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Manufacturing Assoicate II/III/IV

Employer
Frederick National Laboratory for Cancer Research
Location
Frederick, MD
Start date
Sep 23, 2022

View more

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

Manufacturing Assoicate II/III/IV

Job ID: req3023
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 Laboratory for Cancer Research (FNLCR) and other government agencies through the development of novel agents for first-in-man clinical studies.

KEY ROLES/RESPONSIBILITIES

Level II

  • Aseptic filling of finished products under cGMP conditions
  • Production of in-process and formulation buffers in support of cGMP manufacturing operations
    document in detail, through the use of master production records or laboratory notebooks, the processes and manufacturing steps taken during processing
  • Set up, maintain and operate equipment used in the formulation and filling of clinical, biological products, including in-process and routine testing
  • Set up, maintain and operate equipment used in the manufacture of buffers used in the manufacture of clinical, biological products
  • Interface with Quality Control/Quality Assurance
  • Write Standard Operating Procedures and complete batch production records

Level III

  • In addition to level II requirements
  • Assume responsibility for unit operations involving aseptic filling and/or buffer preparation
    write Standard Operating Procedures and complete batch production records

Level IV

  • In addition to level III requirements
  • Assume responsibility for unit operations involving aseptic filling and/or buffer preparation
    exercise judgment and use problem solving skills and work independently to troubleshoot problems
  • Perform the above tasks with minimal supervision, and serve as a team leader when needed

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.
    • Mgr II, Manuf- In addition to the education requirement, a minimum of two (2) years of progressively responsible experience
    • Mgr II, Manuf- In addition to the education requirement, a minimum of five (5) years of progressively responsible experience
    • Mgr IV, Manuf- In addition to the education requirement, a minimum of eight (8) 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 / Level IV

  • In addition to level II requirements
  • 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

PREFERRED QUALIFICATIONS

Candidates with these desired skills will be given preferential consideration:  

  • Experience with cGMP manufacturing processes and requirements
  • Experience in aseptic processing
  • Experience in product filling operations

JOB HAZARDS

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