Our Global Biologics Operations (GBO) organization is responsible for manufacturing and supplying commercial biologic products that support over $30 billion in annual sales. GBO is now preparing to transform into a true launch powerhouse—capable of smoothly, quickly, and efficiently commercializing and supplying more products than ever before. Reporting directly to the Senior Vice President (SVP) of Global Biologics Operations, the Head of Global Biologics Launch Readiness will be accountable for preparing our internal biologics manufacturing sites—Dunboyne, Dublin, Carlow, and Wilmington—to successfully execute multiple New Product Introductions (NPIs), Process Performance Qualifications (PPQs), Pre-Approval Inspections (PAIs), and best-in-class multi-product launch manufacturing. To achieve this, this highly experienced leader will lead cross-functional launch readiness teams at each site, drive the execution of the launch readiness strategy, and work closely with site leadership, development and commercialization teams, partner functions including Global Science Engineering and Commercialization (GSEC), Quality, and CMC Regulatory Affairs, as well as, the GBO Leadership Team (LT). This role also involves building long-term capability and expertise in launch readiness across the network to ensure sustainability and scalability of future product launches. The Head, Global Biologics Network Launch Readiness will: Lead and manage cross-functional and cross-site launch readiness teams to prepare internal Global Biologics Operation (GBO) sites for successful PPQs and PAIs for late-stage pipeline biologics.

Drive the launch readiness and launch effectiveness hoshin/strategy across the internal manufacturing network.

Partner with site leadership to drive preparedness for agile and efficient multi-product manufacturing operations.

Establish and lead a cross-functional launch readiness governance model across global sites and functions.

Build and chair a global launch readiness council, providing visibility and escalation paths for cross-site readiness issues

Define and operationalize a global biologics operations launch readiness framework, including key milestones, success criteria and KPIs

Develop budgets for launch readiness efforts and ensure budget adherence, resource allocation, and cost efficiency

Serve as single point of accountability for end-to-end operational readiness

Develop and maintain a global NPI/launch readiness dashboard, providing the SVP and executive team with clear line of sight into launch risk, site readiness and required interventions

Drive implementation of best practices in NPI planning, launch readiness governance. Collaborate with GSEC, Procurement, Supply Chain, and other enabling functions to develop and implement 'platform' concepts that accelerate and streamline new product introductions.

Develop launch playbooks, knowledge management tools and training programs for site and functional teams

Partner with regulatory affairs, quality and site tech ops to ensure manufacturing readiness aligns with regulatory strategy and filing timelines

Education: Bachelor’s Degree in (Bio)Chemical Engineering or related discipline required; PhD preferred.

Required Experience and Skills: 20+ years of deep and broad expertise in GMP biologics drug substance and sterile drug product manufacturing

Experience across multiple biologic modalities (such as recombinant proteins, monoclonal antibodies, engineered antibody formats, fusion proteins etc.)

Proven track record of planning and executing multiple NPIs, PPQs, PAIs, and commercial launches of cell culture-derived biologics is a pre-requisite

Proven experience managing multi-product biologics manufacturing operations and ensuring readiness for concurrent launches

Familiar with tools and processes for launch readiness monitoring, knowledge management and network level governance

Experience in supply chain operations; experience in leading cross-functional teams in support of manufacturing operations at internal sites or external partners.

Expertise in Lean Manufacturing concepts and systems

Strong track record of leading cross-functional teams across sites and functions within a global biopharma network.

Strategic thinker with operational rigor, stakeholder management skills, and the ability to embed sustainable capabilities within cross functional teams

Strong people/ team leadership experience, including leading and motivation teams. Experienced in establishing performance metrics and holding people accountable for results.

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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 $276,600.00 - $435,400.00 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. 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Employee Status: Regular Relocation: VISA Sponsorship: Travel Requirements: Flexible Work Arrangements: Hybrid Shift: Valid Driving License: Hazardous Material(s): Required Skills: Budget Development, Business, Change Management, Clinical Trial Management, Communication, Cross-Functional Team Leadership, Empathy, Feasibility Studies, Management Process, Mentoring Staff, Performance Monitoring, Personal Initiative, Project Scheduling, Resource Allocation, Risk Management, Stakeholder Management, Vision Casting Preferred Skills: Job Posting End Date: 07/31/2025 *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.

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