Adam Bergin McKiernan
Blanchardstown
Summary
Accomplished Analytical Chemist with a robust background in chromatography (HPLC/GC), method validation, and laboratory instrumentation honed at companies like Merck KGaA. Excelled in employee training and project management, demonstrating exceptional interpersonal skills and a commitment to GMP/GLP standards. Proven track record of enhancing analytical accuracy and efficiency. Currently looking for a long term position to grow and develop skills further.
Overview
5
5
years of professional experience
Work History
Analytical R&D Chemist
SK Biotek
Swords
01.2024 - Current
- Currently working on the AR&D team, validating and developing methods for a custom Cytotoxic product using both Waters and Agilent HPLC/GC systems.
- Preparing sample and standard solutions for HPLC testing in BAND 5 containment facility. Performing all duties safely and carefully using a pressurized glovebox.
- Develop, perform, and validate analytical testing methods for new drug products.
- Evaluate the performance of the method under certain conditions: Accuracy, Precision, Specificity, Linearity, Range, LOD/LOQ, and Robustness.
- Liaise with customers on method requirements and drafting of the validation protocols.
- Engaging with all on-site EHS and Quality training programs.
- Currently being trained on NMR and LC/GCMS.
QCAS Senior Instrumentation Specialist
Bristol Myers Squibb
Cruiserath
03.2023 - 01.2024
- Reviewed and approved scheduled PM/PVs on a wide range of QC instruments in line with company procedures.
- Hosted external vendors on-site and ensured safe work practices were followed at all times.
- Managed vendors' performance of PM/PVs, IOQs, RQs, decommissioning, and unplanned maintenance. Ensuring an orderly and efficient process from start to finish.
- Liaised with QC laboratory management and staff on the instrument needs in the lab, often scheduling vendors onsite to perform necessary actions.
- Engaged in all required on-site GMP/GLP/EHS training and scheduled meetings.
- Led a monthly laboratory representative meeting on instrumentation issues, escalating all issues found to management in a timely manner.
- Use laboratory software applications in the review, release, and management of all things instrumentation, including EmPower, CIMS, Docman, etc.
- Created and reviewed supporting documents for the qualification of instruments, including QSRs, DQs, IOQs, etc.
- Worked in tandem with QC separations, micro, bioassay, environmental, and raw materials labs on a daily basis.
- Worked on several projects within the team, including document archival, portable equipment management, and updating the way we managed pipettes in the labs.
- Engaged in the support of laboratory change controls, QRAs, and deviations when required.
- Always performed duties in accordance with GMP standards, policies, and regulatory guidelines to promote a safe working environment.
- Supported external and internal audits when required.
QC Instrumentation Technician
Merck KGaA
Arklow
06.2022 - 03.2023
- Performed regular calibration on a wide range of QC laboratory instruments and equipment
- Including; FTIR, UV, KF, HPLC/UHPLC, GC, DSC, Melting Point, Analytical/ Micro Balances, Density Meter, Turbidity Meter and more
- Managed and coordinate with Instrumentation team on the scheduling of calibrations in the laboratory
- Also changing the frequencies of calibrations where needed with Quality Management approval
- Primary trainer of all QC analysts in the laboratory
- Ensuring all new staff are trained in various instruments and methods in line with company procedures
- Work to ensure a positive and hassle-free induction for all newcomers
- Heavily involved in IQ/OQ of all new instruments installed in the QC and PTG laboratories
- Coordinating with external vendors such as Masons, Mettler, Agilent and more
- Dealt with external vendors to come on site to perform yearly PMs and general maintenance/ troubleshooting including Suez, Sotax and Agilent
- Performed general maintenance and troubleshooting of instruments and equipment to assist QC analysts
- Writing and approving analytical methods for GC/ HPLC including Assays, Related Substances, Residual Solvents, etc
- Tracked the down time of instruments in the QC lab and relaying common problems identified to Quality management
QC Laboratory Apprentice
Merck KGaA
Arklow
09.2019 - 06.2022
- Gained great experience in running HPLC/ GC testing for API finished product and raw materials
- Performed Related Substances, Residual Solvent and Assay tests
- Also gaining experience in both normal and reverse phase chromatography
- Worked on the QC stability team performing analysis on a wide range of products and chemicals using laboratory instruments and equipment
- Operated many instruments over the course of the apprenticeship program, becoming quite competent in IR/ UV spectroscopy, Karl Fischer analysis, titrations pH testing, DSC, Turbidity and general wet chemistry testing
- Gained excellent experience working in lean six sigma and GMP environments, obtaining a Yellow Belt certification
- Always performing duties in accordance with GMP standards, policies and regulatory guidelines to promote safe working environment
- Carried out daily testing duties in our waste-water treatment plant laboratory accurately and efficiently for a year
- Successfully completed several projects relating to 5S and chemical waste disposal as workplace based learning programs for university
- Often resolved routine issues and escalated non-standard or critical issues to QC/ QA department management for corrective action
Education
Batchelor of Science - BS - Pharmaceutical Sciences
Technological University Dublin
Tallaght10.2022
Leaving Certificate -
Arklow CBS
Arklow, Co. Wicklow06.2017
Skills
- Employee Training
- Chromatography (HPLC/GC)
- Data Analysis/ Statistics
- Microsoft Applications
- Instrument Calibrations
- GMP/GLP
- Team Player
- Interpersonal Skills
- Laboratory Software Applications
- QC Analysis
- GMP Documentation
- Professionalism
- Time Keeping
- Task Prioritizing
- Independent Work Ethic
- Method Validation
- Method Development
- Analytical chemistry
- Managing projects
Hobbies and Interests
- Travelling
- Experiencing New Cultures
- Social Events
- Running
- Video Games
- Reading
- Music
References
References available upon request
Personal Information
Nationality: Irish
Timeline
Analytical R&D Chemist
SK Biotek
01.2024 - Current
QCAS Senior Instrumentation Specialist
Bristol Myers Squibb
03.2023 - 01.2024
QC Instrumentation Technician
Merck KGaA
06.2022 - 03.2023
QC Laboratory Apprentice
Merck KGaA
09.2019 - 06.2022
Batchelor of Science - BS - Pharmaceutical Sciences
Technological University Dublin
Leaving Certificate -
Arklow CBS
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