Lead Manufacturing Biotech Associate – MS–D
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Location: Dunboyne, County Meath, Ireland – state‑of‑the‑art single‑use, multi‑product biotech facility.
Job Description
A fantastic opportunity has arisen for a Lead Manufacturing Biotech Associate. You will be part of a self‑directed work team/hub, where decisions are made at the level where the data exists. The role requires strong interpersonal, communication and collaboration skills. You will support the manufacturing process, while creating an inclusive culture that energises Safety First, Quality Always, with a continuous improvement mindset.
Responsibilities
* Carry out and support operations to achieve assigned duties.
* Deliver shift standard work for a team‑based approach to batch progression.
* Document executed activities to ensure proper accountability and traceability of production records (Right First Time).
* Author, review, and/or edit procedures and technical documents to ensure compliance with cGMP requirements.
* Provide coaching to the shift teams on the RFT approach to documentation.
* Ensure that all assigned tasks related to manufacturing documentation support comply with good manufacturing practices.
* Identify, escalations and address compliance, environmental, safety and process deviations as appropriate.
* Support execution of safety walkdowns, audits/inspections, risk assessment, implementation of agreed actions, etc.
* Ensure incident investigations are fully supported with improvement actions implemented and participate in investigations arising from manufacturing documentation aspects as required.
* Coach and provide oversight on the shop floor to identify potential issues before they arise.
* Lead approved projects and continuous improvement initiatives that align with site strategies.
* Run handover boards and provide key updates to shift leads for handover.
* Any other duties as and when assigned by the Manager, including acting as a designee for Manufacturing Shift Lead as required.
Qualifications (What Skills You Will Need)
* Bachelor’s level (8) degree in science, engineering or a related technical discipline, or a Level 7 qualification in science or engineering with at least 5 years’ experience in a GMP regulated environment.
* Minimum of 5 years experience in a regulated GMP environment.
* 3 years experience in the biopharma industry, with direct experience of biologics manufacture desirable.
* Proven record of accomplishments in a regulated industry.
* Strong leadership, communication, safety, quality, and continuous improvement skills.
* Ability to coach teams, review documents, and implement process improvements.
As a company, we are committed to keeping 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 if 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.
Invent solutions to meet unmet healthcare needs – please apply today.
Job Posting End Date: 11/7/2025.
Requisition ID: R369906
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