Amgen

AML-14 Syringe Filling Mgr. Manufacturing

Employer
Amgen
Location
Juncos, PR, US
Posted
Apr 27, 2021
Ref
R-117552
Required Education
Bachelors Degree
Position Type
Full time
HOW MIGHT YOU DEFY IMAGINATION?

If you feel like you're part of something bigger, it's because you are. You've earned your degree. How will you use that achievement to reach your goals? Do more with the knowledge you've worked hard to acquire and the passion you already have. At Amgen, our shared mission-to serve patients-drives all that we do. It is key to our becoming one of the world's leading biotechnology companies, reaching over 10 million patients worldwide. Become the professional you are meant to be in this meaningful role.

Manager Manufacturing AML-14: Filling Area - Third Shift/Non Standard S

Live

What you will do

Let's do this. Let's change the world! In this vital role the Front Line Manager is responsible for leading and supervising either a small manufacturing production area, or a section of a larger production area in a Formulation and Filling facility. Responsibility includes maintaining production in full cGMP compliance. Supervises, hires, develops staff and ensures production schedules are completed in a Third Shift, Non-Standard Shift, 12 hours-shift and weekends.

  • Review and approve procedures, reports and protocols.
  • Assure achieve schedule adherence with Supply Chain requirements.
  • Ensure cGMP and CFR compliance of operating areas.
  • Act as a Lead for all Human Performances Deviations.
  • Assure all corporate change control procedures are followed, and regulatory and QA are notified prior to the changes.
  • Interact and participate from internal and external audits.
  • Ensure maintenance and re-validation of processes and systems.
  • Collaborate with cross-functional teams (i.e. Quality Assurance/Quality Control, PPIC, Clinical Manufacturing, Process Development, Regulatory, etc.) in completing production activities.
  • Develop, implement and assess solutions for complex problems.
  • Responsible for selection, training, evaluation, staff relations and development of staff.
  • Control and monitor budget area expenses, including meal penalty and overtime.
  • Lead team to deliver results and achieve goals.
  • Drive and Lead Daily Meeting with the functional area team.
  • Ensure plant safety through auditing and evaluations.
  • Lead the process to maintain focus of the group on continuous improvement and the use of ideas initiative or/and kaizen process in the inspection/packaging areas.
Win

What we expect of you

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.

We are all different, yet we all use our unique contributions to serve patients. The professional we seek is a strong leader with these qualifications.

Additional Preferred Qualifications are:
  • Educational background in Science and/or Engineering.
  • Knowledge on biopharmaceutical compliance.
  • Availability for third and non standard shift.
  • Strong Managerial skills and ability to successfully prioritize a diverse workload to meet deadlines.
  • Experience Managing Deviations and CAPA
  • Ensure triage and deviations are executed to meet deadlines.
  • Verbal and written communication skills in Spanish and English that will include technical terminology.
  • Analytical on problem solving.
  • Project Management and presentation skills
  • Experience with systems to perform job duties (SAP/MES, QMTS, LMS etc.)

Thrive

Some of the vast rewards of working here

As we work to develop treatments that take care of others, so we work to care for our teammates' professional and personal growth and well-being.

  • Full support and career-development resources to expand your skills, enhance your expertise, and maximize your potential along your career journey
  • A diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
  • Generous Total Rewards Plan-comprising health, finance and wealth, work/life balance, and career benefits-with compensation and benefits rated above 4 stars (out of 5) on Glassdoor

Apply now

for a career that defies imagination

Objects in your future are closer than they appear. Join us.

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.