Associate Director, Bioprocess & Technical Engineering

Merck Gruppe - MSD Sharp & Dohme; Dublin; Hybrid; EUR 180,000 - 240,000; Full time

Job summary

Merck Gruppe - MSD Sharp & Dohme is seeking an Associate Director for Bioprocess & Technical Engineering to lead strategic technical initiatives at the Dublin Biotech site and across the external manufacturing network. The role focuses on facility-fit, process engineering, and robust technology transfers across complex biologics processes.

You will shape engineering roadmaps, guide design choices, and partner with Manufacturing Science, External Manufacturing, Quality, Regulatory, and Automation

Qualifications

• Bachelor's degree in engineering, biological sciences, chemistry, biotechnology, or closely related discipline.
• 10 years of relevant professional experience across engineering, manufacturing operations, process development or technology transfer.
• Minimum of 5 years direct experience in biologics drug substance manufacturing with process engineering, facility design, or tech transfers.
• Deep technical knowledge of bioprocess engineering unit operations: cell culture, purification, mass balance, fluid dynamics, scale-up, automation, design-to-shop-floor link.
• GMP environments experience, change control, quality risk management, and health authority expectations.
• Strong investigative capability with structured RCA, risk mitigation, and CAPA design.
• Excellent communication to shop-floor technicians, peers, and executives.

Responsibilities

• Provide strategic leadership for facility integration and technical standards across the Dublin site and external partners.
• Lead technology transfer for biologics drug substance processes and lifecycle management across networks.
• Coordinate cross-functional teams to establish shared engineering standards and robust transfer pathways.
• Conduct complex investigations for process variations and drive CAPAs with cross-site collaboration.
• Support regulatory and quality teams to ensure compliant, safe, and efficient operations.

Skills

Process Engineering

Bioprocess Engineering

Technology Transfer

Manufacturing Scale-Up

Regulatory Compliance

Root Cause Analysis

Investigation Management

Stakeholder Management

Strategic Thinking

Data Analysis

Influencing Skills

Education

Bachelor's degree in engineering or biological sciences

Job description

Job Description

Join our Large Molecule Technical Operations Unit as an Associate Director, Bioprocess & Technical Engineering.

This is a strategic technical leadership role within the Biologics Drug Substance network, focused on strengthening process capability, enabling robust technology transfers and advancing facility-fit, process engineering and technical readiness across internal sites and external partners. The role offers the opportunity to shape how complex biologics processes are introduced, scaled, optimised and sustained across the network, while contributing to high-impact initiatives that directly support product supply, quality and patient access.

Our team is committed to technical excellence, scientific rigor, collaboration and accountability. We partner across Manufacturing, Science & Technology, External Manufacturing, Quality, Regulatory, Procurement, Automation and Engineering to ensure that drug substance processes are transferred and operated with the right level of technical depth, engineering discipline, and business focus.

In this role, you will serve as a key technical leader within the Bioprocess & Technical Engineering team, reporting to the Director of Bioprocess & Technical Engineering. The role will have primary responsibilities at our Dublin Biotech site and across the wider Drug Substance external manufacturing network as needed, with a focus on establishing strong technical standards, enabling right-first-time execution and building scalable process engineering capability across the network.

• Strategic Technical Leadership and Facility Integration
  • Guide comprehensive facility-fit evaluations for our Dublin site and external manufacturing partners, ensuring that mass balance calculations, equipment capabilities, automation interfaces, and clean utility boundaries align seamlessly with process requirements.
  • Translate emerging industry trends, platform technologies, and future pipeline needs into clear, practical engineering roadmaps that prepare our facilities for next-generation biological therapies.
  • Evaluate proposed manufacturing configurations thoughtfully, examining assumptions constructively to ensure that engineering decisions are grounded in sound scientific rationale.
• Robust Technology Transfer and Process Commercialisation
  • Serve as the technical lead for commercialising biological drug substance processes, embedding sound process engineering principles into initial design, process validation, and long-term lifecycle management.
  • Provide clear, actionable guidance on process capability, equipment selection, and capacity utilisation to ensure reliable manufacturing execution and prevent supply disruptions.
  • Participate in technical due diligence assessments for prospective external partners, new processing platforms, and collaborative manufacturing ventures, helping our organisation make well-informed, risk-balanced decisions.
• Collaborative Problem-Solving and Continuous Improvement
  • Lead and coordinate complex investigations when unexpected process variations occur, bringing structured root-cause analysis, calm technical judgement, and supportive cross-site collaboration to establish lasting Corrective and Preventive Actions.
  • Partner with colleagues across Manufacturing Science and Technology, External Manufacturing Operations, Quality Assurance, Regulatory Affairs, Automation, and Procurement to establish shared engineering standards that make future transfers simpler, faster, and more dependable.
  • Work alongside regulatory and quality teams to interpret compliance standards sensibly, uncovering pragmatic, science-based approaches that uphold the highest levels of safety whilst improving operational flow.
• People, Culture, and Capability Building
  • Foster a welcoming, psychologically safe working environment where team members feel encouraged to ask questions, share differing perspectives, and learn collectively from challenges.
  • Mentor early-career engineers and scientists, generously sharing your knowledge to nurture a community that values curiosity, scientific rigour, and mutual support.

What skills you will need

• A Bachelor of Science or Bachelor of Engineering degree in engineering, biological sciences, chemistry, biotechnology, or a closely related discipline.
• 10 years of relevant professional experience across engineering, manufacturing operations, process development, or technology transfer.
• A minimum of 5 years of direct experience in biologics drug substance manufacturing, showing proven capability in process engineering, facility design, commercial manufacturing support, or technical transfers.
• Deep technical knowledge of bioprocess engineering unit operations, including cell culture, purification, mass balance modelling, fluid dynamics, scale-up principles, equipment automation, and the practical link between process design and shop-floor execution.
• Proven experience working within Good Manufacturing Practice environments, including familiarity with formal change control procedures, quality risk management frameworks, and health authority expectations.
• Strong investigative capability, with proven skill in applying structured root-cause analysis, risk mitigation strategies, and the design of effective Corrective and Preventive Actions.
• Exceptional communication skills, with an ability to articulate complex technical ideas clearly, warmly, and persuasively to shop-floor technicians, multi-disciplinary peers, and executive leaders alike.
• Preferred experience:
  • Practical experience working with monoclonal antibody drug substance manufacturing across upstream or downstream operations.
  • Hands-on involvement in Process Performance Qualification campaigns, new product introductions, or post-approval lifecycle changes across internal and contract manufacturing networks.
  • Familiarity with structured continuous improvement frameworks, such as Lean manufacturing principles, standard work practices, and Six Sigma problem-solving approaches.
  • Experience supporting health authority inspections, preparing technical filing sections, or resolving regulatory inquiries across international markets.
• Travel may be a requirement of this position up to 20%.

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.

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.

Required Skills

• Clinical Manufacturing
• Commercialization
• Data Analysis
• Influencing Skills
• Investigation Management
• Manufacturing Scale-Up
• Process Engineering
• Regulatory Compliance
• Root Cause Analysis (RCA)
• Stakeholder Management
• Strategic Thinking

Employee Status: Regular

Flexible Work Arrangements: Hybrid

Job Posting End Date:09/29/2026

*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:R416838