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Manufacturing Associate II / III

Employer
Frederick National Laboratory for Cancer Research
Location
Frederick, MD
Start date
Sep 2, 2022

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

Manufacturing Associate II / III

Job ID: req2495
Employee Type: exempt full-time
Division: Biopharmaceutical Development Program
Facility: Frederick: ATRF
Location: 8560 Progress Dr, Frederick, MD 21701 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      

The Biopharmaceutical Development Program (BDP) of Leidos Biomedical Research, Inc. supports the Frederick National Lab for Cancer Research (FNLCR) and other government agencies through the development of novel agents for first-in-human clinical studies.

KEY ROLES/RESPONSIBILITIES

Level II

  • All phases of production of clinical, biological products under cGMP conditions
    document in detail, through the use of master production records or laboratory notebooks, the processes and manufacturing steps taken during the procedures
  • Exercise judgment and use problem-solving skills to obtain solutions and work independently to determine methods and procedures on new assignments
  • Set up, maintain and operate equipment used in the manufacture of clinical, biological products, including the manufacture of products and in-process testing
  • Interface with Quality Control/Quality Assurance
  • Write Standard Operating Procedures and complete batch production records
  • Assist in the development of procedures to perform cell therapy under cGMP conditions
  • Assist in set-up and commissioning of new cell therapy production suite

Level III

  • All phases of production of clinical, biological products under cGMP conditions
    document in detail, through the use of master production records or laboratory notebooks, the processes and manufacturing steps taken during the procedures
  • Exercise judgment and use problem-solving skills to obtain solutions and work independently to determine methods and procedures on new assignments
  • Train others within the working group
  • Set-up, maintain and operate equipment used in the manufacture of clinical, biological products, including the manufacture of products and in-process testing
  • Interface with Quality Control/Quality Assurance
  • Write Standard Operating Procedures and complete batch production records
  • Assist in the development of procedures to perform cell therapy under cGMP conditions
  • Assist in set up and commissioning of new cell therapy production suites

BASIC QUALIFICATIONS

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

  • Possession of Bachelor’s degree from an accredited college/university according to the Council for Higher Education Accreditation (CHEA) or four (4) years relevant experience in lieu of degree. Foreign degrees must be evaluated for U.S. equivalency.
    • Manufacturing Associate II - In addition to the education requirement, a minimum of two (2) years of progressively responsible experience
    • Manufacturing Associate III - In addition to the education requirement, a minimum of five (5) years of progressively responsible experience

Level II

  • Aseptic technique
  • Ability to work flexible hours including occasional weekends
  • Ability to lift up to 35 pounds and work in a BL2 environment
  • Ability to obtain and maintain a security clearance

Level III

  • Demonstrated experience in the area of operating/maintaining computerized and complex production equipment
  • Experience writing/reviewing technical documents, SOPs and master production records and maintaining accurate documentation of laboratory procedures in accordance with cGMP
  • Working knowledge of cGMP Biopharmaceutical Sciences and operations and department specific computer applications
  • Ability to work flexible hours including occasional weekends
  • Ability to lift up to 35 pounds and work in a BL2 environment
  • Ability to obtain and maintain a security clearance

PREFERRED QUALIFICATIONS

Candidates with these desired skills will be given preferential consideration:

  • Experience with cell therapy equipment and systems
  • Experience in virus production/purification
  • Experience with technical transfer of GMP production processes

JOB HAZARDS

  • This position is subject to working with or have potential for exposure to infectious material, requiring medical clearance and immunizations
  • This position is subject to atmospheric conditions that would require the usage of a respirator, requiring a medical clearance

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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Find Us
Website
Phone
301-846-1000
Location
8560 Progress Drive
Frederick
MD
21701
United States
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