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:

Bring energy, knowledge, innovation and leadership to carry out the following:

• 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 escalate 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:

cGMP regulations, cGMP regulations, GMP laboratory, GMP compliance, Root Cause Analysis (RCA), Digital Transformation, Immunoprecipitation, Sterilization, Capillary Electrophoresis (CE), New Product Introduction (NPI), Laboratory Instrumentation, Laboratory Operations, Laboratory Information Management System (LIMS), Work in Pressure Environments, Pharmacy Regulations, Decision Making, Human Relations Leadership, Strategic Planning, Pharmaceutical Quality Control (QC), Manufacturing Quality Control, Organizational Culture, Polymerase Chain Reaction (PCR), Professional Integrity, Technical Writing, Quality Inspection {+ 1 more}Preferred Skills:

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Recruitment agency representatives, please read the following carefully. 

Merck & Co., Inc., Rahway, NJ, USA (also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA) does not accept assistance from recruitment agencies that have not commissioned us for employment opportunities. Any resumes submitted to our employees by a recruitment agency without a valid written recruitment agreement for this position are considered our property. No commission will be paid without prior agreement, even if we hire a candidate recommended by an agency. If an agency agreement exists, the recommendation is valid only for the relevant position. Do not contact us by phone or email.