Manager Manufacturing - AML6 Drug Substance

HOW MIGHT YOU DEFY IMAGINATION?

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- AML6 Drug Substance

Multiple positions available.

Live

What you will do

Let's do this. Let's change the world! In this vital role you will have a meaningful role for AML6 Drug Substance (DS) facility by leading the day to day activities and be accountable for supervising, hiring, and developing staff. Ensuring floor activities are completed on time while meeting safety, quality, and financial objectives in a non-standard shift operation. Specific responsibilities include but are not limited to:
  • Management, planning, lead and oversight of DS Downstream or Upstream manufacturing processes.
  • Ensures that manufacturing facilities, equipment, processes, and procedures are compliant with cGMP requirements and/or other applicable regulations.
  • Make sure that written procedures describing the manufacturing operations are controlled and followed. Also ensuring that area staff are trained to perform assigned production activities.
  • Guarantee that the manufacturing activities follow approved cGMP procedures and are documented according to cGMP requirements.
  • Responsible for ensuring that risks are identified, assessed and corrected to ensure the safety, purity, quality, and effectiveness of the product(s) manufactured.
  • Evaluate and maintain an adequate number of personnel who possess the applicable combination of education, experience and trainings in accordance with cGMP requirements.
  • Report non-conformances promptly to the Quality unit and investigate per procedures.
  • Manage and close corrective actions and preventive actions (CAPA) according with the procedures.
  • Ensures the requirements of the Quality Management System are fulfilled.
  • Alerts senior manager of significant quality, compliance, supply and safety risks.
  • Provides input for Management Reviews.
  • Lead continuous Improvement initiatives, programs and projects.
  • Support first, second, third, weekends and 12hrs shifts including extended hours, as per business needs.
  • Interview and Hiring staff as required.
  • Maintain the finite schedule updated.
  • Participate on triage and schedule meeting to discuss important hot topics.
  • Generate and close deviations and work with the preventive actions to avoid recurrence.
  • Ensure manufacturing areas are inspection ready and be prepared to present to different auditors.
  • Maintain staff Kronos updated and approved payroll request and timesheet.


Win

What we expect of you

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

Doctorate degree
OR
Master's degree and 3 years of Manufacturing and/or Operation support experience in GMP regulated industry
OR
Bachelor's degree and 5 years of Manufacturing and/or Operation support experience in GMP regulated industry
And
Previous managerial experience directly managing people and/or experience leading teams, projects, programs or directing the allocation of resources .

Beyond that, additional preferred qualifications are:

  • Education discipline/background in Business Administration, Mathematics, Statistic, Life Sciences and/or Engineering
  • 8+ yrs of GMP regulated manufacturing work experience if educational background is from other fields
  • Biotech/Pharma industry experience
  • Lead or Managerial Manufacturing previous experience
  • Lean Certified and/or experience working in Operational Excellence teams and/or projects
  • Coaching, Mentoring and Counseling previous experience
  • Verbal and written communication in English and Spanish, including technical writing and Computer literacy


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: careers.amgen.com

Equal Opportunity Statement

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

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

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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.

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