Amgen
B23 Manufacturing Specialist
US - California - Thousand Oaks
Sponsorship not specifiedDetected 1 day ago
Project ManagementPerformance ManagementGMPResearchLeadershipCommunicationProblem SolvingCritical ThinkingMentoringOrganizational SkillsMicrosoft Office
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odds of building a lasting career here
38Risky
Cap-exempt (no lottery)0
Sponsors this role85
Entry-level history0
PERM / green-card track0
Lottery odds40
Fits your clock70
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About the role
- Since 1980, we've helped pioneer the world of biotech in our fight against the world's toughest diseases.
- With our focus on four therapeutic areas -Oncology, Inflammation, General Medicine, and Rare Disease- we reach millions of patients each year.
- Amgen is advancing a broad and deep pipeline of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases, and obesity-related conditions.
Responsibilities
- Provide technical and process expertise to support deviation investigations, root cause analyses, and corrective and preventive action development.
- Partner with investigation owners, Manufacturing, Quality, Engineering, Process Development, and other cross-functional teams to evaluate events and determine appropriate investigation strategies.
- Facilitate and support structured root cause analysis activities using appropriate investigation tools and methodologies.
- Help develop CAPAs that directly address the identified root cause, are practical for the manufacturing environment, and can be effectively implemented and sustained.
- Support the collection, review, and interpretation of process data, batch documentation, equipment information, historical trends, and subject-matter expert input.
- Support and drive continuous improvement projects that improve safety, quality, compliance, process reliability, operational efficiency, and manufacturing performance.
- Partner with the Manufacturing Execution team to support operations as needed, including troubleshooting process issues, assessing operational risks, resolving execution barriers, and providing technical guidance during manufacturing activities.
- Support new product introductions and the implementation of new systems, equipment, processes, and technologies by providing process expertise, assessing operational readiness, and helping resolve implementation challenges.
- Support investigation teams in preparing for discussions with internal auditors and regulatory inspectors by ensuring technical conclusions are clear, evidence-based, and defensible.
- Build effective relationships across functions and serve as a trusted technical partner to Manufacturing, Quality, Engineering, Process Development, and other support teams.
Nice to have
- Five or more years of experience in biotechnology or pharmaceutical manufacturing, process development, engineering, technical operations, or quality assurance within a cGMP-regulated environment.
- Three or more years of experience in a production Area Lead, Specialist, Manager, or comparable leadership role with responsibility for leading teams, projects, programs, or resource allocation.
- Strong knowledge of biotechnology manufacturing processes, equipment, batch documentation, quality systems, and technical elements associated with biological or chemical processing.
- Experience supporting complex deviation investigations, structured root cause analyses, and the development or evaluation of corrective and preventive actions.
- Working knowledge of investigation and root cause analysis methodologies, including fishbone analysis, fault-tree analysis, five whys, process mapping, barrier analysis, or similar tools.
- Demonstrated ability to analyze process data, batch records, equipment information, historical events, and technical documentation
- Experience supporting manufacturing execution, continuous improvement initiatives, plant start-up activities, new product introductions, or the implementation of new systems, equipment, and technologies.
- Previous experience managing employees or demonstrated leadership experience in coaching, mentoring, team development, performance management, and conflict resolution.
Compensation
- 107,545.40USD -145,502.60 USD Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics.
Company info
- Career Category Manufacturing Job Description Join Amgen's Mission of Serving Patients At Amgen, if you feel like you're part of something bigger, it's because you are.
- If you have a passion for challenges and the opportunities that lay within them, you'll thrive as part of the Amgen team.
- What We Expect of You We are all different, yet we all use our unique contributions to serve patients.
Visa & Work Authorization
- Sponsorship Sponsorship for this role is not guaranteed.
This listing is sourced directly from Amgen's careers page and normalized into a canonical job model.