Team Leader
vor 2 Wochen
Position summary
Initially, this position will focus on providing support to the QC Manager for the transition of Viral product testing including the commissioning of a viral lab, inactivation of antigens test, virus cell culture assay to determine the virus titre, and extraneous substances. As the transition is completed, this position will take on responsibility for all the routine testing including method validation, laboratory compliance, lead a small team.
Responsibilities
- Perform routine testing including inactivation of viral antigen, virus cell culture assay for potency estimation, extraneous agents, mycoplasma screening, etc
- Assist in commissioning a new viral product testing lab
- Lead the viral products testing method transfer
- Leading laboratory-based projects (viral products)
- Keep lab ready for regulatory audits (APVMA/TGA)
- Lead and manage a small group in Virology lab
- Train up the analysts
- Update specifications and test records as required
- Participate in additional product testing, such as stability samples as required
- Ensure efficient, precise, and accurate reporting of test results in LIMS.
- Participate in laboratory investigations for out of specification results, deviations, and non-conformances
- Support analyst training as required.
- Maintain laboratory quality standards by ensuring a high standard of work conducted at all times.
- Assist with preparing, reviewing, and updating Standard Operating Procedures and Procedures and forms for Testing.
- Ensure equipment and facilities are maintained/prepared in accordance with approved procedures.
- Adhere to GMP and GLP principles
Education and experience
- Bachelor’s degree in science or a relevant scientific discipline (Virology, Pharmaceutical Science, Microbiology, Biology, Biochemistry, etc.)
- 5+ years of hands-on experience in the pharmaceutical/veterinary pharmaceutical, biotechnology, or related industry with notable exposure to GMP, GLP, and viral product (vaccine/antigen) testing.
- Practical experience with a virology lab specifically viral antigen/vaccine testing and cell culture assay is MUST.
- Practical experience with Viral test method validation/verification including protocol and report writing is essential.
- Practical experience with analytical method transfer is essential.
- Understanding of the USP, BP & EP pharmacopoeias.
- Knowledge of GMP, GLP, aseptic technique, and the regulatory environment.
- Understanding of Viral Product Testing Requirements.
- The successful applicant will need to be Covid 19 X 2 vaccinated and be prepared to have tetanus vaccination due to workplace conditions.
- Given the role responsibilities the incumbent is required to work on site every day.
Please include your first and last name.
Email: @
Phone:
Please include your country code.
CV / Resume:
Yes, I am currently eligible to work (work permit/visa/citizenship) in the country to which I am applying. No, I am not currently eligible to work (work permit/visa/citizenship) in the country to which I am applying.
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