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.
- 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
- 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
**Other functions may be assigned** Basic Qualifications Bachelor’s degree or & 8 years of directly related experience
- 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
Master’s degree & 6 years of directly related experience
Doctorate degree & 2 years of directly related experience
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
- Negotiating skills
- Overall understanding of mechanical systems
- Goal setting
- Capacity Planning/Inventory
- In depth understanding of Manufacturing/Pharma Business.
Amgen - 22 months ago