Associate Director, Sterile Drug Product Operations 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, 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.

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.

• Own operational readiness: SOP deployment, media fills, EM program readiness, cleaning/disinfection validation, scheduling and productio