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Form of work* Bring Your Advanced Skills to Where They Can Make the Most Difference: Vaxxas is Hiring a Senior Manufacturing Operator to Champion our Pioneering Vaccine Technology *
Overview of Position
Reporting to the Production Manager, the Senior Manufacturing Operator will be primarily responsible for overseeing the execution of manufacturing plans to enable the manufacture of intermediate and final product, together with the supervision of a team of operators.
Duties & Responsibilities
- Lead the manufacture of clinical product in a sterile cleanroom environment (ISO 5 & ISO 7) and the sampling and packaging of final product.
- Handling of environmental monitoring and quality control samples for in-process and finished product testing.
- Supervise the preparation of equipment and excipient solutions.
- Cleaning of graded cleanroom facilities and laboratory areas.
- Completion of batch documentation to Good Documentation Practice (GDP) standards, together with writing and review of documentation in line with the Quality System, GMP and PIC/s requirements.
- Assist in the validation and qualification activities for facility, equipment, process, and operators.
- Maintaining safety and GMP quality standards.
Qualifications
A relevant undergraduate degree in Science/Engineering (desirable, but not mandatory).
A minimum of 5 years’ experience in a similar manufacturing role either in a pharmaceutical or food environment.
Desired experience and skills
- Demonstrated knowledge of GMP manufacturing processes, materials, product, and process design.
- Experience supervising a production team to manufacture finished product in a cleanroom environment.
- Knowledge of regulatory compliance as specified by various regulatory agencies (e.g. TGA and FDA).
- Experience in problem-solving and root cause analysis techniques.
- Ability to follow set procedures with high attention to detail and accuracy.
- Proficient in Microsoft Office, technical writing and basic laboratory skills and practices.
About Vaxxas
Vaxxas is a privately held, clinical stage biotechnology company focused on enhancing the performance of existing and next-generation vaccines with its proprietary high-density microarray patch (HD-MAP). Vaxxas is targeting initial applications in infectious disease and oncology.
The company’s innovative, needle-free technology can eliminate or significantly reduce the need for vaccine refrigeration during storage and transportation, easing the resource and logistics burden of maintaining the vaccine cold chain.
In addition to a Phase I clinical study of a COVID-19 vaccine candidate, Vaxxas is performing demonstration work in preparation for clinical evaluation under contract with the United States Biomedical Advanced Research and Development Authority (BARDA) on pandemic vaccination solutions, among multiple other clinical and preclinical programs.
The company has forged collaborations with leading global organisations in vaccine commercialisation, including Merck/MSD, CEPI, the World Health Organization (WHO), and the Bill and Melinda Gates Foundation.
Learn more at www.vaxxas.com
Are you ready to make a significant difference in leading manufacturing as a senior operator in a dynamic team, we want to hear from you!
To be considered, please submit your Resume and a cover letter (outlining your core capability for the role, demonstrated experience of how you have delivered outcomes and why this role is of interest) by selecting the “apply for this job” function.
