Job Description

As Senior Biotech Associate you will be part of Manufacturing Self Directed work team/ Hub in our new state of the art single use multi-product biotech facility in Dunboyne, County Meath. The organisational structure at the site will be based on self-directed work teams (SDWT) where decisions will be made at the level where the data exists. The Senior Biotech Associate is responsible for all procedures and processes associated with the manufacture of Drug Substance at the company’s Dunboyne manufacturing facility, at the highest standards of Safety, Quality and Compliance.

The Senior Biotech Associate will be responsible for undertaking manufacturing operations involved in the production of biologic drug substance on their designated shift.  Key responsibilities include the execution of an automated recipe using paperless technology to progress the drug substance through inoculation and cell culturing activities, leading to filtration and purification of the product in a state-of-the-art single use technology-based facility. The incumbent will be involved in setting up the single use equipment between runs, carrying out the production process according to world class GMP and EHS principles.

The Senior Biotech Associate will also be involved in driving to optimise and improve the processing activities through use of standard work and lean processing techniques while supporting operations team to consistently deliver on specific Key Performance Indicators (KPIs). At all times this role is focused on delivery to the patient through living the Dunboyne culture including a commitment to safety, focusing on right first time in everything we do and a concentrating on the engagement and development of self and peers. 

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

• Support operations team to consistently deliver on specific Key Performance Indicators (KPIs), e.g. Environmental Health and Safety (EHS) metrics, Production Plan, Overall Equipment Effectiveness (OEE), compliance and team training. Complete COMMIT cards to highlight ways of working within our SDWT’s and Hubs and across our site that support our COMMIT culture.
• Provide immediate feedback to others at any time to reinforce good safety and improvement behaviours and acts.
• Execute commercial manufacturing processes according to established work instructions and Standard Operating Procedures (SOPs).
• Ensures that all assigned task related to manufacturing documentation support is in accordance with good manufacturing practices.
• Routinely talk about any safety issues you are concerned about.
• Work as part of a dedicated process team where flexibility and teamwork are a key requirement.
• Generate SOPs/ Work Instructions (WIs) to ensure compliance with regulatory standards.
• Adhere to Right First-Time principles.
• Provide assistance and/or support maintenance, engineering, quality or other colleagues as requested.
• Escalate issues as appropriate to manager/designee.
• Maintain a high level of personal expertise and working knowledge of all aspects of the manufacturing process and process equipment through continuous training and development.
• Liaise with other groups and individuals to ensure planning of tasks is effective and linked into the manufacturing process plan and site schedule.
• Challenge and identify improvements to the safety and environmental programmes on site.
• Celebrate with use of proactive recognition tools that inspire teams and individuals you collaborate with.
• Take part in shift handovers and tier 1 meetings, raising concerns or issues promptly and providing options for resolutions.
• Act as an ERT during emergency situation if trained.
• Maintain/ support a high standard of safety/ Good Manufacturing Practice (GMP) compliance at all times.
• Determine solutions by referencing relevant past experiences as part of problem-solving activities.
• Get actively involved by participating in inspections, GEMBA’s and Go-See’s.
• Act as a team member on process deviation reviews and Gemba walkdowns.
• Mentor new members of staff in specific plant activities.
• Be prepared to answer auditor questions during site walkdowns.
• Engage in implementing innovative solutions that drive a high-performance organisational culture that accommodates rapid growth and highly dynamic expectations ensuring attainment of site operational and development goals.
• Utilize Lean Six Sigma Tools to support the initiative of continuous improvement (CI) projects to increase agility, flow, throughout and reduce cycle time and inventory. Participate in internal audit programs and risk assessment compliance activity. Ensure incident investigations and audits are fully supported with improvement actions implemented.
• Coach shift teams related to RFT documentation.
• Lead by example through coaching and mentoring on Production systems (MPSs) skill transfer.
• Coach CAPAs, change actions/ SOP updates, training module development/revision related to cell area • Utilise real-time data analytics for making decisions on the value stream improvement initiatives.
• Troubleshoot and resolved issues and delays
• Leads and participates in investigations arising from manufacturing documentation aspects when required.
• Promote EHS leadership behaviours and engages employees at all levels on EHS issues.
• Promote an environment where everyone speaks up for our culture of safety and looks out for one another.
• Confirms that all activities have been correctly completed by the end of shift such as Real-time batch record/ SAP Comet review and elogs review.
• Be a visible leader of safety initiatives and stay actively involved in safety forums.
• Act as a Cell Lead and be responsible for a unit operation. 
• Any other duties as and when assigned by the Manager.

What skills you will need:

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

• Level 7 qualification in a science or engineering discipline, or Level 6 with a minimum of 1-3 years’ experience in a GMP regulated Manufacturing environment.
• Experience of Upstream/ Downstream Processing.
• Experience in a highly regulated pharmaceutical manufacturing environment would be desirable.
• Proven record of accomplishments in a regulated industry. 
• Start-up experience in a large-scale commercial drug substance facility, or similar.
• Understanding of Drug Substance Manufacturing Operations.
• Understanding of GMP requirements in a Biopharmaceutical Facility.
• Excellent communication skills and the ability to work in a cross functional collaborative environment.
• Knowledge of applying Lean Six Sigma and Lean methodologies in a workplace environment.
• Possess a detailed overview of the overall upstream/ downstream process, with expertise and working knowledge of the manufacturing process.
• Maintain a high level of expertise and working knowledge of the process equipment.
• Can lead and deliver cross-functional Operational Excellence projects/ Initiatives.
• A proven ability to work with automated systems such as Manufacturing Execution System (MES), Systems Applications and Products (SAP), Delta V etc.
• Demonstrate success in a team environment in either a project or work-related activities.
• Demonstrate troubleshooting competency.
• Desire to learn and develop.  Ability to interact with multiple stakeholders across numerous departments.
• Excellent communication skills.
• Ability to manage multiple priorities and know when to escalate issues for resolution.
• Excellent trouble shooting skills as well as an ability to coach and mentor self-directed teams through complex problem solving. High degree of problem-solving ability and adherence to scheduled timelines.
• A proven ability to lead cross functional teams and deliver on tight timelines.

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 Ireland to the world.

Our Commitment to Ireland:

We are one of the Ireland’s leading healthcare companies, having first established here over 50 years ago. We have a dynamic and diverse 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 the company’s top products, helping save and enhance lives in over 140 countries around the world.

The latest addition to the Ireland family is Dunboyne which joined our network in September 2020. Our Dunboyne site is the company’s first Biologics Drug Substance Single Use Commercialisation Facility, playing an important role in helping to commercialise key medicines as the newest addition to the company network. The cutting-edge innovation and collaboration between Dunboyne’s research and manufacturing teams will significantly accelerate the time it takes to bring a medicine to market for the benefit of patients around the world.

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.

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.

So, if you are ready to:

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

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):

Required Skills:

Applied Engineering, Applied Engineering, Automated Manufacturing Systems, Cell Cultures, Downstream Processing, Equipment Maintenance, GMP Compliance, Good Manufacturing Practices (GMP), Key Performance Indicators (KPI), Lean Enterprise, Lean Management, Lean Six Sigma (LSS), Maintenance Processes, Mammalian Cell Culture, Management Process, Manufacturing, Manufacturing Environments, Manufacturing Processes, Microbiology, Operational Excellence, Operations Support, Organizational Performance Management, Pharmaceutical Manufacturing, Pharmaceutical Microbiology, Production Processes {+ 4 more}

 Preferred Skills:

Job Posting End Date:

05/17/2025

*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.