Associate Director, Sterile Drug Product Operations Lead

Merck • Rahway, NJ

1d • Hybrid

About The Position

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, Operations 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, Operations 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, Operations 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.

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.
• Proven leadership experience in aseptic drug product manufacturing operations within GMP-regulated environments; clinical or early-stage operations experience strongly preferred.
• 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.
• Antibody Drug Conjugates (ADC)
• Applied Engineering
• Aseptic Operations
• Capability Development
• Capital Projects
• Communication
• Decision Making
• GMP Compliance
• Good Manufacturing Practices (GMP)
• Interpersonal Relationships
• Leadership
• Lean Manufacturing
• Lean Six Sigma Process Improvement
• Management Process
• Manufacturing Quality Control
• Materials Flow
• Operational Excellence
• Operations Support
• Packaging Processes
• People Leadership
• Pharmaceutical Sciences
• Process Improvements
• Production Management
• Production Planning

Nice To Haves

• 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.

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.
• 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.
• 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.

Benefits

• medical, dental, vision healthcare and other insurance benefits (for employee and family)
• retirement benefits, including 401(k)
• paid holidays
• vacation
• compassionate and sick days

What This Job Offers

• Job Type: Full-time
• Career Level: Director
• Number of Employees: 5,001-10,000 employees