Manager, Planning & Scheduling- 1st Shift; Onsite
Listed on 2026-10-09
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Manufacturing / Production
Regulatory Compliance Specialist
Role
Manage and oversee clinical packaging operations at the West Point, PA facility, focusing on packaging execution for clinical supply production.
Responsibilitieslead clinical packaging technicians, plan micro-level scheduling, ensure compliance with cGMP and regulatory standards, manage team development, and drive continuous improvement initiatives. Maintain technical process knowledge, review documentation, and support quality risk assessments.
RequirementsBachelor's in Science, Engineering, or related field with 4+ years' experience in pharmaceutical operations, or equivalent in experience with an associate's degree (6+ years) or high school diploma (8+ years).
Skillsrisk-based decision making, cross-functional leadership, compliance, and process improvement.
Preferredmanufacturing supervisory experience, experience with quality systems like deviation and risk management, and familiarity with Lean/Six Sigma tools.
High-value specificspharmaceutical clinical packaging, cGMP adherence, clinical supply chain management, regulatory compliance, and a focus on operational excellence within a biologics or small molecule pipeline.
Collaborationworks closely with quality, supply chain, and manufacturing teams.
Location/work setupOn-site at West Point, PA, with an estimated 10% travel.
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