Senior Specialist, MS&T (Upstream or Downstream)

MSD Malaysia; Dublin; Hybrid; EUR 70,000 - 110,000; Full time

Benefits offered by this job

Hybrid working model

Flexible working

Job summary

Senior Specialist in Manufacturing Science and Technology is sought for our Dublin biotech facility. You will provide technical support to our drug substance operations, lead investigations, and assist with technology transfer and qualification activities across manufacturing equipment and processes.

Applicants should have at least 5 years of technical operations experience in commercial-scale biologics production, with knowledge of upstream and/or downstream processing, process control, and

Qualifications

• 5+ years of technical operations experience in commercial-scale drug substance manufacturing of biological molecules.
• Degree in Pharmaceutical, Biological or Chemical Engineering or Sciences or related discipline.
• Strong knowledge of upstream or downstream purification processes and process control strategies.
• Experience with regulatory standards, data systems, and automation in a regulated environment.
• Proven track record in leading technical projects and cross-functional collaboration.

Responsibilities

• Lead Technical Investigations: drive root cause analyses and CAPA activities.
• Drive Process Optimisation using SPC and data analysis to improve yield and robustness.
• Support Technology Transfer & Projects including qualification batches and supplier materials.
• Manage Qualification Documentation: write and execute qualification protocols and reports for equipment and processes.
• Foster Cross-Functional Collaboration with operations, quality and regulatory partners.
• Uphold Safety & Compliance with cGMP and regulatory audits.

Skills

Process Engineering

Root Cause Analysis

Collaboration

Lean Six Sigma

Upstream Processing

Education

Degree in Pharmaceutical, Biological or Chemical Engineering or Sciences

Job description

Job Description

Are you passionate about biotechnology and eager to make a meaningful impact on patients' lives? We are looking for a Senior Specialist in Manufacturing Science and Technology to join our Process Engineering team at our biotechnology facility in Dublin. Whether your expertise lies in upstream cell culture or downstream purification, we welcome your unique perspective. In this role, you will provide vital technical support to our drug substance business. You will lead technical investigations, support major site projects, and help design, qualify, and transfer technology for manufacturing equipment. You will play a key role in ensuring we safely and reliably supply high-quality products, while fostering an inclusive, collaborative environment focused on continuous improvement. Bring energy, knowledge, innovation to carry out the following:

• Lead Technical Investigations: Guide multidisciplinary teams to find the root causes of process deviations. You will lead root cause analyses, implement effective Corrective and Preventive Actions, and author product impact assessments to support safe batch releases.
• Drive Process Optimisation: Monitor and analyse commercial manufacturing trends using statistical process control and data analysis. You will use these insights to identify opportunities that improve process yield, reliability and robustness.
• Support Technology Transfer & Projects: Play a key role in introducing new products to the site. You will support the execution of development and Process Performance Qualification batches, manage change controls and assist with qualifying materials from suppliers.
• Manage Qualification Documentation: Design, write, review and execute qualification protocols and reports for manufacturing equipment and processes, ensuring everything aligns with standard site practices.
• Foster Cross-Functional Collaboration: Lead and collaborate with diverse teams—including operations, quality and regulatory partners—using continuous improvement methodologies (such as Lean Six Sigma) to troubleshoot and streamline operations.
• Uphold Safety & Compliance: Maintain a strong "Safety First, Quality Always" mindset. You will ensure all activities comply with global policies, regulatory standards and current Good Manufacturing Practices, while actively participating in internal and external regulatory audits.

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

• Experience: At least 5 years of technical operations experience in commercial-scale drug substance manufacturing of biological molecules, including hands-on experience with upstream cell culture and/or downstream purification.
• Education: A degree in Pharmaceutical, Biological or Chemical Engineering or Sciences, or a related discipline.
• Technical Expertise: Strong knowledge of upstream or downstream purification processes, process control strategies, and regulatory standards. Experience with process monitoring, automation systems, and data systems in a regulated environment is highly valued.
• Leadership & Collaboration: A proven track record of leading technical projects, managing change, and solving complex problems. You are an encouraging teammate who enjoys coaching others, sharing knowledge, and building inclusive relationships.
• Communication: Excellent technical writing skills and the ability to explain complex biological processes clearly to diverse teams.

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.

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.

Required Skills:

• Change Management
• Collaboration
• Continuous Improvement
• Current Good Manufacturing Practice (cGMP)
• Downstream Processing
• Leadership
• New Product Introduction (NPI)
• Regulatory Compliance
• Root Cause Analysis (RCA)
• Technical Investigation
• Technology Transfer
• Upstream Processing

Preferred Skills:

Employee Status: Regular Relocation: VISA Sponsorship: Travel Requirements: Flexible Work Arrangements: Hybrid Shift: Valid Driving License: Hazardous Material(s):

Job Posting End Date: 09/5/2026

Our company is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where we have codified our legacy for over a century. Our success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.