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Contract Manufacturing Sr Manager (Site Manager)

Employer
Amgen
Location
Thousand Oaks, CA
Start date
Sep 13, 2022
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Job Details

HOW MIGHT YOU DEFY IMAGINATION?

If you feel like you are part of something bigger, its because you are. At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies. We are global collaborators who achieve togetherresearching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. Its time for a career you can be proud of. Join us.

Contract Manufacturing Sr Manager (Site Manager) - US Remote

Live

What you will do

Lets do this! Lets change the world! In this vital role, the Contract Manufacturing Senior Manager (ACDM Site Manager) will support Amgen's external manufacturing network to improve operational competitiveness and ensure uninterrupted global supply of medicines to our patients. In order to continue to provide the supplemental capacity to the Amgen manufacturing network, it is critical that Amgen Contract & Development Manufacturing (ACDM) builds strong business relationships through site engagement and robust governance to ensure quality and supply reliability with our external contract manufacturing network.

* This position can be performed remotely in the contiguous United States

Role Responsibilities:

A key role within the ACDM organization, the Site Manager leads a cross-functional team and serves as the primary management point of contact for each Contract Manufacturing Organization (CMO). The ACDM Site Manager is accountable for ensuring Amgens performance and quality expectations are met at the CMO. The Contract Manufacturing Senior Manager (ACDM Site Manager) will be responsible for the following:

  • Lead cross-functional teams with clear accountability for performance and ensure the quality, cost, and delivery of products from Amgen's Contract Manufacturing sites are consistently met, as well as lead issue resolution, problem solving, and serve as an escalation agent.

  • Direct the identification, evaluation, and selection of contract manufacturers as well as the planning and coordination of product transfers to contract sites.

  • Manage budget development, monitoring and reporting; ensure cost of production targets are met; and actively oversee forecasting, capacity planning and project management.

  • Ensure metrics are in place to measure, track the performance of the contract sites, and lead external or internal operating review meetings. Ensure CMOs execute activities according to Good Manufacturing Practices (cGMP) principles and ACM business practices.

  • Drive continuous improvement at contract manufacturing sites by building robust business processes and reliable relationships with contract site management, and working closely with internal quality, supply chain and process development organizations to ensure contract manufacturing sites are monitored and that corrective actions are implemented in a timely fashion.

  • Demonstrate and apply a strong understanding of Drug Substance Biologics Operations (Small Molecule Drug Substance, Drug Product and Packaging manufacturing, Supply Chain, and Quality experience also welcome).

  • Drive risk management, operations excellence, and other Operations initiatives.

  • Ability to travel 20% Domestic and International

Win

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The Manufacturing professional we seek is a dynamic leader with the following qualifications:

Basic Qualifications

High school diploma / GED and 12 years of Manufacturing or Operations Experience

Or

Associates degree and 10 years of Manufacturing or Operations Experience

Or

Bachelors degree and 8 years of Manufacturing or Operations Experience

Or

Masters degree and 6 years of Manufacturing or Operations Experience

Or

Doctorate degree and 2 years of Manufacturing or Operations Experience

Preferred Qualifications

  • Bachelors in Business Administration, Engineering or Science

  • 8+ years proven experience in protein, Active Pharmaceutical Ingredients, Drug Substance, Drug Product, or packaging manufacturing environment

  • 8+ years working knowledge of cGMP principles, FDA and other regulatory guidelines, and validation principles

  • 5+ years demonstrated ability working with external parties and/or leading cross-functional teams for clinical and/or commercial products

ThriveSome 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 Plancomprising health, finance and wealth, work/life balance, and career benefitswith compensation and benefits rated above 4 stars (out of 5) on Glassdoor

Apply nowfor a career that defies imagination

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

careers.amgen.com

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.

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.


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.

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.

Amgen requires all staff in the United States, Puerto Rico and Canada 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.

Company

We are all different, yet we have this in common: our mission to serve patients. This sense of shared purpose is key to our becoming one of the world’s leading biotechnology companies. It guides us as we continue to launch new medicines and reach millions of patients worldwide.

We live the mission.

We win together.

We thrive on continual challenge.

Our team of 22,000+ scientists and professionals worldwide bring distinct perspectives and experiences to all we do. We leverage our global talent to achieve together—to research, manufacture and deliver ever-better products and greater depth to our mission.

At Amgen, there is a strong correlation between our high level of diversity and performance. Because addressing issues with a wider range of perspectives and approaches leads to more creative problem-solving. Together, we’re transforming the promise of science and biotechnology into therapies that have the power to restore health.

Connect with us to explore how you can Win, Live, and Thrive at Amgen.

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Find Us
Website
Phone
805-447-1000
Location
Corporate Headquarters
One Amgen Center Drive
Thousand Oaks
California
91320-1799
United States
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