Analytical Scientist

PSC Biotech® Corporation; Carlow; On-site; EUR 65,000 - 90,000; Full time

Job summary

PSC Biotech Corporation in Ireland seeks an experienced Laboratory Analytical Specialist/Analytical Scientist to lead projects in the Analytical Development Lab (ADL). The role focuses on non-commercial and clinical batch analysis within a quality-focused environment.

The ideal candidate has 5+ years in biopharma analytics, strong chromatography and Empower software skills, and proficiency in SOPs and regulatory compliance. A collaborative, cross-functional approach is essential.

Qualifications

• Minimum 5 years' experience as Analytical Scientist in biopharma.
• Knowledge of cGMP and equipment qualification.
• Proficiency with chromatography techniques and Empower software.
• Experience with bioanalytical methods and plate reader assays.

Responsibilities

• Lead analytical development support for non-commercial and clinical batches.
• Lead introduction of new analytical methods to the lab.
• Lead new equipment introductions and instrument validation.
• Troubleshoot product testing and equipment issues.
• Perform wide range of bioanalytical testing (HPLC/UPLC, ELISA).
• Ensure documentation deliverables (SOPs, protocols, reports).

Skills

Analytical Chemistry

cGMP Knowledge

Chromatography

Empower Software

Bioanalytical Methods

Troubleshooting

Quality Systems

Cross-functional Work

Education

BSc/MSc/PhD in relevant field

Tools

Analytical Instrumentation

Job description

Who are we?

PSC Biotech is a leading Biotech Consultancy firm founded in 1996, headquartered in Pomona, California, USA, with Global operations in Ireland, India, Singapore, Australia and the US, serving 350 clients in more than 23 countries worldwide. We provide cloud-based software solutions for Quality Management and Regulatory Inspections, pharmaceuticals contract manufacturing professionals, and metrology services to our clients.

About PSC Biotech

PSC Biotech is a leading Biotech Consultancy firm founded in 1996, headquartered in Pomona, California, USA, with Global operations in Ireland, India, Singapore, Australia and the US, serving 350 clients in more than 23 countries worldwide. We provide cloud-based software solutions for Quality Management and Regulatory Inspections, pharmaceuticals contract manufacturing professionals, and metrology services to our clients.

Take your Career to a new Level

PSC Biotech disrupts the conventional consultancy model by aligning our EVP as one of the unique selling point which includes the opportunity to work with the most talented cohort of like-minded professionals operating in the Pharma/ Biotech Industry. We offer a permanent contract of employment giving exposure of working in Top Pharmaceutical client sites in a diverse-cultural work setting.

Employee Value Proposition

Employees are the “heartbeat” of PSC Biotech, we provide unparalleled empowering career development though Learning & Development in-house training mentorship through constant guidance to facilitate career progression. We believe in creating high performing teams that can exceed our client’s expectations with regards to quality of all scalable and business unit deliverables, staying under budget and ensuring timelines for our deliverables are being met.

Overview:

An amazing opportunity has arisen for a Laboratory Analytical Specialist/Analytical Scientist. The role will be responsible for leading projects within the Technical Operations Analytical Development Lab (ADL). The ADL supports Analytical Testing of non-commercial batches across the Large Molecule Technical Operations network. This role would be ideal for someone with extensive experience working within a Quality laboratory environment who is looking to move into a more project-based team.

Requirements

What you will do:

• The ADL is a non-commercial lab which has responsibility for all aspects of analytical support through development, clinical and commercial stages of new Drug Products on site.


• Lead introduction of new analytical methods to the lab


• Lead new equipment introductions to the lab


• Troubleshooting and problem solving of product testing and equipment issues


• Perform wide range of bioanalytical testing including HPLC/UPLC, CE, ELISA and plate reader assays


• Support launch of new products to site


• Lead and drive continuous improvement solutions to completion.


• Support all documentation deliverables including SOPs, protocols, reports etc


• Continually reviews the analytical elements of projects to assure attention to critical issues and appropriate resourcing (by supporting functions) to meet project needs and timelines


• Leadership activities including project planning and analyst coaching


• Develop and maintain training program


• Lead method remediation solutions


• Work collaboratively to drive a safe and compliant culture

What skills you will need:

• BSc/ MSc/PhD Qualification with minimum of 5 years’ experience as an Analytical Scientist or similar role in biopharmaceutical industry


• Knowledge of cGMP


• Knowledge of equipment qualification


• Extensive knowledge of chromatography techniques and Empower software


• Knowledge of bioanalytical methods including plate reader assays, concentration assays and compendial methods etc.


• Troubleshooting and maintaining instrumentation and equipment


• Knowledge of Laboratory Quality Systems


• Proficiency in Microsoft Office and job-related computer applications


• Effective communication and interpersonal skills to interface effectively with all levels of colleagues in a team environment, and with external customers


• The ability to work cross functionally with all areas of the business


• Self-motivated


• Flexible approach


• Excellent attention to detail


• Demonstrable analytical and systematic problem-solving skills


• Project management skills