Associate Director, Engineering - Sterile Production Lead

Job Description

The Formulation, Laboratory, and Experimentation (FLEx) Center in Rahway, New Jersey, features a cutting-edge sterile drug product cGMP clinical supply manufacturing facility, known as FLEx Sterile.  The FLEx Sterile facility is poised to play a pivotal role in the long-term success of delivering our clinical pipeline to patients worldwide, encompassing a diverse range of product modalities, including sterile small molecules, biologics, vaccines, and antibody-drug conjugates (ADCs).  A large-scale capital project, known as the FLEx Sterile Expansion project, is currently underway. 

 

The FLEx Sterile Expansion project is nearing completion of its detailed design phase and has begun construction and commissioning and qualification of the long lead time process equipment. Upon its completion, the expansion project will more than double the capacity of the existing FLEx Sterile Facility by adding a second clinical filling/lyophilization suite, a formulation suite, a sterile supply suite, and various supporting infrastructure and utilities.

 

As we prepare to bring this asset online, we are seeking an Associate Director, Engineering, to lead the end-to-end operational strategy, execution, and performance of the facility. This leader will shape the operational culture from the ground up, ensuring the site is staffed with exceptional talent, achieves operational readiness on an aggressive timeline, and continuously delivers operational excellence in a highly regulated, patient-centric environment. 

 

Early on, this leader will partner closely with engineering, quality, validation, EHS, supply chain, and program teams to align operational needs with the C&Q plan, ensuring equipment, utilities, cleanrooms, and process areas are fit for use and ready for clinical manufacturing campaigns. They will establish the operating model, define core processes, and set performance standards that meet cGMP, aseptic processing, and safety requirements.  In parallel, the Associate Director, Operations will design and execute a comprehensive hiring and staffing plan, recruiting and developing a high-performing team across production, scheduling, and operations support. They will craft role profiles, training curricula, and competency frameworks that enable a robust, compliant operation and foster a culture of accountability, continuous learning, and right-first-time execution. This leader will be deeply involved in onboarding and capability building, ensuring operators and support staff are confident in aseptic behaviors, gowning, environmental monitoring awareness, batch record execution, and deviation prevention.

 

As the facility transitions from C&Q into routine operations, the Associate Director, Engineering will own operational readiness. This includes approval and deployment of SOPs, master production schedules, visual factory and tiered daily management, material flow and warehousing strategies, production planning and finite scheduling, line-clearance and batch-release coordination, and readiness drills for aseptic interventions and media fills. They will drive readiness of EM programs, cleaning and disinfection procedures, equipment maintenance plans, and tech transfer playbooks, partnering with technical operations, quality, and engineering to ensure process robustness and compliant execution.

 

Operational excellence will be the hallmark of this role. The Associate Director, Engineering will implement a performance system grounded in safety, quality, delivery, cost, and people metrics—leveraging lean methodologies, problem-solving, and statistical thinking to reduce variability, elevate yield, and prevent defects. They will champion digital tools and data-driven decision-making, deploy right-sized standard work, and lead kaizen events to continuously improve throughput and reliability.

 

This leader will own the short- and long-range capacity plans, align resources to clinical portfolio needs, and ensure predictable, on-time delivery of clinical batches with impeccable GMP compliance for the filling line asset in scope of the expansion project.

 

Key Responsibilities

• Build and lead the Operations organization from inception, including recruiting, staffing plans, role design, onboarding, and capability development.

• Partner with engineering, validation, and quality to align operational requirements with C&Q activities; ensure equipment and facilities are released for GMP use and ready for clinical campaigns.

• Establish and maintain GMP-compliant operating procedures, standard work, and training programs for aseptic manufacturing, materials management, and facility operations.

• Serve as the system owner from the business unit for the process equipment within the filling, formulation, and sterile supply suites.  Emphasis will be placed on the filling line, filling isolator, and lyophilizer. 

• Own operational readiness: SOP deployment, media fills, EM program readiness, cleaning/disinfection validation, scheduling and production control, and readiness drills.

• Lead daily operations post-authorization, including production execution, scheduling, material flow, inventory controls, and collaboration with partner groups for tech transfers.

• Implement an operational excellence system: tiered daily management, visual performance boards, KPI tracking (safety, quality, delivery, cost, people), deviation reduction, and continuous improvement.

• Ensure robust compliance with cGMP, aseptic processing standards, data integrity, and regulatory expectations for clinical manufacturing.

• Drive cross-functional coordination with Quality, Technical Operations, EHS, Supply Chain, and Program Management to deliver on clinical timelines and batch release commitments.

• Manage capacity planning, scenario modeling, and resource allocation to meet clinical demand and portfolio priorities.

• Establish a culture of safety, empowerment, and accountability; lead with clarity, transparency, and a focus on patient impact.

 

What Success Looks Like

• Facility transitions from C&Q to cGMP operations on schedule, with flawless execution of containment verification, media fills and audit readiness activities.

• A fully staffed and trained operations team performs with high reliability, compliance, and morale.

• Standard work and SOPs are deployed and adhered to; deviations and interventions trend downward quarter-over-quarter.

• Clinical batches are delivered on time, at an acceptable yield, with robust quality outcomes.

• Continuous improvement pipeline is active and measurable, driving gains in throughput, cycle time, and cost without compromising quality or safety.

• Provide manufacturing and operational expertise within the manufacturing team, including areas such as sterile supply, formulation, isolators, filling, lyophilization, capping and visual inspection.

• Ability to solve complex problems and take new perspectives on existing solutions with a desire to continuously learn, improve and develop. Bringing in appropriate stakeholders when required.  

• Conduct all work activities with strict adherence to the safety and compliance culture on site. 

• Support the authoring of electronic batch records, sampling plans, and standard operating procedures.  

 

Education Minimum Requirements: 

• Bachelor’s degree in business, engineering, pharmaceutical sciences or related field with a minimum of 8 years of relevant experience. 

• Master’s degree with 6 years of relevant experience, or a

• PhD degree with 4 years of relevant experience.

 

Required Experience and Skills:

• Proven leadership experience in aseptic drug product manufacturing operations within GMP-regulated environments; clinical or early-stage operations experience strongly preferred.

• In-depth technical and operational knowledge of aseptic filling lines, isolators, and lyophilizers. 

• Demonstrated success in building and scaling operations teams, including hiring, training, and developing frontline and leadership talent.

• In-depth understanding of cGMP, aseptic processing principles, contamination control strategies, and data integrity requirements.

• Strong command of operational excellence methodologies (Lean, Six Sigma), daily management systems, and KPI-driven leadership.

• Effective cross-functional collaboration and communication skills; ability to translate complex technical requirements into clear operational plans.

Preferred Experience and Skills:

• Hands-on experience with C&Q, facility start-up, media fills, environmental monitoring programs, and readiness for aseptic operations.

• Experience applying consultative skills: ability to influence decision making, ability to interact with all levels of the business (senior leaders to shop floor working teams).

• Project management skills (demonstrated experience in managing large project teams).

• Ability to Lead and drive the Process Hazard Analyses and Quality Risk Assessments as necessary. 

 

The role is based out of our Corporate Headquarters in Rahway, New Jersey and reports to the Enabling Technologies lead within Pharmaceutical Operations and Clinical Supply. 

 

Required Skills:

Adaptability, Chemical Engineering, Customer-Focused, Data-Driven Decision Making, Drug Product Development, Estimation and Planning, Manufacturing Quality Control, Pharmaceutical Process Development, Process Control Automation, Process Optimization, Product Formulation, Safety Compliance, Strategic Thinking, Technical Mentoring, Technical Writing

Preferred Skills:

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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

$142,400.00 - $224,100.00

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

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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:

Domestic

VISA Sponsorship:

Yes

Travel Requirements:

10%

Flexible Work Arrangements:

Not Applicable

Shift:

1st - Day

Valid Driving License:

No

Hazardous Material(s):

N/A

Job Posting End Date:

04/17/2026

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