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Merck · 1 day ago

Associate Director, Sterile Drug Product Operations Lead

USA - New Jersey - Rahway

Full-time

Hybrid

Senior Level, Lead/Staff, Director/Executive

$126K/yr - $199K/yr

6+ years exp

Merck is a leading global healthcare company, and they are seeking an Associate Director to lead the operational strategy and performance of their sterile drug product manufacturing facility. The role involves shaping the operational culture, ensuring compliance with regulatory standards, and driving operational excellence in a highly regulated environment.

BiotechnologyHealth CareMedicalPharmaceutical

Comp. & Benefits

H1B Sponsored

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

Qualification

Aseptic OperationsCGMP ComplianceOperational ExcellenceLean ManufacturingLeadershipAntibody Drug Conjugates (ADC)Capability DevelopmentProduction PlanningProject ManagementInterpersonal RelationshipsPeople LeadershipManufacturing Quality ControlCommunicationDecision Making

Required

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

Preferred

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