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Merck · 1 day ago

Associate Director, Process Operations Lead

Rahway, NJ

Full-time

Hybrid

Senior Level, Lead/Staff, Director/Executive

$140K/yr - $220K/yr

6+ years exp

Merck is a leading company in the pharmaceutical industry, focusing on biologics research and development. The Associate Director, Process Operations Lead will support the Next Generation Biologics facility, overseeing production execution and strategic activities to improve clinical campaign timelines.

BiotechnologyHealth CareMedicalPharmaceutical

Comp. & Benefits

No H1B

Responsibilities

Strategic member of the capital project delivery project team providing Operational knowledge & leading efforts in Operational Readiness to deliver and stand up a new GMP clinical facility

Lead a team engaged in both day-to-day production execution and strategic activities aimed at improving the time-to-market for future Clinical campaigns

Oversee the coordination efforts for Drug Substance Manufacturing Execution (Shop Floor Operations) intended to meet the requirements of New Product Introduction (NPI) schedule

Manage the Operations team, which includes hiring and building team capabilities and performance management to meet the operational requirements of the facility as well as provide leadership and personnel development strategies

Drive operational excellence for Right First Time (RFT) batch execution

Oversee production planning and associated activities, integrated with the NGB Multiproduct platform

Ensure operational readiness in cross-functional partnership with other key stakeholders, as required by each Tech Transfer program to the facility. This involves engaging cross-functionally to deliver site-based activities related to the program. Designing a strategy for product-specific adjustments and participating in associated platform Quality Risk Assessments (QRA)

Accountable for the management of GMP systems in support of operations. Develop future breakthrough business solutions, initially leveraging existing resources in the company's network to reduce overall effort and risk and optimizing these solutions to facilitate rapid product launch

Collaborate across the network on sharing best practices and lessons learned, embodying an enterprise mindset in looking at what can be leveraged across the network to reduce work that needs to be done locally

Qualification

GMP ComplianceBiological Drug ManufacturingProcess EngineeringDelta VManufacturing Execution SystemLean ManufacturingLeadershipProblem-SolvingCross-Functional TeamworkAttention to Detail

Required

Bachelor's degree in chemical/biochemical engineering, pharmaceutical sciences, chemistry, biochemistry, biology, microbiology, or related discipline with minimum of 8 years relevant experience, or a Master's degree with minimum 6 years of relevant experience, or a PhD degree with minimum 3 years of relevant experience

Demonstrated experience (8 years minimum) in a GMP-regulated biological drug substance manufacturing environment, ideally with experience of single-use systems

Prior experience of operations team management and monitoring performance

Possess a deep understanding of a manufacturing/operational GMP (Good Manufacturing Practice) environment with detailed knowledge and experience of both upstream and downstream processing

Strong working knowledge of cGMP, Quality Systems (problem, deviations, change management, etc.), Safety for operations

Experience with facility fit assessments, New Product Introduction, transfer of processes to and from clinical site, and clinical manufacturing experience

Delta V and MES (Manufacturing Execution System) knowledge and experience

Ability to perform technical analysis using software such as JMP, efficiency in Microsoft office, project management (plus), communication

Preferred

Experience in Lean Manufacturing & Root Cause Analysis

Previous experience in process engineering, upstream and/or downstream technical support or manufacturing operations for biologics and/or vaccine products

Experience with operationalization of GMP operations and/or large facility builds or renovations as well as ability to work in a fast-paced environment

Proven self-motivation, ability to drive improvements, and inspire others

Demonstrated ability to work effectively as part of diverse teams

Strong problem-solving skills and the ability to overcome technical and organizational challenges

Excellent attention to detail, highly independent with initiative

Excellent troubleshooting and problem-solving skills

Ability to challenge the status quo with a continuous improvement mindset

Strong leadership ability and collaborative skills

Strong analytical and presentation skills

Ability to lift 25 lbs, if required