Job Description
Principal Accountabilities
The Analytical Development and Commercialization (ADC) Laboratory Systems Lead has responsibility for organization and leadership of the ADC Laboratory Systems Group at the Ballydine site in Co. Tipperary.
The Laboratory Systems Lead will manage a team that is responsible to provide laboratory systems support to Ballydine API, OSD, and Clinical Laboratories by maintaining laboratory systems e.g. reference standards, Empower, Stability, Instrumentation, Change Control, SAP, Environmental Monitoring, Instrument Installation and Qualification and Data Integrity support. Capital and expense management for Ballydine ADC department is also within the scope of this role.
* The Laboratory Systems Leader is responsible for ensuring all laboratory systems comply with cGMP, including support to regulatory filings and acting as lead auditee.
* Leads the activities of the Ballydine ADC Systems group, encompassing activities in: Instrumentation, Laboratory Instrumentation Capital and CSV, Stability, Reference Standards, Retain Samples, Regulatory Data Requests, Environmental Monitoring and Change Control.
* Monitors spending and budgets for the department to meet budgetary targets.
* Delivers targets and improvements through the use of appropriate Lean tools such as Problem solving, Leader Standard Work and Standardized work.
* Mentors laboratory systems personnel and provides input and coaching on professional development and career paths.
* Participates in Analytical Development & Commercialization (ADC) Leadership Team supporting management and leadership of the whole ADC department.
Core Competencies
* This position requires a B.Sc. (or equivalent experience base) in analytical chemistry, pharmaceutical science or a related discipline and a minimum of 5 years experience.
* The incumbent must have demonstrated problem solving, communication and people management skills.
* Good understanding of analytical methodology, process optimization support needs and knowledge of relevant regulatory requirements, including GMPs.
* Experience in regulatory inspections is a preference.
* The position requires an ability to lead a laboratory systems team, deal with partners across ADC and other site functions, and works with competing priorities.
* Lean/6-sigma skills are a preference.
We keep the patient at the very heart of all that we do and strive to find solutions and treatments for some of the world's most challenging healthcare needs.
As an equal opportunity employer, we are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. Please don't hesitate to contact the Talent Acquisition Advisor assigned to this role should you need any support during our recruitment process.
We are committed to flexible working where possible, and this is why our Company has introduced a new hybrid working model for office-based colleagues around the world.
Please feel free to speak to us about what flexibility means to you during your application.
So, if you are ready to:
Invent solutions to meet unmet healthcare needs, please apply today.
Current Employees apply HERE
Current Contingent Workers apply HERE
Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
Employee Status:
Regular
Relocation:
VISA Sponsorship:
Travel Requirements:
Flexible Work Arrangements:
Hybrid
Shift:
Valid Driving License:
Hazardous Material(s):
Required Skills:
Analytical Chemistry, Analytical Chemistry, Bioanalytical Techniques, Budget Management, Communication, Cost Management, Dosage Forms, Environmental Monitoring, Experimental Chemistry, Identifying Customer Needs, Instrumental Analysis, Laboratory Information Management System (LIMS), Lean Design, Lean Management, Lean Product Development, Management Process, Medical Laboratories, Medicinal Chemistry, Mentoring Staff, Molecular Structure, People Leadership, People Management, Pharmaceutical Sciences, Qualitative Analysis, Quantitative Analysis {+ 4 more}
Preferred Skills:
Job Posting End Date:
07/10/2025
*A job posting is effective until 11:59:59PM on the day BEFOREthe listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.
Requisition ID:R354141
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