Shane O’Sullivan
South Coogee,NSW
Summary
Highly skilled, detail and result oriented professional with over 2 years hands on experience in biopharmaceutical industry. Expertise in clean room and laboratory operations, and quality control and compliance. Adept at conducting experiments, analysing data, and maintaining meticulous records. Highly experienced with daily sampling, cell thawing, inoculation, and use of cutting-edge laboratory equipment. Eager to develop and advance skills and scientific knowledge, while exploring new oppurtunities to broaden and expand my career path.
Overview
2
2
years of professional experience
Work History
Upstream Biotech Production Specialist
Regeneron Pharmaceuticals Inc
08.2020 - 10.2022
- Responsible for all facets of cell culture and media activities in seed, expansion and production bioreactors
- Conducted operations within sterile cleanroom and lab environments, adhering meticulously to aseptic techniques, and maintaining compliance with ISO5, ISO7, and ISO8 standards
- Collaborated with a team in fast-paced environment, ensuring daily and weekly targets were met
- Actively participated in both internal and external audit processes, contributing to quality assurance and adherence to industry standards
- Selected as “Top Talent”, by Manufacturing Supervisor, receiving recognition among shift members for outstanding performance during the 2021/2022 calendar year
- Qualified trainer, contributing expertise to the training of new team members and ensuring a smooth onboarding process
- Held the role of Continuous Improvement agent, actively engaged in fostering process enhancements and efficiencies among team members
- Integral role in manufacturing of various antibody cocktails – including novel COVID-19 antiviral, REGN-COV2
- Reviewed, edited, completed, and revised completed batch records, Logbooks, and SOPs in accordance with cGMP standards and compliant with written procedure
- Performed manufacturing level maintenance on production equipment and troubleshooting of any issues
- Collected, trended, and analyzed data generated during production process, proactively identifying out-of-specification occurrences and employing data-driven insights to make informed process decisions
- Performed in-process scheduled sampling, including daily sampling, titer and bioburden samples, and final samples on day of harvest
- Prepared cell culture dilutions and performed manual cell counts on samples determining cell viability
- Utilised NOVA Flex 2 for in depth cell culture analysis, measuring cell viability, densities, pH/gas levels, key chemistries, ensuring precise process monitoring and control
Education
Bachelor of Science - Bioscience
University of Limerick
Limerick08.2020
Skills
- Biotechnology and molecular biology
- Drug manufacturing
- Quality Control & Assurance
- Laboratory techniques
- Lab safety and regulatory compliance
- Good manufacturing practices
- Data analysis and reporting
- Project management and implication
- Sample preparation
- Equipment maintenance & calibration
Timeline
Upstream Biotech Production Specialist
Regeneron Pharmaceuticals Inc
08.2020 - 10.2022
Bachelor of Science - Bioscience
University of Limerick
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