Manufacturing Manager

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
• Masters degree and 3 years of Manufacturing and Operations experience OR
• Bachelors degree and 5 years of Manufacturing and Operations experience OR
• Associates 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 peoples lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the worlds leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.

Join Us

If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.

Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses.

As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.

Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

Amgen requires all staff in the United States and Puerto Rico to be vaccinated from COVID 19 as a condition of employment. In accordance with applicable law, Amgen will provide reasonable accommodations to staff members who qualify on the basis of a medical reason or a sincerely held religious belief, practice, or observance. Such accommodation may not pose an undue hardship to Amgen, its operations, or its staff.