Γραφείο Διασύνδεσης & Σταδιοδρομίας

Description

Amgen Job Description 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 in Life Sciences or Engineering & 8 years of Pharma/Biotech/Medical Device industry experience

OR

Master's degree in Life Science or Engineering & 6 years of Pharma/Biotech/Medical Devices industry experience
OR
 Doctorate degree in Life Science or Engineering & 2 years of Pharma/Biotech/Medical Device industry 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 Preferred qualifications

• Bachelor degree in Mechanical, Chemical or Electrical Engineering is preferred
• Previous experience in Vials or Syringe Filling processes and or Component Preparation
• Negotiating skills
• Overall understanding of mechanical systems
• Budgeting
• Goal setting
• Capacity Planning/Inventory
• In depth understanding of Manufacturing/Pharma Business