Bioanalytical Professional

About Our Role

We are seeking a skilled Bioanalytical Specialist to join our team. As a Bioanalytical Specialist, you will play a crucial role in ensuring the quality and accuracy of our laboratory testing.

Your primary responsibility will be to perform analytical testing within our Biologics laboratory, using techniques such as HPLC, compendials, UV, raw materials, DNA PCR, and bioassay ELISA testing in compliance with GMP requirements.

You will also be responsible for maintaining good housekeeping and hygiene within the laboratory, calibrating and maintaining all designated laboratory instruments, and participating in risk assessments, inspections, audits, incident investigations, etc.

In addition, you will ensure that training is current for all job functions performed, order and stock laboratory supplies, and maintain data integrity and ensure compliance with company SOPs, specifications, and cGMP regulations.

Key Responsibilities:

• Perform a variety of routine analytical techniques, including but not limited to HPLC, compendials, UV, raw materials, DNA PCR, and bioassay ELISA testing in compliance with GMP requirements.
• Follow up-to-date practices with reference to pharmacopoeias, specifications, regulations, and industry standards.
• Schedule and manage laboratory testing to achieve an efficient QC system.
• Receive and manage samples that come into the lab for stability, in-process, and release testing.
• Reagent preparation, cleaning, and routine equipment maintenance.
• Maintain good housekeeping and hygiene within the laboratory.
• Calibrate and maintain all designated laboratory instruments.
• Participate in risk assessments, inspections, audits, incident investigations, etc., and implement and follow-up on corrective/preventative measures.
• Ensure training is current for all job functions performed.
• Order, stock, and receive laboratory supplies.
• Maintain data integrity and ensure compliance with company SOPs, specifications, and cGMP regulations.

Qualifications and Experience:

• 1-5 years laboratory testing experience in the pharmaceutical industry.
• Relevant experience and skill sets in their area of expertise that adds value to the business; ideally in a manufacturing, preferably in a GMP setting.
• Experience and critical skills in the area of expertise that add value to the business; ideally bioassay and DNA tests.
• Knowledge of regulatory/code requirements to Irish, European, and International Codes, Standards, and Practices.
• Knowledge of cGMP & Laboratory Quality Systems.
• Effective communication, presentation, and interpersonal skills, to interface effectively with all levels of colleagues and with external customers in a team-oriented manner.

Benefits

• Career development opportunities through learning and development in-house training and mentorship.
• A diverse-cultural work setting.

Overview

This is an excellent opportunity to join a leading biotech consultancy firm and contribute to the success of our clients.

We offer a permanent contract of employment with exposure to working in top pharmaceutical client sites in a diverse-cultural work setting.

We believe in creating high-performing teams that can exceed our clients' expectations with regards to quality of all scalable and business unit deliverables, staying under budget, and ensuring timelines for our deliverables are being met.

We are committed to empowering our employees through learning and development in-house training and mentorship, facilitating career progression.

We promote and participate in the implementation and maintenance of relevant safety programs.

We strive to maintain cGMP standards at all times and ensure that our employees are trained and equipped to perform their job functions safely and effectively.