Amgen
Specialist Manufacturing - Drug Product (DP) Operations
Amgen, Thousand Oaks, California, United States, 91362
Specialist Manufacturing - Drug Product (DP) Operations
Join Amgen’s mission of serving patients. At Amgen, we help pioneer the world of biotech, addressing serious illnesses. Our focus on four therapeutic areas—Oncology, Inflammation, General Medicine, and Rare Disease—reaches millions of patients each year. As part of the Amgen team, you will help research, manufacture, and deliver innovative medicines to improve patient lives.
Location Thousand Oaks, CA
What You Will Do You will partner with cross‑functional teams—including Engineering, Quality, Process Development, and Operations—to implement process improvements, support new technology introductions, and maintain robust GMP manufacturing performance. Your work will directly contribute to Amgen’s ability to deliver life‑changing therapies worldwide.
Key Responsibilities
Document and Process Management – Initiate, revise, and approve controlled manufacturing documents within Amgen’s electronic document management system (CDOCs). Serve as document author, owner, reviewer, or data verifier, ensuring accuracy and compliance with current GMP and Amgen standards.
Process Implementation and Project Execution – Support implementation of new processes, equipment, and major initiatives within Drug Product operations. Collaborate with Capital, Engineering, Process Development, Quality, and other functions to define requirements and achieve operational readiness.
Operational Performance and Data Analytics – Analyze manufacturing data and performance metrics to identify trends, deviations, and opportunities for improvement. Develop and implement data‑driven solutions to improve yield, reliability, and compliance.
Deviation and CAPA Management – Support timely investigation and resolution of manufacturing deviations. Participate in root cause analyses (RCA) and human performance evaluations. Contribute to the development and implementation of effective corrective and preventive actions (CAPAs) and monitor CAPA effectiveness.
Validation and Process Control – Assist in developing and implementing process validation protocols and reports. Collect, analyze, and interpret validation and process monitoring data to ensure process robustness and compliance.
Change Control and Continuous Improvement – Support change control activities to ensure GMP, regulatory, and operational compliance. Evaluate and justify process or equipment changes and assist with project execution. Participate in continuous improvement and operational excellence initiatives to enhance safety, quality, and efficiency.
Basic Qualifications
Doctorate degree OR
Master’s degree and 2 years of Manufacturing support experience OR
Bachelor’s degree and 4 years of Manufacturing support experience OR
Associate’s degree and 8 years of Manufacturing support experience OR
High school diploma / GED and 10 years of Manufacturing support experience
Preferred Qualifications
Advanced degree (Master’s or Ph.D.) in Engineering, Biotechnology, or related field
Experience in aseptic Drug Product or biologics manufacturing
Knowledge of process validation, deviation management, and change control
Strong analytical and problem‑solving skills with experience using data visualization tools (Spotfire, JMP, Excel)
Excellent written and verbal communication skills and ability to collaborate across functions
Competencies for Success
Operational Excellence – Demonstrates attention to detail, prioritizes quality and compliance, and drives process improvements.
Technical Expertise – Applies technical knowledge to evaluate, troubleshoot, and optimize manufacturing processes.
Collaboration – Builds strong cross‑functional relationships and fosters teamwork across disciplines.
Accountability – Takes ownership of deliverables and ensures timely completion of commitments.
Continuous Improvement – Identifies and implements opportunities to enhance manufacturing performance and reliability.
What You Can Expect From Us Amgen offers a competitive benefits package, opportunities for career development, and a culture that values collaboration and innovation. The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on experience and qualifications.
Benefits Overview
Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts.
A discretionary annual bonus program.
Stock‑based long‑term incentives.
Award‑winning time‑off plans.
Flexible work models where possible.
Application Deadline Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.
Sponsorship Sponsorship for this role is not guaranteed.
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.
Accommodations We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process. Please contact us to request accommodation.
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Location Thousand Oaks, CA
What You Will Do You will partner with cross‑functional teams—including Engineering, Quality, Process Development, and Operations—to implement process improvements, support new technology introductions, and maintain robust GMP manufacturing performance. Your work will directly contribute to Amgen’s ability to deliver life‑changing therapies worldwide.
Key Responsibilities
Document and Process Management – Initiate, revise, and approve controlled manufacturing documents within Amgen’s electronic document management system (CDOCs). Serve as document author, owner, reviewer, or data verifier, ensuring accuracy and compliance with current GMP and Amgen standards.
Process Implementation and Project Execution – Support implementation of new processes, equipment, and major initiatives within Drug Product operations. Collaborate with Capital, Engineering, Process Development, Quality, and other functions to define requirements and achieve operational readiness.
Operational Performance and Data Analytics – Analyze manufacturing data and performance metrics to identify trends, deviations, and opportunities for improvement. Develop and implement data‑driven solutions to improve yield, reliability, and compliance.
Deviation and CAPA Management – Support timely investigation and resolution of manufacturing deviations. Participate in root cause analyses (RCA) and human performance evaluations. Contribute to the development and implementation of effective corrective and preventive actions (CAPAs) and monitor CAPA effectiveness.
Validation and Process Control – Assist in developing and implementing process validation protocols and reports. Collect, analyze, and interpret validation and process monitoring data to ensure process robustness and compliance.
Change Control and Continuous Improvement – Support change control activities to ensure GMP, regulatory, and operational compliance. Evaluate and justify process or equipment changes and assist with project execution. Participate in continuous improvement and operational excellence initiatives to enhance safety, quality, and efficiency.
Basic Qualifications
Doctorate degree OR
Master’s degree and 2 years of Manufacturing support experience OR
Bachelor’s degree and 4 years of Manufacturing support experience OR
Associate’s degree and 8 years of Manufacturing support experience OR
High school diploma / GED and 10 years of Manufacturing support experience
Preferred Qualifications
Advanced degree (Master’s or Ph.D.) in Engineering, Biotechnology, or related field
Experience in aseptic Drug Product or biologics manufacturing
Knowledge of process validation, deviation management, and change control
Strong analytical and problem‑solving skills with experience using data visualization tools (Spotfire, JMP, Excel)
Excellent written and verbal communication skills and ability to collaborate across functions
Competencies for Success
Operational Excellence – Demonstrates attention to detail, prioritizes quality and compliance, and drives process improvements.
Technical Expertise – Applies technical knowledge to evaluate, troubleshoot, and optimize manufacturing processes.
Collaboration – Builds strong cross‑functional relationships and fosters teamwork across disciplines.
Accountability – Takes ownership of deliverables and ensures timely completion of commitments.
Continuous Improvement – Identifies and implements opportunities to enhance manufacturing performance and reliability.
What You Can Expect From Us Amgen offers a competitive benefits package, opportunities for career development, and a culture that values collaboration and innovation. The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on experience and qualifications.
Benefits Overview
Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts.
A discretionary annual bonus program.
Stock‑based long‑term incentives.
Award‑winning time‑off plans.
Flexible work models where possible.
Application Deadline Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.
Sponsorship Sponsorship for this role is not guaranteed.
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.
Accommodations We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process. Please contact us to request accommodation.
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