Team Leader
vor 2 Wochen
Position summary
Initially, this position will focus on providing support to the QC Manager for the transition of immunoassays. As the transition is completed, this position will take on responsibility for all the routine immunoassays including method validation and lead a small team within the Immunology platform.
Responsibilities
- Perform immunoassays including antigen and vaccine potency assays (ELISA, flocculation, agglutination assays, etc.)
- Lead a small group within immunoassays platform
- Lead the tech transfer of immunoassays
- Train the QC analyst
- Keep the lab ready for regulatory audits
- Write the validation and tech transfer protocol and report
- 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.
- Support laboratory-based projects
- Maintain laboratory housekeeping
- 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 (Immunology, Pharmaceutical Science, Microbiology, Biology, Biochemistry, etc.)
- 5+ years of experience in the pharmaceutical/veterinary pharmaceutical, biotechnology, or related industry with notable exposure to GMP, GLP, and Immunoassays.
- Extensive experience with veterinary antigen and vaccine potency tests is highly regarded.
- Solid experience with immunoassays validation and tech transfer
- Understanding of the USP, BP & EP pharmacopoeias.
- 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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Team Leader (Immunoassays) (ZOETLI03062024) Parkville, Melbourne, AustraliaPosition summary
Initially, this position will focus on providing support to the QC Manager for the transition of immunoassays. As the transition is completed, this position will take on responsibility for all the routine immunoassays including method validation and lead a small team within the Immunology platform.
Responsibilities
- Perform immunoassays including antigen and vaccine potency assays (ELISA, flocculation, agglutination assays, etc.)
- Lead a small group within immunoassays platform
- Lead the tech transfer of immunoassays
- Train the QC analyst
- Keep the lab ready for regulatory audits
- Write the validation and tech transfer protocol and report
- 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.
- Support laboratory-based projects
- Maintain laboratory housekeeping
- 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 (Immunology, Pharmaceutical Science, Microbiology, Biology, Biochemistry, etc.)
- 5+ years of experience in the pharmaceutical/veterinary pharmaceutical, biotechnology, or related industry with notable exposure to GMP, GLP, and Immunoassays.
- Extensive experience with veterinary antigen and vaccine potency tests is highly regarded.
- Solid experience with immunoassays validation and tech transfer
- Understanding of the USP, BP & EP pharmacopoeias.
- 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:Eligibility: 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. ; Team Leader (Immunoassays) (ZOETLI03062024) Parkville, Melbourne, Australia Thank you for submitting your application. #J-18808-Ljbffr
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