Lead Manufacturing Biotech Associate

Job Description

An amazing opportunity has arisen for a Lead Biotech Associate at our Dunboyne site.

Reporting to the Manufacturing Shift Manager, Operations, you will be part of the Manufacturing Self Directed work team/ Hub in our state-of-the-art single use multi-product biotech facility in Dunboyne, County Meath.

As a Lead Manufacturing Biotech Associate, you will have strong interpersonal, communication, and collaboration skills. The Lead Manufacturing Biotech Associate is responsible for supporting the manufacturing process, while creating an inclusive culture that energizes a Safety First, Quality Always, with a continuous improvement mindset.

What you will do:

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

• Carry out and support operations to achieve assigned duties.
• Deliver shift standard work for a team-based approach to batch progression.
• Complete COMMIT cards to highlight ways of working within our SDWT’s and Hubs and across our site that support our COMMIT culture.
• Conduct sampling/ in-process testing supporting the manufacturing and validation processes.
• Document executed activities necessary to allow proper accountability and traceability of production records, Right First Time (RFT).
• Author, review, and/or edit procedures and technical documents to ensure the documents are in accordance 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 is in accordance with good manufacturing practices
• Initiate/ maintain housekeeping in all work areas.
• Identify, escalate and address compliance, environmental, safety, and process deviations as appropriate.
• Support execution of safety walkdowns, audits/ inspections, risk assessment, implementation of agreed upon actions, etc.
• Ensure incident investigations are fully supported with improvement actions implemented and participate in investigations arising from manufacturing documentation aspects as and when required.
• Coach and provide oversight on the shop floor to identify potential issues before they arise.
• Actively participate on cross-functional manufacturing teams to advance projects, goals and deliverables.
• Lead approved projects and continuous improvement initiatives that are in alignment with the site strategies.
• Lead straight-through document accuracy metrics and the development of a CI framework.
• Support site functional initiatives to improve compliance status and operational efficiency of the site.
• Run handover boards and provide key updates to shift leads for handover.
• Be escalation point of contact (POC) for troubleshooting, supporting task execution, problem solving, CI projects and assist with the resolution of issues/ delays.
• Take ownership of activities within a suite and act as a delegate for the shift lead if they are unavailable.
• Ensure process equipment is maintained including preventative maintenance, equipment troubleshooting and repairs to ensure continuous, reliable and repeatable operation of equipment.
• Effectively manage and schedule equipment shutdowns.
• Ensure resources are available, thereby minimizing downtime.

This is a site-based position, working shift on a 24/7 basis.

In order to excel in this role, you will more than likely have:

• Bachelor’s Level 8 degree in Science, Engineering or other Technical Discipline/ or relevant experience.
• 5 years’ experience in Biopharma industry, with direct experience of biologics manufacture with a minimum of 2 years in Downstream.
• Proficiency with automated systems such as Manufacturing Execution System (MES - PAS X), Systems Applications and Products (SAP), Delta V etc.
• Knowledge of Lean methodologies.
• Familiar with all Safety, GMP, Environmental and Validation permits, policies and procedures.
• Willingness to training others and/ or leading hands-on or instructor-led training.
• Ability to read, write and understand technical information.

As a company, we are committed to 'Inventing for Life' in all that we do. 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.

So, if you are ready to:

Invent solutions to meet unmet healthcare needs, please apply today.

Required Skills:

Accountability, Accountability, Adaptability, Applied Engineering, Autoclaving, Biological Manufacturing, Cell Culture Process Development, Collaborative Communications, Continual Improvement Process, Data Analysis, Filtering Equipment, GMP Compliance, Good Laboratory Practices (GLPs), Good Manufacturing Practices (GMP), Incident Investigations, Instructor-Led Training (ILT), Lean Management, Liquid Chromatography (LC), Management Process, Manufacturing, Manufacturing Documentation, Manufacturing Processes, Manufacturing Quality Control, Media Preparation, Operational Efficiency {+ 3 more}

Preferred Skills:

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:

Not Applicable

Shift:

Valid Driving License:

Hazardous Material(s):

Job Posting End Date:

11/22/2025

*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.