AVP/Head, Global Biologics Network Launch Readiness

Job Description

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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Current Contingent Workers apply HERE

US and Puerto Rico Residents Only:

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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:

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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. 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:

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

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