Associate Director, Bioprocess & Technical Engineering

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. Bring energy, knowledge, innovation to carry out the following: Strategic Technical Leadership and Facility IntegrationGuide 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 CommercialisationServe 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 ImprovementLead 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 BuildingFoster 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: In order to excel in this role, you will more than likely have: 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. 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. 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 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 a