Job Title: Specialist - Manufacturing Investigations
Location: North Carolina, USA
Amgen is a global leader in biotechnology, dedicated to serving patients battling serious illnesses. With a history of pioneering breakthroughs since 1980, Amgen is transforming the future of healthcare, focusing on four therapeutic areas: Oncology, Inflammation, General Medicine, and Rare Disease. Through our innovative research, manufacturing, and delivery of medicines, we impact the lives of millions of patients worldwide.
Amgen is investing in its FleX Batch facility, the most advanced drug substance manufacturing plant to date. This facility will combine cutting-edge technology, disposable systems, and Industry 4.0 capabilities to provide the flexibility needed for modern operations. It will also incorporate sustainability measures to help achieve Amgen's goal of becoming a carbon-neutral company by 2027.
As a Specialist - Manufacturing Investigations, you will play a vital role in investigating major deviations in Amgen's North Carolina Biologics Drug Substance Manufacturing plant. Your responsibilities will include:
Deviation Investigation Management:
Lead major investigations by assembling teams, performing root cause analysis, developing CAPAs (Corrective and Preventive Actions), and documenting findings in compliance with industry standards. You will drive continuous improvements in the investigation process.
Cross-Functional Leadership:
Collaborate with teams across Process Development, Facilities & Engineering, Automation, EHSS, and Quality. You will effectively coordinate these teams to ensure timely resolution of deviations.
Regulatory & Internal Communication:
Present your findings to regulatory inspectors, internal auditors, and management. You will also communicate investigation progress clearly to various stakeholders.
Problem-Solving & Process Improvements:
Apply inductive and deductive reasoning to investigate complex issues and implement structured problem-solving approaches. You will also develop tools to track investigation progress and ensure on-time resolution.
Learning & Collaboration:
Encourage collaboration within the team and across departments to maximize the effectiveness of investigations, using strategies such as Operational Learning Teams.
We are seeking a collaborative investigator with experience in biologics Drug Substance manufacturing and investigations. The ideal candidate will have strong communication skills, project management experience, and the ability to manage complex investigations. Below are the qualifications we expect:
At Amgen, we are committed to both your professional and personal growth. We offer:
Ready to make a difference?
Apply now and join Amgen’s mission to change the world of biotechnology and improve the lives of patients.
Visit careers.amgen.com to apply.
Equal Opportunity Statement
Amgen is an Equal Opportunity Employer. We are committed to creating an inclusive environment and will provide reasonable accommodations to candidates with disabilities throughout the hiring process. Please contact us if you need assistance.
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