Executive Director, Engineering (FLEx Co-Lead)

Job Description FLEx is a set of multi-modality Drug Product development and GMP clinical manufacturing assets constructed in the Rahway, New Jersey site, to support our company’s diverse and growing pipeline of oral and injectable therapeutics and vaccine drug products.

Operational leadership of the FLEx complex is shared across three Executive Director roles, and includes operations in RY buildings 53, 119, 880 and 80B that support end-to-end GMP clinical supply manufacture and product/process development, as well as oversight of Enterprise Resource Planning systems (SAP, PAS-x), the Drug Product Quality Management System (QMS) and the Data Analytics platforms that support the areas.

Facilities in RY119, RY53, RY80B and RY880 have been operational since 2023 and currently run a 5-day, 2-shift operating schedule. However, operating schedule may change over time based on pipeline need (eg. Move to a 7-day, 24-hour schedule). Aligned with the design intent of FLEx, the plant is in a state of significant growth as the result of pipeline expansion and adoption of Launch Preparedness approaches.

Significant capital investment is proceeding in both the sterile and non-sterile modalities. It is expected that this level of change to both footprint and installed capability will continue as our company's Research Labs sees pipeline shifts.

Being able to adeptly forecast and deliver new technology elements in a manner which adheres to budgetary and timeline commitments and is least disruptive to continued operations is a key responsibility of FLEx Lead role.

The three FLEx Co-Lead roles are jointly accountable for all activities associated with FLEx, including the realization of the overall FLEx intent in the Pharmaceutical Sciences and Device Development (PSDD) organization. This includes operating model, culture, talent development, technology introduction, process/product development and compliance.

To ensure success, each of the FLEx co-leads is focused on a different part of the infrastructure and set of products/modalities. The current opening is for FLEx Sterile 2 and is focused on the new Optima sterile filling installation which is scheduled to be Ready-For-Science in early 2030.

The FLEx 2 Sterile suites contains a highly integrated and state-of-the-art sterile formulation and filling suite with a full complement of sterile support equipment systems (eg. DHO, Autoclave), capable of processing highly potent and higher-level biosafety pharmaceuticals and vaccines, to support pre-clinical through late-phase manufacture.

The equipment is highly dependent on robotic operations and novel containment systems for worker safety and sterility assurance. Ensuring FLEx is positioned to deliver clinical supply for speed to FIH and clinical development, and to answer the critical research problem statements required for successful commercial launch is the responsibility of the FLEx Sterile Lead.

Understanding scaling between lab, pilot plant and our company's manufacturing division commercial sterile filling lines is a critical skillset of the FLEx Sterile Co-Lead. Equally important is an understanding of the pipeline and ability to direct the right programs into FLEx, to optimize utilization and best leverage internal capability on high value assets.

Within each modality, the FLEx Co-Lead is responsible for providing tactical and strategic level direction to the cross-functional program teams working in the FLEx assets across RY880, RY53, RY53 and RY80B. This extends from materials management, GMP manufacture, formulation development, and bulk Drug Product release.

Close connectivity with upstream Drug Substance and downstream packaging partners is required to optimally support clinical development and product commercialization. The FLEx Co-Lead oversees performance management processes that govern operations, tier, clinical siting and global compliance councils.

Key performance indicators range from quality and regulatory compliance, operational excellence, pipeline program progression, financial, talent development and culture.

Key to the realization of the FLEx vision is the creation of a collaborative scientific community that inspires innovation and enables speed of new product development from clinical research to commercialization of robustly understood products and processes.

Each FLEx Co-Lead has direct management responsibilities for a staff that is expected to grow to 100 full-time employees plus a large population of GMP service providing contractors. There is an additional matrixed reporting relationship to functional groups in development, quality, safety, facilities management, analytical, finance and regulatory.

As noted, FLEx is designed to be a facility that evolves to meet company and pipeline needs over its lifespan. FLEx Co-Leads are responsible for understanding the external and internal drivers of change, translating that FLEx strategy, securing support for that strategy with partners and our company's research division senior leadership, and executing on plans to deliver the strategy.

This is inclusive of business process development, governance structure, talent development, new technology introduction, and cultural attributes required for the area’s success.

Significant focus is placed on adoption of new digital capabilities that allow for better access to high-fidelity data, more efficient clinical product release, improved product/process characterization, and more successful commercialization of new products into our company's manufacturing division .

The FLEx Co-Lead role is based in New Jersey and reports to the Associate Vice President of Pharmaceutical Operations and Clinical Supply (POCS) in our company's research division . General Responsibilities include but are not limited to: Setting of a strategic vision for FLEx aligned to the PSDD and our company's research division strategies, and the long-range operating plan to achieve that vision.

Overseeing operations in the set of FLEx assets, through a thoughtful and engaging tier process jointly managed with partner groups in our company's manufacturing, research lab, GSE and GWES. Establishing an end-to-end mindset and value stream for delivering clinical supplies agilely to ensure speed to clinic and best filing process.

Creating an entrepreneurial culture in FLEx which values diversity in all its forms as a catalyst to innovation and product creation, recognizes the freedom to experiment and fail, is a safe environment to challenge, nurtures a keen sense of belonging, and motivates all to achieve their potential.

Collaborating with peer leaders in our company's research, manufacturing and corporate divisions, from Discovery to commercial manufacturing, and across the product value stream, to anticipate pipeline needs, prioritize facility on critical business needs. Establishing and managing financial budgets and forecasts associated with the FLEx assets, both with respect to expense and capital expenditure.

Defining and demonstrating operational excellence in a clinical manufacturing setting, across a spectrum of activities and inclusive of capital project delivery. Creating ERP/MES/Data systems that allow scientists to fully access available data via intuitive interfaces, to facilitate process development, streamline clinical supply and improve efficiency of operations.

Maintaining FLEx facility and equipment systems in a state of permanent inspection readiness.

Recruitment and development of staff, through close partnership with external and academic partners, thoughtful objective setting including stretch leadership and/or technical assignments that deepens skillsets, learning opportunities that broaden experience and a comprehensive rewards and recognition system that promotes success across a range of technical and behavioral dimensions.

Member of site and global leadership committees (e.g. safety, quality).

Required Qualifications: Academic background: BS or MS degree in Chemical Engineering, Biochemical Engineering, Biomedical Engineering, Materials Science, Mechanical Engineering, Pharmaceutics, Pharmaceutical Chemistry, Pharmaceutical Sciences, Chemistry, Biochemistry, or a related field with 10 years of relevant experience Or PhD in Chemical Engineering, Biochemical Engineering, Biomedical Engineering, Materials Science, Mechanical Engineering, Pharmaceutics, Pharmaceutical Chemistry, Pharmaceutical Sciences, Chemistry, Biochemistry or a related field with 8 years of relevant experience Critical Skills: Deep subject matter expertise in pharmaceutical development and manufacturing, across modalities, formulation approaches and product types Minimum 2 years of management responsibility and experience developing staff Fluency in the clinical quality management system and CMC process, across modalities and inclusive of facility/technology development and qualification Effective communication and collaboration skills, with a diverse group of stakeholders both inside and outside FLEx Demonstrated project management skills Critical Behavioral and Leadership Competencies: Leadership Skills: Strong ability to lead engineering, technical, and operational teams, drive organizational change, and influence at all levels of the organization.

Takes proactive steps to strategically shape the future of the organization. Talent Development: Provides timely feedback and coaching to talent across POCS. Actively builds the best team and manages performance. Demonstrated commitment to fostering diversity, inclusion, and belonging. Execution Excellence: Drives operational excellence by clarifying and translating priorities into actionable steps.

Business Savviness: Applies a deep understanding of our company's research division business areas, inclusive of external landscape, to shape strategy. Demonstrates understanding of connectivity between clinical development, chemistry, manufacturing and control (CMC) and human health, balancing the needs of patients and ensuring successful launch and stable supply of product.

Collaboration & Change Catalyst: Excellent cross-functional collaboration, stakeholder management, and communication skills. Actively engages in two-way communication to build trusting relationships. Experience leading organizations through transformation and growth.

Data Driven Decisions & Risk Management: Challenges teams to gather and compare information/data from multiple sources to influence program decisions with facts and data. Strong analytical, decision-making, and problem-solving skills.

Entrepreneurial mindset, focus on delivering customer value Resilience in a diverse and evolving environment, able to coach others to be resilient Emotional maturity to be successful in a shared leadership role and where common responsibilities are distributed amongst the 3 FLEx Co-Leads Ability to inspire and motivate others in a team environment Preferred Qualifications: Relevant experience managing an operating pharmaceutical plant, either in research or commercial manufacturing, and especially one operating shifts beyond a 5-day, 8-hr shift schedule.

Experience in pharmaceutical capital project management and specifically design, construction, delivery, and validation. Pharmaceutical and vaccine product development and commercialization experience, including filing and launch.

Required Skills: Capital Project Management, Chemical Engineering, Clinical Manufacturing, Clinical Supplies Management, Commercialization, Data-Driven Decision Making, Engineering Standards, Inspection Readiness, Manufacturing Quality Control, Operations Management, People Leadership, Product Commercialization, Product Development, Quality Management Systems (QMS), Sterile Filling 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.

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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: 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 The primary location for this posting is: USA - New Jersey - Rahway Where required by law, the compensation range for this role is provided below.

The salary range for the primary location of this role is: $231,900.00 - $365,000.00 This range reflects the Company's reasonable expectation of the base salary applicable to this role at the time of 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 .

Additional location(s): Please note the salary range above applies to the Primary Location of the position. Where a role has other listed locations, different compensation guidelines may apply. You may find the salary ranges for additional locations below.

If the salary range is not listed for the location you are applying to, our Talent Acquisition team will provide further information to you relevant to your location.

Additional location(s) Compensation Information: 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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