Amgen

Mgr Manufacturing - AML 14

Employer
Amgen
Location
Juncos, PR, US
Posted
Aug 22, 2019
Ref
R-81684
Required Education
Bachelors Degree
Position Type
Full time
Are you looking for a challenging new opportunity to test and growth your managerial skills? We have an immediate need for a Manager Manufacturing to join AML's 14 - Formulation and Filling Facility. This is an outstanding opportunity to seek a variety of challenges and responsibilities in support to our manufacturing facility at Amgen Manufacturing Limited in Juncos, Puerto Rico.

The Role

The Manager Manufacturing role is responsible for leading and supervising AML 14 Vial Filling lines in a Third Shift Operation. Responsibility includes maintaining production in full cGMP compliance. Supervises, hires, and develops staff and ensures production schedules are completed.

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
  • Lead 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 re validation 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.
  • Coordinates set up of critical new manufacturing processes.
  • Knowledge in filling / Aseptic process
Staff Supervision:
  • Responsible for selection, training, evaluation, staff relations and development of staff.
  • 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.
  • Administrative:
  • Interacts with management in planning, developing and maintaining budget.
  • Assist in developing and maintaining department goals

You will Need:

Doctorate degree
or

Master's degree and 3 years of experience in the pharmaceutical, medical device or biotechnology industry
or

Bachelor's degree and 5 years of experience in the pharmaceutical, medical device or biotechnology industry.
And

Previous managerial experience directly managing people and/or experience leading teams, projects, programs or directing the allocation of resources.

Beyond that, you will also need:
  • Availability to work on a third (3rd shift)
  • Educational background in Science, Engineering or Business Administration
  • Deviation and CAPA
  • Ensure that all Deviations are triage within the established goal.
  • Leadership and team building
  • Verbal communication
  • Written Communication including technical writing skills
  • Conflict Resolution
  • Analytical Problem Solving
  • Project Management
  • Coaching, Mentoring and Counseling
  • Ability to be flexible and handle change
  • Regulatory requirements
  • Computer literacy
  • Scheduling
  • Presentation Skills


Our broad approach is one of the reasons why we are regularly recognized as a 'Best Place To Work'. We offer a superior benefits package that includes a competitive healthcare plan, an award-winning retirement and stock plan. And between the paid time off, college coach assistance 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 focuses on areas of high unmet medical need and uses 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.