Bioprocess Associate - Drug Substance

Msd Ireland; Leinster; On-site; EUR 45,000 - 65,000; Full time

Job summary

MSD Ireland in Dundalk is seeking a Bioprocess Associate (Drug Substance) to join our fast-growing facility, working with cutting-edge technology to deliver medicines to patients. You will operate DS/USP/DSP processes, maintain cGMP and safety standards, write and review SOPs and batch records, train colleagues, and support KPI delivery including safety, quality and OEE.

The role requires 1 year+ regulated environment experience and offers a day shift with potential future rotation.

Qualifications

• Certificate, Diploma, Degree, or equivalent in a regulated GMP environment.
• Knowledge of cGMP, safety and environmental regulations in biopharma.
• Experience recording information in real-time using electronic or manual systems.
• Experience executing operations following SOPs and batch records.

Responsibilities

• Manufacture drug substance through inoculation, cell expansion, and bioreactor activities, including filtration and purification.
• Set up single-use equipment between runs and perform production per GMP/EHS principles.
• Carry out DS Downstream Processing (DSP) and Upstream Processing (USP) activities, plus buffer/media prep.
• Perform operations in assigned area per SOPs and Manufacturing Batch Records.
• Maintain a safety-oriented, cGMP-compliant work environment at all times.
• Write, review, and revise SOPs, OJTs, PBRs, logbooks, and work instructions.
• Train and mentor colleagues in SOPs and equipment operation.

Skills

Analytical Problem Solving

Biological Manufacturing

Cleanroom Gowning

Computer Literacy

GMP Operations

Manufacturing Quality Control

SOPs

Upstream Processing

Vaccine Production

Education

Degree/Certificate in relevant field

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 labs that 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.

So, If You Are Ready To

Invent solutions to meet unmet healthcare needs,

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