Tommy Carey
Thun,BE
Summary
Experienced Biotech Production Operations manager with over 10 years experience in the area of commercial scale biotechnology processes. Experience in driving success in startup environments. Currently working as a CQV Engineer in Lonza, Visp having previously managed a team of 100 professionals from a technical and operational standpoint.
Overview
12
12
years of professional experience
2011
2011
years of post-secondary education
Work History
CQV Engineer
Lonza
Visp, Switzerland
06.2024 - Current
- Downstream Processing CQV Engineer involved in the commissioning, qualification and validation of all downstream processing equipment.
- Area owner of nine purification vessels comprising of all documentation preparation, review and approval (URS, FMEA, IQ/OQ/PQ).
- Participation in room GMP certification activities involving the handover of equipment to customer following successful commissioning activities.
- Participation in all mechanical completion walkdowns, updating of P&ID documents, raising and closure of punches.
Manager Biotech Production
Regeneron Ireland
Limerick
01.2023 - 06.2024
- Developed strong teams by skilfully recruiting, orienting and training loyal, hard-working employees.
- Ensure highest safety and housekeeping standards maintained.
- Manages commercial scale manufacturing of recombinant proteins. Tracking and trending of relevant technical and business process metrics to ensure department is performing effectively.
- Interfaces with cross functional departments and provides technical input to process issues.
- Represents downstream manufacturing during regulatory audits (internal and external). Performs cGMP audits of production area and leads technical queries.
- Participated in process area start up activities. Mechanical completion walkdown with stakeholders and documentation approvals. Hazop participation and safety walks completed (LOTO).
- Developed recruitment centres to allow for accelerated onboarding within organisation.
Assoc Mgr. Biotech Production
Regeneron Ireland, Biotech
Limerick
10.2021 - 01.2023
Biotech Production Supervisor
Regeneron Ireland
Limerick
05.2020 - 10.2021
- Supervised downstream manufacturing shift comprising of 30 personnel.
- Emphasized culture of safety and quality, with focus of 'right first time'.
- Oversaw daily production schedule execution, providing details in daily meetings ensuring all scheduling and company objectives were met.
- Performance review calibrations to ensure consistent growth and advancement opportunities for direct and indirect reports.
- Collaborated cross functionally with validation, engineering, quality and process science teams offering guidance on various technical aspects of process.
- Led continuous improvement initiatives.
- Supported safety and quality investigations and implemented resulting actions and CAPAs respectively.
Lead Senior Biotech Production Specialist I
Regeneron Ireland
Limerick
01.2018 - 05.2020
- Performed as one of four front line managers as a team lead, overseeing downstream team's processing.
- Acted as primary point of contact for troubleshooting of equipment and providing clarity on technical issues. Primary escalation point for safety and quality concerns on the production floor.
- Organised one to one meetings with direct reports focusing on performance, training, career progression and providing constructive timely feedback for their development within their roles.
- Contributed to SOP creation, manufacturing record creation and being a part of process validation campaigns following successful technical transfer of products.
Biotech Production Specialist (Levels I - III)
Regeneron Ireland
Limerick
04.2015 - 01.2018
- Managed and executed various crucial processes including chromatography (Affinity, Ion-Exchange, Hydrophobic Interaction), Viral Clearance, and Ultra Filtration / Diafiltration processes.
- Completed manufacturing documentation record reviews ensuring strict adherence to regulatory standards.
- Track and manage the flow of documents for Operations
- Liaising with vendors and purchasing of all small equipment for Upstream and Downstream processing areas. Review of and execution of documentation (URS, IQ/OQ protocols).
- Mechanical completion walkdowns of process areas and safety walks prior to commissioning.
- Supported engineering commissioning of process areas during start up activities. IQ/OQ of these areas involving alarm testing, P&ID walkdowns and documentation review.
- GMP Area Release and Product Changeover protocol generation and execution.
Student Chemist
Merck, Sharp & Dohme
Kilsheelan
06.2013 - 10.2013
- Carried out developmental lab runs to generate supporting data for a regulatory filing
- Conducted use-testing of raw materials to lend support to plant personnel
- Preparation and analysis of samples using HPLC, GC and KF instruments with use of several software packages including ELN (Electronic Lab Notebook) & Empower (GC & HPLC systems)
- Carried out preventative maintenance on laboratory equipment and assisted in the troubleshooting of processing issues
Education
MSc - Biotechnology
University College Cork
Cork10.2015
BSc - Chemistry, Pharmaceutical Compounds
University College Cork
Cork10.2014
Leaving Certificate - 500/600 Points
Christian Brothers College
Cork, County Cork08.2010
Professional Diploma in Leadership and Managemnt
University College Dublin
Dublin 01.2022 - 06.2022
Skills
- Chromatography processes; technical and operational executions
- Ultra Diafiltration/Diafiltration processes; technical and operational executions
- Documentation generation/review/execution (URS, IQ/OQ, SRS, MSRA, SOP, manufacturing records, GMP area release)
- Leadership Development
- Organisational Structure
- Technical problem solving
- Compliance knowledge and EDMS proficiency
- Manufacturing process improvements
- Safety process improvements
- Project leadership
Affiliations
- Received ‘College Scholar’ accolade based on BSc The Chemistry of Pharmaceutical
Compounds Year 1 results. - 1996-2011 incl.: Played Hurling and Gaelic Football with Carraig na bhFear GAA Club.
- 2019-2023: Member of CIAC Squash Club.
- Speech and Drama:
- Achieved to Gold Medal in both Acting and Verse & Prose from the London Academy of Music and Dramatic Arts (LAMDA).
Languages
English
Fluent
Irish
Upper intermediate
German
Intermediate
Timeline
CQV Engineer
Lonza
06.2024 - Current
Manager Biotech Production
Regeneron Ireland
01.2023 - 06.2024
Professional Diploma in Leadership and Managemnt
University College Dublin
01.2022 - 06.2022
Assoc Mgr. Biotech Production
Regeneron Ireland, Biotech
10.2021 - 01.2023
Biotech Production Supervisor
Regeneron Ireland
05.2020 - 10.2021
Lead Senior Biotech Production Specialist I
Regeneron Ireland
01.2018 - 05.2020
Biotech Production Specialist (Levels I - III)
Regeneron Ireland
04.2015 - 01.2018
Student Chemist
Merck, Sharp & Dohme
06.2013 - 10.2013
MSc - Biotechnology
University College Cork
BSc - Chemistry, Pharmaceutical Compounds
University College Cork
Leaving Certificate - 500/600 Points
Christian Brothers College
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