Career Category

Job Description

A Shift (7:00pm - 7:00am rotating days)

With minimal direction the manager is responsible for leading on the floor operations and staff in Inoculum Prep and Seeds area of Upstream Manufacturing operation. This individual will be responsible for supervising, coaching, hiring, and development of floor staff.

The front line manager will assist in defining area objectives, identifying improvement opportunities, and leading change efforts; effectively directing their team and delivering on short and long term Amgen Operational goals.

Compliance:

• Ensure safe working environment.
• Ensure cGMP and CFR compliance of operating areas.
• Ensure Amgen policies are followed.
• Evaluate and approve reports and protocols.
• 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.
• Assure proper gowning and aseptic techniques are followed.

Process/Equipment/Facilities:

• Demonstrate technical mastery of Upstream processes.
• Ensure maintenance and re-validation of systems.
• Collaborate with cross-functional teams (i.e. QA/QC, F&E, PPIC, 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 manufacturing processes.

Staff Supervision:

• Responsible for staff and team performance.
• Responsible for selection, training, evaluation, staff relations and development of staff.
• Ensure staff members live by the Amgen Values.
• Ensure training programs are maintained.
• Ensure scheduling of production and maintenance activities.
• Interacts with management in optimizing organizational structure and responsibilities.
• Ensure plant safety through auditing and evaluations.
• Ensure gowning and aseptic techniques training programs are maintained.

Administrative:

• Interacts with management in planning, developing and maintaining budget.
• Assist in developing and maintaining department goals.
• Other functional responsibilities may be assigned.

Basic Qualifications:

• Doctorate degree OR
• Master’s degree and 3 years of Manufacturing and Operations experience OR
• Bachelor’s degree and 5 years of Manufacturing and Operations experience OR
• Associate’s degree and 10 years of Manufacturing and Operations experience OR
• High school diploma / GED and 12 years of Manufacturing and Operations experience AND Previous managerial experience directly managing people and/or experience leading teams, projects, programs or directing the allocation of resources

Preferred Qualifications:

• Knowledge and experience within a cGMP or other highly regulated environment including a basic understanding of technical elements across engineering, biological or chemical processing.
• 5+ years’ experience in a cGMP manufacturing facility.
• Strong leadership and team-building skills (coaching, mentoring, counseling).
• Experience with staff capability and team performance improvements.
• Experience with performance management including performance reviews.
• Conflict Resolution skills.
• Analytical problem solving skills.
• Project Management skills.
• Thorough understanding of regulatory requirements.
• Ability to be flexible and manage change.
• Excellent verbal and written communication (technical) skills.
• Excellent computer skills with Microsoft, EBR/MES, Delta V, Electronic quality systems.

Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.

Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people’s lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world’s leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.