Bioprocess Associate - Drug Substance

Merck Gruppe - MSD Sharp & Dohme; Leinster; Hybrid; EUR 47,000 - 65,000; Full time

Benefits offered by this job

Hybrid working model

Job summary

Merck Group - MSD Sharp & Dohme in Ireland seeks a Bioprocess Associate (Drug Substance) at our Dundalk facility, to manufacture drug substance using DS DSP/USP in a state-of-the-art single-use facility.

You will work with GMP and EHS standards, lead SOPs and training, support KPI delivery, and participate in shift handovers; the role is currently days with a transition to 4 cycle 12/7, and offers hybrid working where possible.

Qualifications

• 12+ months in a regulated GMP environment.
• Knowledge of cGMP, safety and environmental regulations in biopharmaceuticals.
• Experience recording information in real-time (electronic or manual).
• Experience executing operations following SOPs, Batch Records and Manufacturing Controls.

Responsibilities

• Manufacture drug substance through inoculation, cell expansion, and bioreactor activities.
• Set up single-use equipment between runs and perform production per GMP and EHS principles.
• Carry out DS Downstream Processing (DSP), Upstream Processing (USP) and buffer/media prep.
• Follow SOPs, Batch Records, and Manufacturing Controls Systems in all operations.
• Assist in maintaining a safety-oriented, cGMP-compliant environment.
• Write, review, and revise SOPs, OJT, PBRs, logbooks and Work Instructions.
• Train and mentor colleagues in SOPs and equipment operation.
• Support KPIs: safety, quality, schedule adherence, OEE, and team training.
• Assist investigations and deviations via Quality System and engage relevant stakeholders.
• Lead and participate in shift handovers and liaise with Shift Lead on issues.
• Apply Lean tools (5S, TPM, Gemba) to improve efficiency and CI culture.
• Provide cross-functional support to maintenance, engineering, quality as needed.
• Operate in accordance with company policies & SOPs and global regulatory guidelines.
• Support development, commissioning and qualification of new vaccine drug substance manufacturing equipment.

Skills

Analytical Problem Solving

Biological Manufacturing

Cleanroom Gowning

Computer Literacy

GMP Operations

Good Manufacturing Practices (GMP)

Manufacturing Quality Control

Standard Operating Procedure (SOP)

Upstream Processing

Vaccine Production

Education

Regulated GMP environment experience

Job description

Job Description

An exciting opportunity a Bioprocess Associate (Drug Substance) has arisen at our Dundalk manufacturing facility, you will be a key member of our fast-growing, dynamic startup, working with cutting-edge technology.

This role is focused on delivering to the patient through living the Dundalk culture, including a commitment to safety, focusing on right first time in everything we do, and concentrating on the engagement and development of self and peers.

The role is currently on Days but will transition to 4 cycle 12/7.

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

• Manufacture drug substance through inoculation, cell expansion, and bioreactor activities, leading to filtration and purification of the product in a state-of-the-art single-use technology-based facility.
• Set up single-use equipment between runs and carry out the production process according to world-class GMP and EHS principles.
• Perform manufacturing processes including DS Downstream Processing (DSP), Upstream Processing (USP), and Buffer/Media preparation.
• Carry out all production operations in the assigned area as per the relevant SOPs and Manufacturing Batch Records.
• Assist in maintaining a safety-oriented, cGMP-compliant work environment at all times.
• Write, review, and revise area Standard Operating Procedures (SOPs), On the Job Training (OJT’s), Production Batch Records (PBRs), Logbooks, Training Competencies, and Work Instructions.
• Train and mentor colleagues in SOPs, process execution, and equipment operation.
• Support the Manufacturing team to consistently deliver on specific area Key Performance Indicators (KPIs), e.g., Safety, Quality, Schedule adherence, Overall Equipment Effectiveness (OEE), and team training.
• Assist with the investigation of and operations deviations through the Quality System, engaging with all relevant personnel and functions as appropriate.
• Lead and actively participate in shift handovers.
• Liaise with the Shift Lead regarding issues that may arise within the production area, including highlighting operational challenges.
• Use Lean Tools as part of daily operations (Standard Work, 5S, TPM, Gemba, Method 1, our company Production System (MPS)) to optimize efficiency and drive the culture of Continuous Improvement (CI).
• Provide assistance and/or support maintenance, engineering, quality, or other colleagues as requested.
• Conduct all activities in accordance with Company policies & SOPs & global regulatory guidelines (including cGMP/cGLP/cGCP), environmental guidelines, as appropriate.
• Support the development, commissioning & qualification of new vaccines drug substance manufacturing equipment and subsequent transition to commercial manufacturing.

What skills you will need:

• Certificate, Diploma, Degree, Trade qualification, or equivalent demonstrated experience of 12 months or more in a regulated environment, GMP environment.
• Knowledge and experience of relevant cGMP, safety, and environmental regulations within the biopharmaceutical industry.
• Experience with recording information in real-time using electronic or manual systems.
• Experience in executing operations while following SOPs, Batch Records, and Manufacturing Controls Systems.
• Experience in the biopharmaceutical industry.
• Experience of working in Grade C, D, and CNC environments.

Ireland – The Company:

Within our Company in Ireland, we work at the forefront of science and technology to advance manufacturing excellence and R&D across our Irish sites and global company network. We’re always looking to make a difference for people, patients, and communities – from our Company in Ireland to the world.

Our Commitment to Ireland:

Ireland is one of the Ireland’s leading healthcare companies, having first established here over 50 years ago. We have a dynamic and team of over 3,000 employees currently working across seven sites in Ballydine, Co Tipperary, Brinny, Co Cork, Dunboyne, Co Meath, Carlow, and Dublin, where, in addition, operate substantial Human Health and Animal Health businesses. Through our long-standing footprint in Ireland and over $6 billion invested across our Irish operations, our Irish sites manufacture many of our Company’s top products, helping save and enhance lives in over 140 countries around the world.

As a cutting-edge, state-of-the-art vaccines facility spanning over 15,500 square metres across three stories, our Dundalk site will focus on qualification, continued product development and expanding its capabilities within our network.Featuring drug substance manufacturing, drug product manufacturing and quality control labsthat will support the global supply of vaccine products - strengthening our ability to make an impact on people and patients worldwide by adding new capabilities to our already industry-leading network

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 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.

Required Skills:

• Analytical Problem Solving
• Biological Manufacturing
• Cleanroom Gowning
• Computer Literacy
• GMP Operations
• Good Manufacturing Practices (GMP)
• Manufacturing Quality Control
• Standard Operating Procedure (SOP)
• Upstream Processing
• Vaccine Production

Preferred Skills:

• Lean Manufacturing
• Team Training

Employee Status:

Regular

Relocation:

No relocation

VISA Sponsorship:

No

Travel Requirements:

No Travel Required

Flexible Work Arrangements:

Not Applicable

Shift:

1st - Day

Valid Driving License:

No

Hazardous Material(s):

NA

Job Posting End Date:

09/30/2026

*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.

Requisition ID:

R414146