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Sr. Associate Manufacturing at Amgen

Posted in Manufacturing 30+ days ago.

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Location: Thousand Oaks, California





Job Description:

Amgen

Job ID: R-92295
Location: Thousand Oaks, CA, US 91360

Amgen Contract Manufacturing (ACM) is a strategic dimension of Amgen's manufacturing network leveraged to improve operational competitiveness and ensure uninterrupted global supply of medicines to patients. ACM leads a continually changing combination of CMO sites and site/product combinations located all around the globe. This is an outstanding opportunity to effectively engage with Amgen's internal operations in a holistic way while being on the forefront of industry trends and ground breaking technologies through our external parties. The Sr. Associate Manufacturing role is a supportive internal Amgen role that uniquely will work with Amgen and external supplier teams to ensure the external Amgen Manufacturing network delivers quality supply of our vital medicines on time. The role will have but is not limited to the following responsibilities:

Responsibilities:

Manufacturing operations: Via cross functional team engagement, collect and enter data in budget spreadsheets; routing/monitoring/tracking inputs to contracts, confidentiality disclosure agreement(s), scope of work agreement(s), request for pricing/information, supply agreement(s) etc. Own NC Class I records, CAPA, and change control records.

Site performance monitoring: Facilitate collection, entry, and tracking data for site performance metrics; maintain/update list of improvement opportunities at contract sites; daily duties will include running appropriate internal meetings and issuing meeting minutes, analysis of data and metrics, improving tools used by the Work Center Teams (WCT), issuing purchase requests, completing goods receipts, and active participation in WCT internal meetings.

Project Management and Technology transfers: Track, follow up and drive action on activities in assigned projects. Track timeline and coordinate transfer team activities to achieve seamless product transfer to the contract site(s); participate in risk management activities as part of transfer; identify and raise issues to the right level.

Basic Qualifications

Master's degree

OR

Bachelor's degree and 2 years of Biotech/Pharma experience

OR

Associate's degree and 6 years of Biotech/Pharma experience

OR

High school diploma / GED and 8 years of Biotech/Pharma experience

Preferred Qualifications


  • Bachelor's in Business Administration, Engineering, or Science-related field

  • 2+ years of experience in protein, small molecules, API, DS, DP, or packaging manufacturing environment

  • 2+ years in roles requiring knowledge of cGMP principles, FDA and other regulatory guidelines, and validation principles

  • 1+ years of project management experience leading multi-functional and/or multi-location team

  • Demonstrated project management skills.

  • Proficient in information systems.

  • Problem-solving and critical thinking.

  • Understanding of contractual requirements.

  • Technical writing and multi-level communication skills.

  • Basic financial acumen.

  • Strong quantitative and analytical skills.

  • Demonstrated ability to work effectively in collaborative/team environment.

  • Demonstrated ability to take initiative and action.

  • Ability to work in a fast paced, multifaceted environment.



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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