Job Description A fantastic and hugely exciting opportunity has arisen for an Operations Executive Director for Biologics clinical and commercial manufacturing at our single-use, multi-product commercialization facility in Dunboyne. Reporting to the Site Lead, this position will drive transformational change for capacity realization and operational excellence to deliver all components of stable manufacturing teams and processes for a diverse and complex Biologics pipeline. This is a new position to establish single accountability across all manufacturing Operations at the site and to drive standardization and simplified ways of workings for optimal utilization and resource agility. This position will provide leadership and operations support on Biologics drug substance (DS) and cell banking manufacturing and release in addition to technology transfer, PPQ, inspection readiness and approval of new products. This position will include leadership across five facilities and 300 personnel within the organization, including days and shift teams. Responsibilities Responsible for all Manufacturing Operations within four state of the art multi-product facilities used for clinical and commercial manufacture of Biologics Drug Substance, a Cell Banking facility and associated Weigh/Dispense and Solution Prep activities. Plans and directs all aspects of production activities associated with manufacturing or technology transfer and ensures that all projects, initiatives and processes are in conformance with established policies, standards and objectives. Serves on the Site Leadership Team for Operations to develop and deliver toward site and organizational priorities and strategy. Ensure right-first-time and stable start-up, including through technology transfer leadership, execution of clinical, PPQ and commercial batches, change management and implementation of process improvements. Drive a strong compliance mindset within the organisation, including proactive safety and quality culture, and adherence to all regulatory expectations. Ownership for ensuring permanent inspection readiness is in place. Ensure production and project milestones are achieved through planning and execution of integrated overall program schedule Establish and deliver on KPI's in a timely manner, including schedule adherence, training, hiring, uptime, change controls, investigations, CAPAs, capital/expense targets, sustainability targets, yield/volume/cadence/operational availability, Right First Time, and timely documentation closure. Drive standardization, execution and operational excellence by applying Lean principles to foster continuous improvement mindset to deliver a productive and cost-efficient operating model. Manage and develop operations team personnel toward strong, empowered leaders. Build, inspire, reward and develop diverse talent with the capabilities necessary to succeed in manufacture. Develop facility and resource capacity model across all Operations on site. Resolve resource and prioritisation constraints and support resource needs and changes. Drive a strong technical and digital mindset within the department, staying up to date with emerging technologies that will benefit the organization and manufacturing processes. Resolve issues and identify risks in a timely fashion to the relevant on-site and above-site stakeholders. Responsible for prioritisation of proposed risk mitigation plans and/or acceptance of Quality Risks identified as part of the Quality Risk Management Process. Provide clear direction and definition of any new project scope, goals and deliverables, to the site and cross-functional sub-teams on an on-going basis Resolve issues and identify risks in a timely fashion to the relevant on-site and above-site Stakeholders. Manage financial forecasts and workload to achieve departmental headcount and cost improvements General competencies Strong leadership and interpersonal skills, including leading and coaching direct team to drive a high performance organizational culture that accommodates rapid growth & highly dynamic operating execution. Inspirational leader that leverages data to set the vision and drive outcomes. The desire to continuously learn, improve and grow, and cultivate continued development within the team Innovative thinker, with excellent decision-making and problem-solving skills. Ability to participate in and lead highly effective cross functional teams, build diverse talent, with a passion to build the future of the Dunboyne facility. Ability to influence across organizational layers, as well as outside the site and externally with partners and based on industry benchmarking. Ability to rapidly understand complex business & technical issues including multi-option scenarios to mitigate risk and ensure continuity of supply as well as strategic initiatives. A great communicator, decisive decision maker with a proven ability to deliver excellence. Technical competencies Proven capabilities in site manufacturing and technical operations, experience of Operational Excellence, Six Sigma and Lean Methodologies and a proven track‑record in project management. Proven capabilities and knowledge of Biologics Drug Substance manufacturing, particularly in downstream processes Set clear performance standards; overcome obstacles; hold ourselves and others accountable for achieving results. Knowledge of global and company health authority regulations and applicable systems & GMP requirements. Experience engaging with regulatory agencies including in on‑site inspections Sound judgment and comfortable operating in a challenging, fast‑paced and sometimes ambiguous environment. Minimum Education/Experience Degree qualification or equivalent (Science, Engineering, Technical or other relevant studies). Demonstrated leadership with at least 15 years leading in a cross‑functional manufacturing environment, including indirect or direct people management experience Demonstrated Biologics manufacturing and technology transfer experience Required Skills Accountability, Change Agility, Consulting, Cross‑Cultural Awareness, Data‑Driven Decision Making, Decision Making, Driving Continuous Improvement, Equipment Set Up, Fabrication Processes, GMP Compliance, Leadership, Lean Design, Lean Management, Management Process, Manufacturing Processes, Manufacturing Quality Control, Operational Excellence, Organizational Culture, People Leadership, Production Scheduling, Project Management, Raw Material Specifications, Regulatory Compliance, Science {+ 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 04/3/2026 *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. #J-18808-Ljbffr
A leading biopharmaceutical company in Leinster seeks an Executive Director of MS&T to provide senior technical leadership for their complex biologics manufacturing campus. This pivotal role involves defining technical vision, ensuring compliance in manufacturing processes, and leading investigations to resolve complex technical issues. Candidates should possess extensive experience in biopharmaceuticals and a strong background in leading technical operations, with excellent stakeholder management abilities. A competitive compensation package and future career growth opportunities are offered. #J-18808-Ljbffr
Job Description Under the direction of the Network Strategy & Execution Director, the Associate Director is responsible for assessing, leading and managing the successful "end to end"(E2E) project management of major and complex supply chain changes by driving cross-divisional and cross-functional teams to ensure delivery of the targeted goals and timelines. The Associate Director will effectively and efficiently achieve project objectives and defined business requirements through exceptional project management. The incumbent will lead cross-functional teams for projects that may include establishing new sources of supply for registered materials or managing a portfolio of complex process changes with regulatory impact. Responsibilities Business Case Development Understanding the requirements of a complex business case for assigned changes Continually assessing key business elements across project life cycle to ensure business goals remain relevant in an ever-changing business environment and elevate as required Project | Portfolio Management Owning and developing detailed project plans for given changes using standard tools and ensures the alignment and coordination of cross-functional groups Managing multiple projects at any one time that have high complexity (global supply chain impact with many inter dependencies) Leading and executing within multifaceted project environments with a small to large cross-functional team Strategic Inventory Management | Supply Transitioning Defining key business requirements (validation, regulatory filing, inventory builds, and creating inventory transition plans to the new source of supply or for post-change supply) Risk Management Proactively identifying and mitigating risks and participating in Integrated Risk Management (IRM) Identifying and raising issues and conflicting agendas/priorities for quick resolution Being able to align teams to solve problems Bringing innovation into everyday thinking to mitigate risks Understanding and committing to Compliance Communication Ensuring inter-project communication and integrated execution Ensuring consistency and sharing of best practices Leadership Capabilities E2E Visibility Be skilled in effectively managing virtual teams and have the ability to influence both horizontally and vertically Drive to engage others and have excellent interpersonal, communication and leadership skills Be able to maintain focus on the key project goals and priorities, but also be able to dive into the detail to facilitate problem resolution and ensure project success Cultural sensitivity, diversity, and effectiveness Regulatory Acumen and effective working relationship with Global Regulatory Affairs and Clinical Safety (GRACS) Demonstrated conflict resolution, problem-solving, raising concerns and accountability Education Minimum Requirement Bachelor's Degree in the field of Science, Engineering or related Required Experience and Skills Minimum of eight (8) years' combined and diverse experience in Supply Chain Management, Operations, Technology, Regulatory, or Procurement with a demonstrated record of solid achievements Working in both strategic and tactical space Preferred Experience and Skills Product source changes and change control Proficiency in Microsoft project Flexibility with working schedule and availability to travel Vaccines, biologics, therapeutic proteins, or sterile Working with Global Human Health and 3rd party partners Required Skills Accountability, Accountability, Adaptability, Biopharmaceuticals, Budget Development, Clinical Trial Management, Conflict Resolution, Data Analysis, Decision Making, Feasibility Studies, Global Supply Chain, Innovation, Innovative Solutions, Inventory Management, Knowledge Management, Leadership, Mitigated Risks, Project Management, Project Management Tools, Project Planning, Project Portfolio Management (PPM), Regulatory Compliance, Retail Inventory Management, Risk Evaluation And Mitigation Strategy (REMS), Risk Management {+ 5 more} Preferred Skills Current Employees apply HERE Current Contingent Workers apply HERE US and Puerto Rico Residents Only Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process. As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights, EEOC GINA Supplement We are proud to be a company that embraces the value of bringing together talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively. Learn more about your rights, including under California, Colorado and other US State Acts U.S. Hybrid Work Model Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence. This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as “remote”. The salary range for this role is $129,000.00 - $203,100.00 This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee’s position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs. The successful candidate will be eligible for annual bonus and long-term incentive, if applicable. We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits You can apply for this role through https://jobs.merck.com/us/en (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting. San Francisco Residents Only We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance. Los Angeles Residents Only We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance. 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 No relocation VISA Sponsorship No Travel Requirements 10% Flexible Work Arrangements Hybrid Shift Not Indicated Valid Driving License No Hazardous Material(s) n/a Job Posting End Date 04/10/2026 *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. #J-18808-Ljbffr
Job Description A fantastic and hugely exciting opportunity has arisen for an Operations Executive Director for Biologics clinical and commercial manufacturing at our single-use, multi-product commercialization facility in Dunboyne. Reporting to the Site Lead, this position will drive transformational change for capacity realization and operational excellence to deliver all components of stable manufacturing teams and processes for a diverse and complex Biologics pipeline. This is a new position to establish single accountability across all manufacturing Operations at the site and to drive standardization and simplified ways of workings for optimal utilization and resource agility. This position will provide leadership and operations support on Biologics drug substance (DS) and cell banking manufacturing and release in addition to technology transfer, PPQ, inspection readiness and approval of new products. This position will include leadership across five facilities and 300 personnel within the organization, including days and shift teams. Bring energy, knowledge, innovation to carry out the following: Responsible for all Manufacturing Operations within four state of the art multi-product facilities used for clinical and commercial manufacture of Biologics Drug Substance, a Cell Banking facility and associated Weigh/Dispense and Solution Prep activities. Plans and directs all aspects of production activities associated with manufacturing or technology transfer and ensures that all projects, initiatives and processes are in conformance with established policies, standards and objectives. Serves on the Site Leadership Team for Operations to develop and deliver toward site and organizational priorities and strategy. Ensure right-first-time and stable start-up, including through technology transfer leadership, execution of clinical, PPQ and commercial batches, change management and implementation of process improvements. Drive a strong compliance mindset within the organisation, including proactive safety and quality culture, and adherence to all regulatory expectations. Ownership for ensuring permanent inspection readiness is in place. Ensure production and project milestones are achieved through planning and execution of integrated overall program schedule Establish and deliver on KPI’s in a timely manner, including schedule adherence, training, hiring, uptime, change controls, investigations, CAPAs, capital/expense targets, sustainability targets, yield/volume/cadence/operational availability, Right First Time, and timely documentation closure. Drive standardization, execution and operational excellence by applying Lean principles to foster continuous improvement mindset to deliver a productive and cost-efficient operating model. Manage and develop operations team personnel toward strong, empowered leaders. Build, inspire, reward and develop diverse talent with the capabilities necessary to succeed in manufacture. Develop facility and resource capacity model across all Operations on site. Resolve resource and prioritisation constraints and support resource needs and changes. Drive a strong technical and digital mindset within the department, staying up to date with emerging technologies that will benefit the organization and manufacturing processes. Resolve issues and identify risks in a timely fashion to the relevant on-site and above-site stakeholders. Responsible for prioritisation of proposed risk mitigation plans and/or acceptance of Quality Risks identified as part of the Quality Risk Management Process. Provide clear direction and definition of any new project scope, goals and deliverables, to the site and cross-functional sub-teams on an on-going basis Resolve issues and identify risks in a timely fashion to the relevant on-site and above-site Stakeholders. Manage financial forecasts and workload to achieve departmental headcount and cost improvements General competencies: Strong leadership and interpersonal skills, including leading and coaching direct team to drive a high performance organizational culture that accommodates rapid growth & highly dynamic operating execution. Inspirational leader that leverages data to set the vision and drive outcomes. The desire to continuously learn, improve and grow, and cultivate continued development within the team Innovative thinker, with excellent decision-making and problem-solving skills. Ability to participate in and lead highly effective cross functional teams, build diverse talent, with a passion to build the future of the Dunboyne facility. Ability to influence across organizational layers, as well as outside the site and externally with partners and based on industry benchmarking. Ability to rapidly understand complex business & technical issues including multi-option scenarios to mitigate risk and ensure continuity of supply as well as strategic initiatives. A great communicator, decisive decision maker with a proven ability to deliver excellence. Technical competencies: Proven capabilities in site manufacturing and technical operations, experience of Operational Excellence, Six Sigma and Lean Methodologies and a proven track-record in project management. Proven capabilities and knowledge of Biologics Drug Substance manufacturing, particularly in downstream processes Set clear performance standards; overcome obstacles; hold ourselves and others accountable for achieving results. Knowledge of global and company health authority regulations and applicable systems & GMP requirements. Experience engaging with regulatory agencies including in on-site inspections Sound judgment and comfortable operating in a challenging, fast-paced and sometimes ambiguous environment. Minimum Education/Experience: Degree qualification or equivalent (Science, Engineering, Technical or other relevant studies). Demonstrated leadership with at least 15 years leading in a cross-functional manufacturing environment, including indirect or direct people management experience Demonstrated Biologics manufacturing and technology transfer experience Required Skills: Accountability, Accountability, Change Agility, Consulting, Cross-Cultural Awareness, Data-Driven Decision Making, Decision Making, Driving Continuous Improvement, Equipment Set Up, Fabrication Processes, GMP Compliance, Leadership, Lean Design, Lean Management, Management Process, Manufacturing Processes, Manufacturing Quality Control, Operational Excellence, Organizational Culture, People Leadership, Production Scheduling, Project Management, Raw Material Specifications, Regulatory Compliance, Science {+ 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: 04/3/2026 *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. #J-18808-Ljbffr
A leading pharmaceutical company in Ireland is seeking an experienced Associate Director for Drug Substance Commercialisation. You will oversee the introduction and production of APIs, manage technical support, and lead process improvements. The ideal candidate holds a degree in Chemistry or Chemical Engineering with a strong background in process chemistry. This is a hybrid role that offers opportunities for leadership and innovation in a collaborative environment. #J-18808-Ljbffr
Job Description We have an exciting opportunity for an Assoc. Director, Drug Substance Commercialisation for our site in Ballydine, Co. Tipperary. The successful candidate will manage the provision of technical support for the introduction and production of clinical and commercial active pharmaceutical ingredients (APIs). You will lead process development and scale‑up activities, drive process improvements, and provide technical expertise to resolve significant processing issues. This role combines hands‑on technical leadership with people and project management responsibilities to ensure safe, compliant, and efficient production. Our Ballydine site is the primary commercialisation facility within the network and the hub where new processes are scaled and brought to commercial manufacture. This site supports the introduction and production of clinical and commercial APIs and the transfer of processes and technologies across internal sites and external partners. Key Responsibilities Core Competencies As a member of the Commercialisation Leadership Team, you are responsible for strategy development and implementation. Lead technical support for commercialisation activities across clinical and commercial production, including multiple processes and process steps. Oversee evaluation of raw materials, process fits, optimisation of chemical API routes, and development for scale‑up. Approval of campaign preparation and follow‑ups, safety and environmental reviews, batch record reviews, and ensure regulatory and validation compliance. Conduct process monitoring and time cycle analysis, lead deviation investigations and resolution, and define cleaning processes. Provide process leadership to production campaigns (pre‑PPQ and commercial). Direct chemistry and engineering support for process development activities for new clinical processes and beyond; evaluate scale‑up implications on plant operations, safety, and environment. Manage transfers of processes to other company sites or external partners as required. Ensure laboratory and operational activities are conducted safely and in compliance with current GMP and GLP requirements. Develop and coach team members—delegate appropriately, create growth opportunities, and provide technical, business, and performance guidance. Participate in departmental administration as part of the Technical Leadership Team, including workforce and resource planning, R&D tax reporting, and budget oversight. Contribute to recruitment, development, and assessment programmes and support implementation of site human resources and organisational development plans. Ensure assigned processes and systems comply with site, divisional, and corporate quality standards and provide technical support for internal and external audits and submissions. Functional Leadership Deep technical and subject matter expertise in process development and commercialisation. Solid understanding of new product development and commercialisation, including CMC (Chemistry, Manufacturing & Controls) considerations. Ability to analyse multiple data sources and influence programme decisions based on facts. Proactively identify and escalare risks, drive solutions. Translate priorities into actionable plans and hold teams accountable for delivery. Monitor progress to ensure deliverables meet agreed standards and methodologies. Contribute proactively to technical reviews and allocate resources to meet programme goals. Understand connectivity across clinical development, CMC, and supply chain to enable successful product launch and stable supply. Communicate effectively to build trust, provide coaching, and develop high‑performing teams. Encourage innovative problem‑solving and alternative approaches to achieve results. Your profile Degree (BSc/BEng) or higher in Chemistry or Chemical Engineering. Strong background in process chemistry and engineering principles. Experience with process, equipment, and cleaning validation. Knowledge of cGMPs and production operations. Familiarity with electronic batch records and control systems (e.g., DeltaV). Experience with deviation management systems and regulatory requirements. Financial management and budget awareness. Knowledge of HR, training, process safety management, and environmental policies and procedures. Excellent written and verbal presentation skills. Strong teamwork and cross‑functional collaboration abilities. Performance management, strategic thinking, project management, problem solving, and lean leadership experience. 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 talented and committed people together. The fastest way to breakthrough innovation is when 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 API Manufacturing Change Control Systems Chemical Process Development Clinical Development Clinical Trials Corporate Productions Cross‑Cultural Awareness Cross‑Functional Teamwork Delegation of Authority Environmental Research Equipment Qualification GMP Compliance Leadership Management Process Manufacturing Process Validation People Leadership Process Chemistry Process Improvements Process Optimization Production Process Development Production Support Regulatory Compliance Regulatory Inspections Additional skills (4 more) 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 Flexible Work Arrangements: Hybrid Job Posting End Date: 04/20/2026 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. #J-18808-Ljbffr
Job Description A fantastic opportunity is available for an Executive Director of MS&T to serve as the senior technical leader for our Biologics, single-use, multi-product clinical and commercial manufacturing campus in Dunboyne . This role is central to shaping the future technical capability of the site and delivering sustained excellence across a complex and growing biologics portfolio. Reporting to the Head of Biologics DS Technical Operations , the Executive Director will define and execute the technical vision for the site , driving end-to-end technical excellence across Technical Operations, Process Sciences laboratories, and technology transfer. The role is accountable for accelerating the successful commercialization of a diverse and complex biologics pipeline while ensuring robust, compliant, and reliable manufacturing of commercial products. This newly created position establishes single-point accountability for end-to-end technical performance , integrating upstream and downstream technical operations, process sciences, and other technical functions into a cohesive technical operating model. The Executive Director will provide transformative, hands‑on leadership across biologics drug substance manufacturing at the site where the technical operations team will be involved in model development, process characterization and scaleup within Process Sciences laboratories. The team will also directly support PPQ execution, filing and inspection readiness. Core Responsibilities Technical Ownership & Process Stewardship Serve as the technical owner for site New Product Introduction and Technology Transfer , ensuring a deep, end-to-end understanding of the technical interdependencies between process science and manufacturing execution to enable on-time, right-first-time site and process introduction. Act as the senior onsite technical authority and escalation point during PPQ, early commercial manufacture, and transfers to new nodes, ensuring rapid, decisive resolution of complex technical issues. Hold full accountability for the creation, approval, and lifecycle management of critical site documentation required to support production readiness, including batch records, recipes, and sampling strategies. Provide technical leadership in response to regulatory questions impacting site operations, partnering closely with site CMC to support submissions, commitments, and post-approval changes. Partner with Quality and Operations leadership to support Regulatory information requests , including risk management, deviations, audits, and inspection readiness. Represent site and operational considerations within commercialization and development forums, ensuring manufacturability and scalability are embedded early in development. Lead product lifecycle management activities, implementing process improvements that enhance long-term robustness, compliance, and productivity through disciplined application of MPS. Champion and support execution of the site digital and data strategy to strengthen technical insight and operational performance. Investigations, Root Cause Analysis & Complex Problem Solving Lead high impact, complex investigations (including deviations, OOS/OOT, and contamination or impurity events), setting the standard for rigorous, data-driven root cause analysis and sustainable corrective and preventive actions. Establish and leverage site-level laboratory and scale-down capabilities that serve as the authoritative standard for complex drug substance manufacturing support and advanced analytical investigations, driving continuous improvement through targeted experimentation. Create a strong feedback loop between manufacturing and development organizations, ensuring learnings from commercial supply directly inform process development and networkwide operations. Risk Management, Monitoring & Preventive Action Establish and lead Proactive Process Monitoring strategies from pre-PPQ through the full product lifecycle, including cross-site performance monitoring. Own technical performance stewardship for commercial drug substance processes, proactively identifying and addressing risks to supply, quality, and compliance. Lead cross-site and cross-program technical risk reviews, translating trend data into timely, effective mitigation strategies. Own stewardship of product, process, and unit operation knowledge management to ensure organizational learning and continuity. Change Control, Validation, QMS & Inspection Readiness Own and execute the technical change control strategy , including multisite change assessments and regulatory impact evaluations. Demonstrate deep expertise in the company QMS, providing rapid, authoritative technical responses and defensible evidence packages for regulatory inspections and internal audits, with unwavering focus on data integrity and traceability. Provide leadership across core QMS processes, including APR/CPV, validation, deviations, inspections, and regulatory submissions. Technical Excellence & Innovation (Leadership Accountability) Build and sustain best‑in‑class technical capability at the site, ensuring critical competencies and succession plans are in place and aligned across the network. Lead and enable continuous improvement by shaping how work is performed, identifying opportunities to simplify, standardize, and streamline while maintaining full compliance. Drive external collaboration with academic and research institutes to strengthen the technical talent pipeline and advance innovation in areas of strategic importance. Who You Are You bring the credibility, experience, and leadership presence required to operate at an enterprise level: Advanced degree (B.S., M.S., or Ph.D.) in Engineering or a relevant scientific discipline. Minimum of 15 years’ experience in biopharmaceutical manufacturing and/or development, with a strong foundation in technical and scientific leadership roles. Deep expertise in biologics molecules, drug substance manufacturing, and commercialization. Proven experience leading technical operations at a manufacturing site, including new product introduction and technology transfer. Demonstrated success in regulatory interactions, investigations, and CAPA management. A recognized leader with the ability to influence and align stakeholders at all levels of the organization. Strong talent building capability, combining strategic thinking with operational discipline. Solid business and financial acumen, with the ability to manage multiple, complex programs concurrently. A leadership style characterized by urgency, accountability, change agility, and the ability to inspire high performance. Required Skills Accountability, Availability Management, Business Development, Change Controls, Incident Management, Leadership, Management System Development, Problem Management, Quality Assurance (QA), Service Delivery, SLA Management, Software Configurations, Software Development Life Cycle (SDLC), Testing 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 04/3/2026 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. #J-18808-Ljbffr
