Manager, Laboratory Systems

Job Description An amazing opportunity has arisen for a Manager, Laboratory Systems. This role will be part of the QC Operations Team, which sits within the Global Quality Large Molecule Analytical Sciences group based at our single-use, multi-product Biologics facility in Dunboyne, County Meath, Ireland. This role will support the QC Testing Team through the leadership and oversight of laboratory system strategy, implementation, upgrades and lifecycle management activities that enable the testing of incoming raw materials, in-process drug substance and drug product, final drug products, stability samples, and environmental monitoring of controlled manufacturing and utilities areas. The position will serve as the Laboratory Systems SME for the QC digital landscape, including Empower, GLIMS/LIMS, SoftMax Pro (SMP), DLR, and MODA, with responsibility for system builds, enhancements, validation, maintenance and continuous improvement. The successful candidate will lead the introduction of new digital capabilities, technology upgrades and automation initiatives that enhance laboratory efficiency, data integrity, connectivity and compliance, while supporting technical transfers, New Product Introductions (NPI), commercial operations and the site's broader digital transformation strategy.

The Laboratory Systems Lead will provide Subject Matter Expert (SME) oversight for laboratory systems supporting qualification/validation, technical transfers, New Product Introductions (NPI), commercial operations, and continuous improvement activities. The role will support the implementation, monitoring, troubleshooting, and ongoing performance of Laboratory Systems at the site in accordance with cGMP and Systems Development Life Cycle (SDLC) standards.

What you will do:

• Be an inspiring member and leader of a high-performing team, with the motivation to continuously learn, improve and develop.
• Lead, coach and motivate assigned employees within the Laboratory Systems team, including management of schedules, 1:1s, check-ins, real-time feedback, Mid-Year and End of Year feedback conversations.
• Support the development and coaching of key members of the Laboratory Systems team to drive a high-performance organizational culture that accommodates rapid growth and dynamic business expectations.
• Be the SME and lead projects on data management systems for instrument control in the laboratories, including but not limited to LIMS, LES, MODA and Empower.
• Support the implementation, monitoring and ongoing performance of Laboratory Systems at the site to cGMP and SDLC standards, including change control, document management, CAPAs and audit readiness.

Educational and Experience Requirements:

Degree qualification in a Technical discipline e.g. (Biochemistry /Chemistry /Engineering). 6-10 years experience in Laboratory Systems. Proven record of accomplishments of working in a GMP Regulated Pharma/Biopharma company or related industry is desirable. Proven record of managing a high functioning team. SME Knowledge on configuring, building, maintaining laboratory management systems such as LIMS/ MODA and /or Empower systems and an interest in coding/ script. An SME understanding in analytical methodology (e.g., HPLC, ELISA, SDS-Page, Glyco analytic, Bioassays, PCR, capillary electrophoresis, compendial assays). An SME understanding of GMP, ICH, USP and global compendia regulations and guidance's, particularly as related to analytical method development and validation. Excellent communication skills (written and oral). Strong technical aptitude (i.e., able to read, write and comprehend technical documentations and execute procedures). Proven ability around working cross functionally, focusing on meeting and tracking to schedules and embracing an interdependent work culture. Organization Skills - Ability to manage multiple priorities and know when to escalating issues for resolution. 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. Flexible and self-motivated Have strong problem solving and trouble shooting skills and be able to lead a team on complex projects Have a strong end to end understanding of digital deployment

Required Skills:

• Aseptic Handling
• Aseptic Handling
• Capillary Electrophoresis (CE)
• cGMP Regulations
• Decision Making
• Digital Transformation
• Environmental Monitoring
• GMP Compliance
• GMP Laboratory
• Immunoprecipitation
• Laboratory Information Management System (LIMS)
• Laboratory Instrumentation
• Laboratory Operations
• Manufacturing Quality Control
• New Product Introduction (NPI)
• Organizational Culture
• People Leadership
• Pharmaceutical Quality Control (QC)
• Pharmacy Regulation
• Polymerase Chain Reaction (PCR)
• Professional Integrity
• Quality Inspections
• Quality Systems Compliance
• Root Cause Analysis (RCA)
• Strategic Planning
• + 1 more

Employee Status: Regular Relocation: VISA Sponsorship: Travel Requirements: Flexible Work Arrangements: Not Applicable Shift: Valid Driving License: Hazardous Material(s):

Our company is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where we have codified our legacy for over a century. Our success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.