Bioprocess Associate - Drug Substance

Merck; Leinster; On-site; EUR 36,000 - 48,000; Full time

Job summary

Merck Ireland is seeking a Bioprocess Associate (Drug Substance) at Dundalk to join a fast-growing site focused on patient outcomes and safety. You will work within a cutting-edge, single-use facility and contribute to cGMP-compliant operations across DS/USP/DSP processes.

The role involves SOPs, PBRs, logbooks, OJT, and training, with a shift pattern transitioning to 4 cycle 12/7. A strong GMP background and biopharma experience are essential for success.

Qualifications

• 12+ months in a regulated GMP environment.
• Knowledge of cGMP, safety and environmental regulations in biopharma.
• Experience recording information in real-time (electronic or manual).
• Experience executing operations following SOPs, Batch Records, and Manufacturing Controls Systems.
• Experience in the biopharmaceutical industry.
• Experience working in Grade C, D and CNC environments.

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 preparation.
• Carry out production operations per SOPs and Manufacturing Batch Records (MBRs).
• Write, review, and revise SOPs, OJT's, PBRs, logbooks and training materials.
• Train and mentor colleagues in SOPs, process execution and equipment operation.
• Support KPI delivery: Safety, Quality, Schedule adherence, OEE, and training.
• Lead shift handovers and liaise with Shift Lead on production challenges.

Skills

cGMP knowledge

Regulatory compliance

Real-time data capture

SOPs & MBRs

Biopharmaceutical experience

Grade C/D/CNC cleanroom

Education

GMP training or degree

12+ months 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 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