Lelia Corkery
Glanmire
Summary
Enthusiastic and technically driven with a strong academic and workplace background. A good communicator and recognised as a strong leader and key influencer in the workplace. Systematic and practical with sound judgment, an analytical mindset and good problem-solving skills.
Overview
19
19
years of professional experience
Work History
TECH TRANSFER LEAD, DRUG PRODUCT
BIOMARIN
SHANBALLY
02.2024 - Current
- Lead commercial drug product transfers from CMO to Shanbally
- Documentation creation and closure in adherence with timelines and schedules
- Authoring regulatory submissions for both commercial and clinical
FRONTLINE COMMERICAL LEAD, CELL CULTURE
BIOMARIN
SHANBALLY, CORK
12.2021 - 02.2024
- Process team lead for commerical manufacturing
- Key lead for investigations
- SME approver of all manufacturing documents, CAPA’s and deviations.
- Identifying improvements and advising recommendations.
- Supporting FDA audit inspections
CMO TECH TRANSFER LEAD, FERMENTATION
BIOMARIN
SHANBALLY, CORK
12.2018 - 12.2021
- Lead for fermentation process transfer to CMO
- Key person in plant at CMO to support troubleshooting and investigations.
- SME approver of all CMO documents.
- Authoring Regulatory submissions for commercial supply
SENIOR ASSOCIATE SCIENTIST, CELL CULTURE
BIOMARIN
SHANBALLY, CORK
08.2013 - 07.2017
- Scale down model Qualification
- Troubleshooting and problem solving with a key role in manufacturing investigations.
- Performing data analysis, interpreting, and presenting results.
TSMS ANALYST (LARGE MOLECULE)
ELI LILLY
KINSALE
04.2009 - 08.2013
- Pivotal to initial start-up of successful technical services laboratories
- Development and investigation studies for both fusion protein/ monoclonal antibody production.
BIOPROCESS CELL CULTURE TECHNICAN
PFIZER GRANGE CASTLE
DUBLIN
12.2005 - 02.2008
- Pivotal to a start-up GMP manufacturing facility for fusion protein/antibody production
- Preparation of the operations suite for regulatory inspection.
Education
Master of Science - Biotechnology
National University of Ireland
Galway09-2004
Bachelor of Science - Biochemistry
Cork University College
Cork09-2000
Skills
- Leadership
- Commercial manufacturing
- Tech Transfer
- Scale down models
- Regulatory submissions
- Operational excellence
- Project management
- Communication
- Oral presentations
- Teamwork
- Data Analysis
- Problem Solving
Awards And Qualifications
- LEAN SIX SIGMA YELLOW BELT (CERTIFICATE)
- QUALITY ASSURANCE (CERTIFICATE)
- MSc (BIOTECHNOLOGY) HONOURS DEGREE (2H1)
- BSc (BIOCHEMISTRY) HONOURS DEGREE (2H1)
- HONOURS LEAVING CERTIFICATE (455 POINTS)
References
References available upon request.
Timeline
TECH TRANSFER LEAD, DRUG PRODUCT
BIOMARIN
02.2024 - Current
FRONTLINE COMMERICAL LEAD, CELL CULTURE
BIOMARIN
12.2021 - 02.2024
CMO TECH TRANSFER LEAD, FERMENTATION
BIOMARIN
12.2018 - 12.2021
SENIOR ASSOCIATE SCIENTIST, CELL CULTURE
BIOMARIN
08.2013 - 07.2017
TSMS ANALYST (LARGE MOLECULE)
ELI LILLY
04.2009 - 08.2013
BIOPROCESS CELL CULTURE TECHNICAN
PFIZER GRANGE CASTLE
12.2005 - 02.2008
Master of Science - Biotechnology
National University of Ireland
Bachelor of Science - Biochemistry
Cork University College
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