Job Description

A fantastic opportunity has arisen for an Operations Lead Biotech Associate on the Cell Banking/Cell expansion team at our site in Dunboyne, Co. Meath.

Our facility in Dunboyne is a premier, state-of-the-art facility that enables and advances our best work. By integrating leading-edge technology with a dynamic, activity-based workspace, the facility supports seamless connection and collaboration within and across teams and functions. Our Dunboyne facility provides Biologics Drug Substance manufacturing for Clinical Supply, Registration, and Commercial Launch.

Job Purpose

The Operations Lead Biotech Associate is responsible for supporting end-to-end production operations within the specific Manufacturing IPT. This role involves taking ownership of activities within the assigned suite and unit operation, acting as a delegate for the shift lead when unavailable, and ensuring compliance with good manufacturing practices. The Operations Lead Biotech Associate will lead troubleshooting efforts, support continuous improvement projects, and maintain high standards of safety and GMP compliance.

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

• Support end-to-end production operations within the specific Manufacturing IPT.
• Act as a Unit Op Lead, take ownership of activities within the assigned suite and unit operation, and act as a delegate for the shift lead when unavailable.
• Carry out and support assigned operations, delivering shift standard work through a team-based approach to batch progression.
• Execute manufacturing processes according to established work instructions and Standard Operating Procedures (SOPs).
• Run handover boards and provide key updates to shift leads for handover.
• Act as the escalation point of contact (POC) for troubleshooting, task execution, problem solving, and continuous improvement (CI) projects. Support resolution of issues and delays and escalate unresolved issues to the shift manager or operations lead.
• Document executed activities Right First Time (RFT), ensuring accountability and traceability of production records and compliance with good manufacturing practices.
• Ensure Electronic Batch Record (EBR) and related documentation reviews are completed accurately. Confirm by the end of the shift that all activities are correctly completed, including real-time batch record, SAP Comet, and elogs reviews.
• Author, review, and/or edit procedures and technical documents in accordance with cGMP requirements, including support for electronic batch records, sampling plans, work instructions, and SOPs.
• Coach shift teams on RFT documentation and adherence to Right First-Time principles.
• Maintain and support high standards of safety and Good Manufacturing Practice (GMP) compliance at all times. Identify and challenge opportunities to improve site safety and environmental programs.
• Promote EHS leadership behaviours, engage employees at all levels on EHS issues, and visibly lead safety initiatives, including active involvement in safety forums.
• Promote an environment where everyone speaks up for our culture of safety and looks out for one another.
• Participate in safety walkdowns, internal audits, inspections, risk assessments, GEMBAs, and Go-Sees, and support implementation of agreed actions.
• Support incident investigations and audits, including investigations arising from manufacturing documentation, and ensure improvement actions are implemented.
• Coach and provide oversight on the shop floor to identify potential issues before they arise.
• Lead by example through coaching, mentoring, and our company Production Systems (MPS) skill transfer.
• Provide coaching on CAPAs, change actions, SOP updates, and training module development or revision for the assigned area or unit operation.
• Actively participate in cross-functional manufacturing teams to advance projects, goals, and deliverables.
• Lead approved projects and continuous improvement initiatives aligned with site strategies, and support site functional initiatives to improve compliance and operational efficiency.
• Utilize real-time data analytics to inform decisions on value stream improvement initiatives.
• Work as part of a multi-disciplined and dedicated process team where flexibility and teamwork are essential.
• Maintain a high level of personal expertise and working knowledge of the manufacturing process and process equipment through continuous training and development.
• Support maintenance, engineering, quality, or other colleagues as requested.
• Use proactive recognition tools to recognize the teams and individuals you collaborate with.
• Carry out other duties assigned by the Manager, including acting as a designee for the Operations Manager as required.

What skills you need

• Bachelor’s degree in biotechnology, Chemistry, Biology, Pharmacy, or Process Engineering.
• 5+ years’ experience in the biotech industry, including bulk manufacturing of pharmaceutical or biological components.
• Familiarity with contamination control and batch release requirements.
• Proficiency with Delta V, Pas X, and the use of automation in a manufacturing process.
• Experience with various single-use technologies in a manufacturing environment.
• Competence in troubleshooting and practical problem solving.
• Ability to work independently and within a cross-functional team.

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. So, if you are ready to: Invent solutions to meet unmet healthcare needs, Impact the future by driving one of the world’s leading healthcare companies, and inspire your team to reach their full potential and push the boundaries of science and technology, please apply today.

This is site-based role and is 12/7 extended days (4 days on and 4 days off)

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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. 

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