Vaccine Manufacturing Purification Associate

Location
Frederick, MD, USA
Posted
Sep 15, 2019
Ref
req698
Hotbed
BioCapital
Required Education
Bachelors Degree
Position Type
Full time
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-THIS POSITION IS CONTINGENT UPON FUNDING APPROVAL
Reporting to the Purification Manager, the Manufacturing Associate I will:
Operate chromatography skids, tangential flow filtration skids, cGMP autoclaves, and basic laboratory equipment
  • Perform chromatography resin packing in various sizes and types of chromatography column hardware
  • Perform in-process sampling
  • Perform operation and changeover of equipment
  • Perform filter integrity testing
  • Follow Standard Operation Procedures (SOP)
  • Complete Batch Production Records under cGMP
  • Document in detail, using Batch Production Records or laboratory notebooks, the processes and manufacturing steps taken during the procedures

BASIC QUALIFICATIONS
  • Possession of a Bachelor's degree from an accredited college or university according to the Council for Higher Education Accreditation. (Additional qualifying experience may be substituted for the required education). Foreign degrees must be evaluated for U.S. equivalency
  • No experience required beyond Bachelor's degree
  • Ability to be gown certified
  • Ability to lift up to 35 pounds
  • This position may require working on 2nd or 3rd shifts and weekends as needed
  • Must be able to obtain and maintain a security clearance

PREFERRED QUALIFICATIONS
  • Working knowledge of cGMPs and computer-assisted manufacturing and production equipment
  • Clean room and BL2 experience
  • Skills/experience in processes and equipment associated with column chromatography techniques from small to pilot scale
  • Experience in the operation of chromatography skids
  • Experience in the operation of tangential flow filtration skids
  • Experience in operation of UnicornTM software
  • Experience in chromatography column packing/qualification

JOB HAZARDS OR REQUIREMENTS
  • Candidate will be working with or have the potential for exposure to infectious material(s) or Other Potentially Infectious Materials (OPIM), requiring medical clearance and immunization in accordance with protocol requirements
Equal Opportunity Employer (EOE) | Minority/Female/Disabled/Veteran (M/F/D/V) | Drug Free Workplace (DFW)