LIMS & Lab Support Manager
Merck & Co., Inc. Kenilworth, N.J., U.S.A. known as Merck in the United States and Canada, 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 Merck has codified its legacy for over a century. Merck’s success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.
Merck Manufacturing Division, MMD, is a team of dedicated, energetic individuals who are committed to being the most trusted supplier of pharmaceuticals and health products worldwide. Our facilities, along with our external contractors, suppliers, and partners, comprise an interdependent global manufacturing network that’s committed to delivering a compliant, reliable supply to customers and patients on time, every time, across the globe.
The Laboratory Information Systems (LIMS) and Lab Support Manager is responsible for the overall direction, management and the performance of the current Labware system and for the day to day oversight of the sample management team. Manager responsibilities include supporting site/network business and LIMS administrators in report design and build, updating master data for new and existing products, updating master data for new and existing analysis, maintaining system documentation, and providing ad hoc support to other departments. The position is expected to provide leadership to support system evolution and continuous improvement, and sample management. Responsible for managing direct reports and carrying out supervisory responsibilities in accordance with Merck’s policies.
-Manage the Quality Operation Laboratory system interface with other Merck enterprise systems such as SAP.
- Ensure site on-time implementation of LIMS through support of requirements definition, functional design, master data configuration and data migration, system validation, SOP revisions and development and end-user training. Provide technical support of LIMS to Quality Operation.
- Support business and LIMS Administrator in the creation, validation and maintenance of reports, calculations, queries.
- Provide first level diagnostic of incidents and support end users, LIMS Administrator and Support Center in the management and timely resolution of technical incidents through the standard incident and problem management process.
- Responsible for the master data management process including the updating of specifications and supporting the approval process.
- Site representative for system governance through participation in local, regional and global governance committees.
- Support audits and inspections to provide data and information on request.
- Ensure that the LIMS complies with all relevant regulatory standards Develop and manage improvement projects.
- Support the business in the creation and updating of training materials as changes to system occur.
- Support the business in the delivery of training to end users and support management of associated system training records.
- Write and revise processes and documentation related to LIMS and sample management operations.
- Responsible for efficiently and accurately receive, sort, and login samples for testing on a timely basis with planned distribution of samples to appropriate testing areas.
-Responsible for contacting manufacturing areas when samples/tests discrepancies are observed for timely correction.
-Communicate to Quality Operation management regarding any issues/potential issues with sample management, customer satisfaction, and delays with sample receipt.
-Management of Stability samples receipt and delivery of samples to Quality Operation laboratories for testingeds.
Minimum Education Requirement:
- Bachelor’s Degree or higher in Biological Science
- A minimum of 10 years of LIMS development and implementation experience in the pharmaceutical environment.
- In depth knowledge of laboratory operations and testing with strong understanding of those business units.
- Comprehensive experience in LabWare v6 capabilities in order to support the business in the design of solutions as intended with minimum customization:
- Including but not limited to knowledge and significant experience in
- Developing analyses, product specifications, environmental monitoring, lot manager, project manager, stability manager, storage location manager, reagent and instrument managers, reports and query tools.
- Solid mastery of programming: SQL, LIMS Basic, Instrument Integration/Parsing, Empower and Crystal Reports - certifications in LabWare LIMS Advanced Configuration and Crystal Reporting. - - Extensive experience with CSV (Computer System Lifecycle and Validation), ensuring compliance with regulatory requirements.
- Extensive knowledge of Data Integrity: Ability to demonstrate strong understanding of data integrity, quality, and change management processes in a GxP, CFR Part 11 requirements in a regulated environment.
Preferred Experience and Skills:
- A minimum of 5 years experience directly managing people
- Familiarity with other systems (E.g. Laboratory instrument control and acquisition systems, Empower, Crystal Reports, NuGenesis, TrackWise, SAP)
- Experience in development and delivery of end user training
- Ability to assess processes and workflows to determine opportunities for improvement
- Ability to write UAT scripts and support execution of UAT
- Strong Project Management Skills
Your role at Merck is integral to helping the world meet new breakthroughs that affect generations to come, and we’re counting on your skills and inventiveness to help make meaningful contributions to global medical advancement. At Merck, we’re inventing for life.
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Job: Quality Operations
Employee Status: Regular
Number of Openings:
Shift (if applicable):
Company Trade Name: Merck