Amgen Inc
B23 Manufacturing Specialist
US - California - Thousand Oaks
Sponsorship not specifiedDetected 1 day ago
Project ManagementPerformance ManagementGMPResearchLeadershipCommunicationProblem SolvingCritical ThinkingMentoringOrganizational SkillsMicrosoft Office
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16Unrated
Cap-exempt (no lottery)0
Sponsors this role0
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.
Requirements
- Doctorate degree OR
- Master's degree and 2 years of manufacturing or operations experience OR
- Bachelor's degree and 4 years of manufacturing or operations experience OR
- Associate's degree and 8 years of manufacturing or operations experience OR
- High school diploma / GED and 10 years of Manufacturing or operations experience
Nice to have
- Bachelor's degree in Life Sciences, Engineering, or a related technical discipline.
- 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
- evaluate competing hypotheses
Compensation
- 107,545.40USD -145,502.60 USD
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.
- We are all different, yet we all use our unique contributions to serve patients.
Equal opportunity
- 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, disability status, or any other basis protected by applicable law.
- Please contact us to request accommodation.
- 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.
Visa & Work Authorization
- Sponsorship for this role is not guaranteed.
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