Senior Scientist, Analytical R&D (Dunboyne)
We are looking for a Senior Scientist, Analytical R&D to join our Dunboyne facility, the company’s first Biologics Drug Substance Single Use Commercialisation Facility.
Responsibilities
Drive work independently and by direction of the Microbiology Lead, complying with company safety policies, cGMP and cGLP.
Drive compliance with policies, procedures, guidelines and regulatory requirements and execute Good Manufacturing Practices (cGMP) in day‑to‑day activities.
Lead and coordinate the method transfer of analytical techniques for Microbiology testing, including Rapid Methods.
Plan, perform and troubleshoot multiple, complex methods and procedures where required.
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 the department, improving the quality of both individuals and teams.
Oversee and guide implementation of procedures that comply with appropriate regulatory requirements.
Manage project deliverables relating to qualification of analytical equipment and associated test methods.
Ensure quality systems within the laboratories are within compliance to cGLP and cGMP, performing administrator tasks where required.
Collaborate cross‑functionally with area owners and stakeholders to ensure compliant laboratory operations.
Manage supporting activities for general lab operations, EM, Facility testing, in‑process and drug substance analysis studies.
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.
Drive and lead Safety and quality culture.
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.
Drive good housekeeping and hygiene standards within the laboratory.
Participate and/or lead risk assessments, inspections, audits, incident investigations, implement and follow up on corrective / preventative measures, and drive permanent inspection readiness.
Participate in internal and external audits and inspections, contributing as Subject Matter Expert for assigned areas of responsibility.
Communicate effectively across functions and departments to assist management and governance teams in risk escalation, issue management and mitigation plan development.
Qualifications
A degree qualification in a relevant field (Biological Sciences/Engineering), preferable with a background in microbiology; an advanced degree (e.g., MSc) is desirable.
Minimum of 5–7+ years of experience working in a relevant academic or industry field.
Technical knowledge with Biologics drug substance manufacturing and microbiological testing techniques.
Knowledge of the technical aspects and hands‑on experience of analytical methods used for release, stability and 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, capable of sharing and communicating that knowledge through training of other analysts.
As an equal‑opportunity employer, we are proud to embrace diverse talent and provide a workplace that supports inclusive growth.
Requisition ID: R398778
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