Upstream Specialist

Job Locations US-MD-Silver Spring
# of Openings
1
Category
WRAIR PBF
Type
Regular Full-Time

Overview

CAMRIS International, LLC is a medical research and development firm that realizes innovative solutions to health and development challenges through high-quality, cost-effective program and research management services. We combine our proven systems with today’s most effective, evidence-based best practices to improve the lives of people around the world. Our core practice areas include HIV/AIDS, microbiology and infectious disease research, vaccine research, development and production, global health security, biodefense, and clinical research. 

 

We are seeking an Upstream Specialist to support the Pilot Bioproduction Facility (PBF) at the Walter Reed Army Institute of Research (WRAIR) in Silver Spring, Maryland.

Responsibilities

  • Prepare cell culture for virus inoculation and prepare viral seeds
    • Experience and knowledge of current Good Manufacturing Procedures (cGMP), specifically bioproduction of viral vaccines.
    • Execute and participate in cGMP viral growth, virus vaccine purification for cGMP vaccine bioproduction.
    • Aseptic gowning, aseptic processing, aseptic final filtration and working in a cleanroom environment.
    • Cell culture experience (adherent cells a plus), washing and counting cells, repeated trypsin manipulations.
    • Maintain virus vaccine bioproduction inventory; order equipment and reagents.
    • Train on SOPs and fill out Batch Production Records; may perform data entry into hard copy forms or electronic in compliance with cGMP using LIMS system.
    • Comply with cGMP standards for documentation and reagent production.
  • Provide input on cell culture, bioproduction and purification of mammalian cell-based products.
  • Adhere to cGMP guidelines and FDA regulations as they apply to all levels of work.
  • Maintains a safe workplace ensuring that he/she is aware of and observes appropriate safety and occupational health rules and regulations. Employee is required to attend safety training relative to his/her position and report any infractions of safety procedures to the facility Safety Officer.
  • Performs light duties and other related duties as required and assigned.

Qualifications

  • BS degree in biology or equivalent experience in leu of degree. An MS degree or better is a plus.
  • Two years of industry experience performing cell culture and cGMP production in a clean room environment.
  • Electronic batch record documentation a plus.
  • Professional knowledge and experience requirements related to viral product safety for product release and downstream purification (chromatography) a plus.
  • Experience with aseptic gowning, aseptic processing, aseptic final filtration and working in a cleanroom environment.
  • Experience with bioproduction equipment: centrifuges, tangential flow filters, spectrophotometer, biosafety cabinets, sonicator, autoclave, roller bottles a plus.
  • cGMP experience for large scale viral production of biological products a plus.
  • Working knowledge of disposable manufacturing methodology such as the use of sterile bags with tubing and tubing welders is a definite plus.
  • Hepatitis B immunity is a must and vaccinations will be offered.
  • Must be able to work independently following a brief period of specific technical training.
  • Must have proficiency with various types of office software: Outlook, Word, Excel. MS Project, LIMS experience, equipment monitoring systems a plus.
  • Must have ability to follow directions, written policies and procedures for work responsibilities.
  • Licensed vaccinations might be required to work with certain viral agents.
  • Must have good people and communication skills (written and verbal).

CAMRIS International, LLC offers competitive salaries and comprehensive benefits. Please submit your resume online at CAMRIS.com. CAMRIS is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, age, protected veteran status, disability status, or any other characteristic protected by any applicable federal, state, or local law.

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