Specialist Manufacturing Drug Substance

Amgen • Juncos, PR

1d

About The Position

Join Amgen’s Mission of Serving Patients At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do. 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. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career. SPECIALIST MANUFACTURING DRUG SUBSTANCE What you will do Let’s do this. Let’s change the world. In this vital role you will lead the optimization of critical manufacturing processes, driving innovation and quality that directly impacts the lives of patients around the globe.

Requirements

• Doctorate degree
• Master’s degree and 2 years of Manufacturing/Quality Support experience
• Bachelor’s degree and 4 years of Manufacturing/ Quality Support experience
• Associate’s degree and 8 years of Manufacturing/ Quality Support experience
• High school diploma / GED and 10 years of Manufacturing/ Quality Support experience

Nice To Haves

• Educational background in Life Sciences and/or Engineering.
• In-depth experience of bio-processing unit operations
• Knowledge in Root Cause Analysis methodologies (Fishbone, Six Boxes, 5 Why’s, Kepner Tregoe)
• Familiar with Lean Manufacturing Practices
• Ability to communicate and collaborate with technical and management staff within manufacturing, process development, and quality.
• Proficiency in GDP (Good Documentation Practices) on a regulated environment
• Knowledge in systems/Tools: Trackwise, VEEVA, MES, Smart Sheet, ChatGPT, Copilot, Power BI, Spotfire, CDOCS, and process monitoring platforms
• Strong Technical Writing/presentation abilities, and excellent written/verbal communication skills in English and Spanish

Responsibilities

• Serve as the subject matter expert for specific manufacturing processes, equipment, systems or deviations & CAPAs management, providing technical leadership across the site.
• Own and maintain SOPs, batch records, deviations, CAPAs, CAPAs EVs and technical documentation to ensure compliance with cGMP and regulatory standards.
• Lead troubleshooting efforts for complex process or equipment issues, conducting root cause analyses and implementing preventive measures.
• Monitor manufacturing data and key performance indicators metrics to identify trends, risks, and opportunities for improvement.
• Drive continuous improvement by exploring new technologies, digital tools, and best practices to enhance process efficiency and reliability.
• Provide formal training and mentorship to team members on new or complex manufacturing processes, systems, deviations, and CAPAs/EVs management.
• Represent Manufacturing in cross-functional meetings, audits, and investigations, translating technical insights into actionable recommendations.
• Lead or support change controls, deviations, and CAPAs to ensure consistent product quality and regulatory compliance.
• Plan and manage projects related to process optimization, ensuring timely execution and alignment with quality standards.
• Support a culture of accountability, safety, and performance by modeling high standards and reinforcing compliance expectations.
• Guide team members through troubleshooting and process improvement efforts, sharing best practices and lessons learned.
• Stay current on industry trends and technical advancements through continuous learning and external engagement.

Benefits

• A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental & vision coverage, and life & disability insurance
• A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
• Stock-based long-term incentives
• Award-winning time-off plans and an annual site shutdown
• Flexible work models, including remote work arrangements, where possible

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: No Education Listed