Sr Mgr Manufacturing- AML 6
Amgen - Municipio de Juncos, PR

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SUMMARY
Under minimal direction, the Manager is responsible for managing one or more manufacturing production areas in a manufacturing production facility and ensuring production is maintained in full cGMP compliance. Responsible for supervising, hiring, and developing staff and ensuring production schedules are completed.

FUNCTIONS

Compliance:
  • Evaluate and approve reports and protocols.
  • Ensure cGMP and CFR compliance of operating areas.
  • Revise, update, and review procedures
  • Manage the development and revision of SOPs.
  • Evaluate current operating procedures and recommend changes to management to optimize production. Assure all corporate change control procedures are followed, and Regulatory and QA are notified prior to the changes.
  • Interact with the FDA.
  • Ensure Amgen policies are followed
Process/Equipment/Facilities:
  • Ensure maintenance and revalidation of systems.
  • Collaborate with cross-functional teams (i.e. QA/QC, PPIC, Clinical Mfg, PD, Regulatory, etc.) in completing production activities.
  • Develop, implement and assess solutions for complex problems.
  • Responsible for resolving problems during operation.
  • Oversees set up of critical new manufacturing processes
Administrative:
  • Responsible for planning, developing and maintaining the department budget
  • Develop and maintain departmental goals
  • Assess department capacity against the Long Range Plan for products or potential products manufactured in the plant
  • Interacts with site efforts to ensure consistency in policies and practices
  • Established department mission statements
  • May lead plant operation teams
  • Establishes department wide business practices
  • Optimizes department resources
**Other functions may be assigned** Basic Qualifications Bachelor’s degree or & 8 years of directly related experience
OR
Master’s degree & 6 years of directly related experience
OR
Doctorate degree & 2 years of directly related experience
AND

2 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources. Preferred Qualifications Please find below the Preferred Qualifications:
  • Technical Management experience
  • Process Optimization experience
  • Project Management experience
COMPETENCIES/SKILLS
  • Negotiating skills
  • Overall understanding of mechanical systems
  • Budgeting
  • Goal setting
  • Capacity Planning/Inventory
  • In depth understanding of Manufacturing/Pharma Business.

Amgen - 22 months ago - save job - block