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Amgen Sr. Manager Manufacturing in Juncos, Puerto Rico

Come and grow with us

Are you looking for a meaningful new opportunity to test and growth your managerial and investigation skills? We have an immediate need for a Sr Manager Manufacturing to join AML’s 14 Formulation and Filling Organization. This is an outstanding opportunity to seek a variety of challenges and responsibilities in support to our manufacturing

The Role

The Senior Manager is responsible for managing one or more manufacturing function at a Formulation and Filling facility and ensuring production is maintained in full cGMP compliance. Responsible for supervising, hiring, and developing staff and ensuring production schedules are completed. In addition, this Senior Manager will be responsible for ensuring that the Deviations(Non-Conformance) investigations are completed in a timely manner and taken into consideration all compliance elements.

SPECIFIC RESPONSIBILITIES INCLUDE BUT ARE NOT LIMITED TO:

Compliance:

  • Evaluate and approve reports and protocols.

  • Ensure cGMP and CFR compliance of operating areas.

  • Revise, update, and review procedures/investigational reports

  • 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 regulatory agencies around the world.

  • Ensure Amgen policies are followed

Process/Equipment/Facilities :

  • Ensure maintenance and re-validation of systems.

  • Collaborate with cross-functional teams (i.e. QA/QC, PPIC, Clinical Mfg, PD, Regulatory, etc.) in completing production activities and/or investigation tasks.

  • 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 their team budget

  • Develop and maintain team goals

  • Interacts with site efforts to ensure consistency in policies and practices

  • May lead plant operation teams

  • Establishes department wide business practices

  • Optimizes department resources

Basic Education & Experience for this opportunity the basic requirements are:

Bachelor’s degree and 8 years of experience in GMP regulated environment

OR

Master’s degree and 6 years of experience in GMP regulated environment

OR

Doctorate degree and 2 years of experience in GMP regulated environment

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

  • Educational background in Life Sciences or Engineering

  • Negotiating skills

  • Overall understanding of mechanical systems

  • Overall understanding of Formulation, Filling, Inspection and Devices processes

  • Previous Experience with quality systems

  • Budgeting

  • Goal setting

  • Capacity Planning/Inventory

  • Understanding of Critical Product Quality Attributes

  • In depth understanding of Manufacturing/Pharma Business

The benefits

Our broad approach is one of the reasons why we are regularly recognized as a ‘Best Place To Work’. We offer an outstanding benefits package that includes an award-winning retirement and stock plan. And between the paid time off, and wellness program – and on-site child care and fitness facilities – you will find us focused on your well-being too.

Our culture is what makes Amgen a special place to work. We have a powerful shared purpose around our mission – to serve patients. We respect one another, recognize contributions, and have embedded collaboration, trust, empowerment and inclusion in all that we do.

We equip all our staff members to live well-rounded, healthy lives. Most recently, Amgen added benefits for transgender employees and continues to pride itself on industry-leading, family-friendly offerings for families of all compositions

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.

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.​

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