Downstream Biomanufacturing Researcher
Client: FDA
POP: 12+ months
Location: Silver Spring, MD & Beltsville, MD
Must be able to obtain a FDA clearance
SCOPE
Assist OPQ/OPQR with bioprocessing procedures and testing of new process analytical technologies to support Advanced & Domestic Manufacturing initiatives.
REQUIRED SKILLS
- BA/BS (MS or advanced graduate degree highly preferred) degree in Biochemistry/Cell Biology/Biotechnology/Chemistry/Chemical or Bioengineering or related course of study
- 4 years experience (1 year for MS) in biopharmaceutical manufacturing or quality analytics or biotechnology research and development or other relevant field.
TASKS
- Perform analytical laboratory testing for monoclonal antibodies, therapeutics proteins, and other protein products from multiple sources and compile sample information into multiple databases/data management systems
- Culture mammalian (CHO) cells using aseptic techniques for suspension cell culture for shake flasks, spin flasks, and other industrial techniques
- Perform microbial culture using aseptic techniques including preparation of appropriate liquid and solid media for detection, identification, enumeration, and inactivation procedures
- Operate and maintain benchtop bioreactor systems, including 5L glass bioreactors, disposable wave rocker bioreactors, and disposable micro bioreactors
- Operate and maintain additional laboratory instrumentation including: cell and biochemical analyzer systems, bio-layer interferometer, and protein purification systems
- Assist with ongoing efforts for integration of existing technologies with bioreactor and/or FPLC setups for online sampling
- Assist with laboratory equipment maintenance and repair
- Collect sample information and laboratory testing results from multiple sources and databases
- Perform data processing and analysis of acquired data
- Assist with the upkeep of inventory of lab supplies and laboratory equipment and instrumentation
- Prepare Word summary report or Power Point presentation on work projects and progress when requested by program lead
- Have weekly meetings with program lead for update briefing or issues
- Provide status reports to the program lead according to the schedule provided above
- Write manuscripts and/or technique reports for publications or white papers on the project
- Complete all mandatory FDA training and maintain required credentials
Job Type: Contract
Pay: $40.00 - $45.00 per hour
Schedule:
Education:
Experience:
- Biomanufacturing or Quality Analytics or Biotech R&D: 4 years (Required)
Ability to Relocate:
- Silver Spring, MD: Relocate before starting work (Required)
Work Location: In person