Senior Manager, Drug Product Device Assembly and Packaging (DAP) System User

Role: Lead Device Assembly and Packaging (DAP) SME for a greenfield aseptic Drug Product facility at Johnson & Johnson, overseeing design, start-up, qualification, and routine operations. Objectives include ensuring compliance with cGMP, contamination control, and regulatory standards, while shaping operations and culture during facility build-out. Responsibilities encompass authoring and reviewing technical documentation, collaborating with global teams on process design and engineering deliverables, developing operator training, supporting validation and qualification activities, and managing spare parts and operational readiness. The role transitions into a Senior Production Manager overseeing Device Assembly and Packaging teams.

Qualifications: Bachelor's degree in Life Sciences, Pharmacy, or Engineering required; Master's preferred. Minimum 8 years in pharmaceutical industry with sterile Drug Product manufacturing experience, including 3–5 years as a Subject Matter Expert in Device Assembly and Packaging for aseptic parenteral products. Must possess deep knowledge of aseptic processing, contamination control, and cGMP compliance; experience with automated and robotic DAP systems. Strong problem-solving, cross-functional leadership, and stakeholder influence skills are essential.

Preferred: Lean/Six Sigma certifications.

High-Value: Aseptic manufacturing, Device Assembly and Packaging, parenteral products, regulatory compliance, facility start-up, experience in high-tech sterile environments. Location: Wilson, North Carolina, with >75% travel during project design and build phases.