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Manufacturing Associate II, Fermentation

Employer
Frederick National Laboratory for Cancer Research
Location
Frederick, MD, USA
Start date
Apr 22, 2019

View more

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

Job Details

The Vaccine Clinical Materials Program (VCMP) is responsible for the overall direction of the operations/manufacturing of the vaccine and biotherapeutic development facility for the development of experimental therapeutics for pre-clinical and Phase I and II clinical trials targeting a range of infectious diseases.

KEY ROLES/RESPONSIBILITIES
  • Support manufacturing laboratory functions
  • Maintain bacterial and mammalian cell cultures
  • Perform microscopic technique/cell counting
  • Operate single use and fixed stainless steel bioreactors, GMP autoclaves and associated equipment, basic lab equipment operation
  • Follow standard operating procedures
  • Complete Batch Production Records under current Good Manufacturing Practices
  • Document in detail, through the use of batch production records or laboratory notebooks, the processes and manufacturing steps taken during the procedures
  • Initiate deviations when atypical events occur, initiate change controls to improve bioprocessing
  • Interface with Quality Control/Quality Assurance,
  • Interact with customers and/or Senior Management
  • This position may be required to work on 2 nd , 3 rd , or weekend shifts as needed

BASIC QUALIFICATIONS
  • Possession of a Bachelor's degree from an accredited college or university (according to CHEA). (Additional qualifying experience may be substituted for the required education). Foreign degrees must be evaluated for U.S. equivalency.
  • A minimum of two (2) years of progressively responsible experience in GMP biotech or cell culture/fermentation
  • Knowledge of the regulatory issues associated with cGMP manufacturing of biopharmaceutical products
  • Knowledge of cGMP's as they relate to manufacturing operations
  • Ability to write and follow standard operating procedures
  • Ability to assist in writing master batch records and complete Batch Production Records under Good Manufacturing Practices
  • Working knowledge of computer assisted manufacturing/production equipment
  • Ability to work in a BL2 environment
  • Ability to lift up to 35 pounds
  • Ability to be gowning certified
  • Must be able to obtain and maintain a security clearance

PREFERRED QUALIFICATIONS
  • Possession of one or more skills in the following areas:
  • Cell culture
  • Fermentation
  • Ability to interface with Quality Control, Quality Assurance, Materials Management

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

 

 

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

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