MSD Senior Scientist BioNX Microbiology Laboratory 

Ireland 

452788510

Job Description

The key deliverables of this position are:

• Lead and act as primary point of contact for laboratory projects, such as new product introduction analysis, method transfers, method verifications, and execution of laboratory studies.
• Take ownership of project deliverables relating to qualification of analytical equipment and associated test methods, driving performance and compliance with Company policies, procedures and applicable GMP and GLP guidelines.
• Lead and coordinate the method transfer of analytical techniques for Microbiology testing, including Rapid Methods, including Planning, performing and troubleshooting multiple complex methods and procedures.
• Participate in the peer review and approval of laboratory data.
• Provide technical guidance and apply expertise and critical thinking to help resolve technical issues.
• Coach and train colleagues and leads by example throughout department improving the quality of both individuals and teams for next scientific role.
• Collaborate cross-functionally with area owners and stakeholders of other departments, acting as a group representative at cross-functional meetings.
• Be a point of support for risk escalation, issue management and mitigation plan development.
• Manage supporting activities for general lab operations, EM, Facility testing, in-process and drug substance analysis studies.
• Oversee the laboratory testing schedule to achieve and maintain an efficient lean lab system - Maintain timelines, manage review and approval of validation and transfer protocols and reports; assist labs with sample/consumable logistics in support of validation and transfer.
• Participate and/or lead risk assessments, inspections, internal and external audits, incident investigations, implement and follow-up on corrective / preventative measures, drive permanent inspection readiness. Drive and lead Safety and quality culture.

Educational and Experience Requirements

• A degree qualification in a relevant field (Biological Sciences/ Engineering), preferable for background in microbiology, An Advanced Degree (e.g., MSc) qualification is desirable.
• A minimum of 5-7+ years experience working in a relevant academic or industry field.
• Technical Knowledge with Biologics drug substance manufacturing and microbiological testing techniques.
• Knowledge in the technical aspects and prior hands-on experience of analytical methods used for release, stability, process monitoring
• Knowledge of design and operation of automated systems such as GLIMS, trackwise and E-logs, SAP.
• 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.
• Effective communicator and deep technical expertise in science, to be able to share and communicate that knowledge through training other analysts.

So, if you are ready to:

Current Contingent Workers apply

*A job posting is effective until 11:59:59PM on the dayBEFOREthe listed job posting end date. Please ensure you apply to a job posting no later than the dayBEFOREthe job posting end date.

A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.