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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
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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
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General Responsibilities include but are not limited to:
Required Qualifications:
Critical Skills:
Critical Behavioral and Leadership Competencies:
Preferred Qualifications:
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 FillingPreferred 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:
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 - RahwayWhere 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 - $365,000.00This 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. 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:
RegularRelocation:
DomesticVISA Sponsorship:
NoTravel Requirements:
10%Flexible Work Arrangements:
Not ApplicableShift:
1st - DayValid Driving License:
NoHazardous Material(s):
N/AJob Posting End Date:
11/23/2026*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.
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