Senior Scientist, Microbiology (Analytical R&D) Full-time

Senior Scientist

An amazing opportunity has arisen for a Senior Scientist, within the Microbiology Laboratory (ARD), at our new state of the art, single use, multi-product facility in Dunboyne, Co. Meath.

In addition to contributing to the establishment and day-to-day operations of our development laboratory you will work across the site and network as part of a diverse and interdisciplinary team to evaluate and implement novel equipment, process and next generation technologies to keep our company at the forefront of innovation in development and manufacturing of biologics. The Microbiology Lab Operations group works closely with Operations to understand facility fit and will be able to flex resources as needed. The group will also have close collaborations with the Enabling Technology and Engineering groups to leverage Process Automation knowledge as well as the Analytical group to enable the adoption of Process Analytical Technology (PAT).

What You Will Do:

• Be able to drive work independently and work as directed by the Associate Principle Scientist according to Company safety policies, cGMP and cGLP.
• Drive compliance with company policies, procedures and guidelines and regulatory requirements and execute Good Manufacturing Practices (cGMP) in the performance of day to day activities and all applicable job functions.
• Participates in the method transfer of analytical techniques for Microbiology testing.
• Plan and perform multiple, complex routine/ non-routine methods and procedure when required.
• Participate in the peer review of analytical data.
• Provide technical guidance and apply expertise and critical thinking to help to resolve technical issues.
• Lead training of staff on technical aspects of the role.
• Revise and implement procedures that comply with appropriate regulatory requirements.
• Support approval of qualification of analytical equipment and related testing functions.
• Compliance with Standard Operating Procedures and registered specifications.
• Maintain quality systems within the laboratories to ensure ongoing compliance to cGLP and cGMP.
• Participate in laboratory investigation reports and deviations through the non-conformance procedures.
• Participate in the generation and update of SOP's, trend data, investigations, validation protocols, reports, method validation/verifications and equipment qualifications (PQ).
• Contribute to the achievements of department productivity and quality goals.
• Provide support with audit/inspection requirements to ensure department compliance/readiness.
• Plan and maintain the laboratory testing schedule to achieve an efficient lean lab system.
• Maintain good housekeeping and hygiene within the laboratory.
• Participate in risk assessments, inspections, audits, incident investigations, etc. and implement and follow-up on corrective/preventative measures.
• Participate in internal and external audits and inspections, taking the role of auditee for assigned areas of responsibility.
• Drive continuous improvement, perform root cause analysis on system failures and substandard equipment performance, using standard tools and methods, to resolve machine and system issues.

What Skills You Will Need:

• A degree qualification in a relevant field (Science/Technical). An Advanced Degree (MSc) qualification is desirable.
• A minimum of 5+ years experience working in a relevant academic or industry field.
• Technical knowledge with biologics drug substance analytical testing.
• Knowledge of design and operation of automated systems such as GLIMS, trackwise and E-logs.
• Ability to think logically and be proactive under pressure.
• Ability to work as part of a team and on own initiative in a constructive manner.
• Excellent trouble shooting and problem-solving skills as well as influencing, collaboration skills and teamworking ability to work with global and interdisciplinary teams.
• Effective communicator and deep technical expertise in science, to be able to share and communicate that knowledge through training other analysts.

We keep the patient at the very heart of all that we do and strive to find solutions and treatments for some of the world's most challenging healthcare needs. We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment.

So, if you are ready to:

Invent solutions to meet unmet healthcare needs, Impact the future by driving one of the world's leading healthcare companies, and inspire your team to reach their full potential and push the boundaries of science and technology, please apply today.

Required Skills: Accountability, Adaptability, Analytical Method Development, Assay Development, Bioanalytical Analysis, Biochemical Assays, Cell-Based Assays, GMP Environments, Incident Investigations, Innovation, Internal Auditing, Laboratory Testing, Manufacturing Compliance, Microbiology, Process Analytical Technology (PAT), Process Automations, Quality Management, Standard Operating Procedure (SOP), Strategic Thinking, Technical Issues, Technical Writing, Test Lab Management

Preferred Skills: