1 year to start
- Perform GMP purification activities to support clinical studies. Perform sampling and sample labeling of test items. Maintain accurate records of all production data. Work requires knowledge of site procedures, GMP regulations, quality compliance, and aseptic techniques.
- Assist with internal and external quality audits, deviation investigations, root cause analysis and the generation of corrective and preventative actions.
- Assist in the development and maintenance of production recipes. In addition maintain material/component stocks and clinical material inventory (physical and SAP), order materials as necessary for clinical purification activities. Work requires knowledge of the SAP system
- Assist with the develop and execution of experiments to purify viral and bacterial antigens for process development. Experiments require knowledge of protein purification, virus purification, and vaccine candidate characterization, wet chemistry, computerized instrumentation and aseptic techniques.
- Assist with the transfer of the process and technologies to the clinical bulk manufacturing platform.
- Assist with the preparation of SOPs, BPRs, protocols
- Support Environmental Monitoring through sampling activities
- Need at least some experience with Downstream processes (Flow filtration, Column Chromatography etc.)
- Sounds knowledge of cGMPs
- Ability to gown-up and wear mask and gloves
- Duration: 1-year to start with possibility of extension
- Level: Junior to intermediate (1 to 5-6 years of experience)
- Shift: Day shift mostly, may need some flexibility to work longer hours at times
- Education: Postgrad or bachelor degree in Biochemistry, Microbiology or Bioengineering