Lead Tech, Operations

MSD

Dunboyne

On-site

EUR 75,000 - 100,000

Full time

43 hours ago

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Job summary

MSD in Dunboyne, Co. Meath, Ireland, seeks an Operations Lead Biotech Associate to drive end-to-end production on the Cell Banking/Cell expansion team. You will lead unit operations, coordinate handovers, and uphold GMP across the manufacturing IPT.

You will mentor teams, improve safety and process performance, and leverage real-time data to inform value-stream improvements. This role requires strong analytical skills and cross-functional collaboration.

Qualifications

Bachelor's degree in biotechnology, chemistry, biology, pharmacy or process engineering.
5+ years' biotech industry experience, including bulk manufacturing of pharma/biological components.
Familiarity with contamination control and batch release requirements.
Proficiency with DeltaV, PAS-X, and automation in manufacturing.
Experience with single-use technologies in manufacturing.
Strong troubleshooting and problem-solving abilities.
Ability to work independently and across functions.

Responsibilities

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 SOPs.
Run handover boards and provide key updates to shift leads for handover.
Act as escalation point of contact for troubleshooting, task execution, problem solving, and CI projects.
Support resolution of issues and delays and escalates 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 GMP.
Ensure Electronic Batch Record (EBR) and related documentation reviews are completed accurately.
Coach shift teams on RFT documentation and adherence to Right First-Time principles.
Maintain safety and GMP compliance; participate in safety initiatives.
Participate in cross-functional manufacturing teams to advance projects and deliverables.
Lead approved projects and CI initiatives aligned with site strategies.

Skills

Biotech degree

5+ years biotech experience

Contamination control

DeltaV

PAS-X

Automation in manufacturing

Single-use tech

Troubleshooting

Cross-functional teamwork

GMP

Problem solving

Education

Bachelor’s degree in biotechnology/chemistry/biology/pharmacy/process engineering

Tools

DeltaV

PAS-X

Single-use tech

Job description

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.

Responsibilities

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 escalates 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.

Skills Required

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.

Additional required skills