture or BSC/ISO 5 processes
  • 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
  • Ability to work daily in a restricted access laboratory setting continuously for up to 4 hrs
  • Strict adherence to SOPs and cGMP regulations, including excellent documentation skills
  • Highly organized and able to work under observation and supervision
  • Proficiency in Microsoft Office® inclusive of Word, Excel, Access, and PowerPoint
  • Ability to obtain and maintain a security clearance

PREFERRED QUALIFICATIONS

Candidates with these desired skills will be given preferential consideration:

  • Knowledge of handling and propagation of human primary cells, including T cells
  • Working knowledge of cGMPs as they relate to biopharmaceutical manufacturing
  • Familiarity with interactive databases quality assurance, auditing, metrics analysis, cancer
  • Working knowledge of quality systems and regulatory requirements (21 CRF Part 11/210/211)

JOB HARZARDS 

  • This position is subject to working with or have potential for exposure to infectious
    material, requiring medical clearance and immunizations

Equal Opportunity Employer (EOE) | Minority/Female/Disabled/Veteran (M/F/D/V) | Drug Free Workplace (DFW)

#readytowork

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

 

 

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Company info
Website
Phone
301-846-1000
Location
8560 Progress Drive
Frederick
MD
21701
US

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