Jobs · Engineering · North Carolina

Manager - Manufacturing Services - Material Management Team - Night Shift

BioSpace · Holly Springs, NC · 1 mo ago
EngineeringFull-time

About the role

The Manager - Manufacturing Services - Material Management Team - Night Shift plays a crucial role in supporting the 24/7 manufacturing operations of Amgens newest and most advanced drug substance manufacturing plant. This role involves providing leadership and guidance to the team in the Manufacturing Services area, overseeing various material handling processes, and ensuring the safety and quality culture of the department.

Responsibilities

  • Lead a diverse and impactful team of External Workers in GMP operations
  • Be responsible for the safety and quality culture of the department and champion continued improvement
  • Monitor and take appropriate actions to ensure adequate warehouse capacity is available
  • Oversee inventory control and cycle count processes
  • Serve as the owner of Material Transfer Equipment (e.g., preventative maintenance, operability, etc.)
  • Own and/or provide input and support for quality system records (deviations, change control records, CAPA and SOPs) or other records (e.g., business continuity plan, user requirements specifications and risk assessments)
  • Assess the impact of new requirements, changes, processes, and regulations to the department
  • Align with the broader organizational strategy and deliver continuous improvement
  • Support regulatory inspections for areas of responsibilities, including evaluating complex compliance issues and developing playbooks for the inspections

Requirements

  • High School diploma/GED and 12 years of Manufacturing & Operations experience OR Associate's degree and 10 years of Manufacturing & Operations experience OR Bachelors degree and 5 years of Manufacturing & Operations experience OR Masters degree and 3 years of Manufacturing & Operations experience OR Doctorate degree
  • Experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation or resources

Qualifications

  • Proven managerial experience and/or proven technical expertise in a GMP manufacturing drug substance plant that utilizes Single Use technology, Dispensing, Inventory Control
  • Proven expertise in ERP-SAP and inventory management
  • Cross-functional work experience in either Single Use Technology, Supply Chain, Process Development, Quality or Engineering
  • Excellent communication and change management skills, with drive, sense of urgency, high energy, and problem-solving abilities
  • Demonstrated ability to forge and maintain strong relationships with other functional areas
  • Ability to optimally develop and mentor staff to broadly build inventory management expertise to the internal site teams

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