Job Description

An opportunity has arisen for the position of Senior Manufacturing Biotech Associate at our single-use Dunboyne facility.

As Senior Biotech Associate you will be part of a self-directed work team in Downstream Operations, responsible for all procedures and processes associated with the manufacture of Drug Substance. The Senior Manufacturing Biotech Associate leads by example by always upholding the highest standards of Safety, Quality, GMP, Right First Time and Compliance.

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 single use technology-based facility.

The Senior Biotech Associate will also be involved in optimising and improving processing activities through use of standard work and lean processing techniques, while consistently delivering on specific KPI’s. This role is focused on delivery to the patient through living the Dunboyne culture, including a commitment to safety, right first time in everything we do, and a focus on the engagement and development of self and peers.

What you will do:

Bring your energy, knowledge, and innovation to:

• As a senior team member, be strong technically, with an excellent grasp of processes and procedures. Already an SME on many processes, be strongly motivated to acquire knowledge and understand all Downstream processes to a micro level
• Proactively train, coach and mentor less experienced team members, by being approachable, supportive, inclusive and generous with knowledge, while striving to work in a cohesive and proactive team, with a ‘never let a teammate fail’ mindset
• Display flexibility, adaptability, innovation, with a reflexive ability to think on your feet, also possess a strong skill set for logical root cause analysis, and problem solving
• Be an excellent communicator, and true team player with concern for others. Be able to deliver business unit goals through strong and cohesive collaboration with other departments, within a matrix reporting environment
• Display high initiative and be ready to take responsibility; thinks ahead, seeks the production schedule daily, and lays plans to achieve or exceed it
• Takes part in shift handovers and Tier meetings, raising concerns or issues promptly and providing options for resolutions.
• Be actively involved by participating in inspections, GEMBA’s and Go-See’s, OPPS, improvement projects and other MPS initiatives
• Perform EBR and documentation reviews, raising triage cards and any other documentation or administrative tasks as directed by your manager
• Utilise Lean Six Sigma Tools to support the initiative of continuous improvement (CI)
• Be proficient to SME level with production systems such as MES, DeltaV, SAP, GLIMS, PROCAL and others
• Deputises when required, to represent the department at meetings and discussions, and performs any other duties as appropriate when assigned by the Manager

What skills you will need:

To excel in this role, you will more than likely have:

• A Level 7, or higher, qualification in a science or engineering discipline, with a minimum of 3 years’ experience in a GMP regulated Manufacturing environment.
• Strong experience in a highly regulated pharmaceutical manufacturing environment
• Excellent communication skills and the ability to work in a cross functional collaborative team
• Willingness and ability to work 24/7 shift operations, which include days, nights and weekend work in rotation
• Possess a detailed overview of the overall Upstream and Downstream processes, with expertise and working knowledge of the manufacturing process
• Maintain a high level of expertise and working knowledge of the process equipment.
• A proven ability to work with automated systems such as Manufacturing Execution System (MES), Systems Applications and Products (SAP), Delta V etc.
• Strong knowledge and understanding of manufacturing GMP and quality systems
• Demonstrate troubleshooting and problem-solving competency
• Desire to learn and develop. Ability to interact with multiple stakeholders across numerous departments
• Knowledge and experience of Kanban, JIT, 5S and Lean Manufacturing methodologies
• 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 deliver on tight timelines

This position will support the manufacturing shift team to deliver batch operations successfully,

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.

We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment.

So, if you are ready to:

Invent solutions to meet unmet healthcare needs, Impact the future by driving one of the world’s leading healthcare companies, and inspire your team to reach their full potential and push the boundaries of science and technology, please apply today.

Required Skills:

Accountability, Accountability, Biopharmaceutical Manufacturing, Business Administration, Business Information Systems, Business Systems, Cell Cultures, CNC Operations, Computer Literacy, Data Analysis, FDA Regulations, GMP Compliance, Good Manufacturing Practices (GMP), Incident Investigations, Laboratory Techniques, Manufacturing Documentation, Manufacturing Quality Control, Master Batch Records, Material Selection, Operations Management, Pharmaceutical Process Development, Production Planning, Production Processes, Regulatory Compliance, Risk Assessments {+ 5 more}

Preferred Skills:

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):

Job Posting End Date:

01/9/2026

*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.