Specialist Manufacturing - Downstream DS

Specialist Manufacturing Associate

What you will do

Let’s do this. Let’s change the world. In this vital role you will be part of the Manufacturing Systems team which is responsible for supporting manufacturing activities through new product introduction, new technology and equipment introduction, continual improvement projects, supporting the multiproduct facility operation program, CAPA ownership, deviation trending, and optimization/implementation of single use technologies. The position is within the drug substance supply organization in ATO Building 23 which is a dynamic environment and an important launch point for Amgen’s pipeline products.

The plant manufactures drug substance at all phases of clinical trials through commercial production. We are seeking an experienced Specialist for the Manufacturing Team to execute a variety of production and process related changes to operations in a large‑scale manufacturing plant. This Specialist will own corrective and preventative projects that are implemented into the manufacturing plant. A significant amount of time will be spent working on a collaborative team to identify appropriate corrective/preventive actions and implementing them.

Some hands‑on work on the plant floor executing runs and experiments, working with large‑scale equipment, analyzing and summarizing data findings will be required. Additional activities will include defining and documenting operation practices, ensuring documentation accurately reflects operations performed, implementing area improvements, commissioning equipment, design of experiments, effectively communicating findings and participating in operations meetings.

• Support manufacturing by providing subject‑matter expertise for drug substance downstream as process owner (PPO)
• Lead cross‑function and complex projects using project management skills
• Resolve quick issues and lead troubleshooting, including execution of function tests to troubleshoot and optimize process
• Write protocols and reports in support of validation, function testing, equipment commissioning and qualification, and change management
• Own Quality Records, such as CCMS, CAPA, and CAPA‑EV
• Apply technical process, scientific, operational, and compliance knowledge with analytical troubleshooting skills to support the implementation of new technologies into the plant
• Demonstrate strategic problem‑solving skills and champion continual improvement
• Present to inspectors on areas of expertise
• Mentor and train junior staff
• Ability to be on‑site (flexible worker)
• Available to work various shifts (day, swing, graveyard, weekends, holidays, 5x8hrs, 4x10hrs) as instructed by the production schedule to execute function‑testing and project tasks with minimal disruption to operations
• Must be able to work in a clean room environment wearing steel toe shoes, full clean room gowning, hairnet and gloves when performing all work while following GMP documents (SOPs) with strict adherence to safety and compliance

• Lead operational readiness of new technologies, equipment, or processes by applying technical process, scientific, operational, and compliance knowledge with project management skills
• Provide assessment and advice on process impact for changes
• Develop and own drug substance manufacturing processes and procedures. Draft and revise GMP manufacturing documents (SOPs, Forms). Draft and develop user requirements for new technologies.

What we expect of you

• Doctorate degree OR
• Master’s degree and 2 years of manufacturing and or operations experience OR
• Bachelor’s degree and 4 years of manufacturing and or operations experience OR
• Associate’s degree and 8 years of manufacturing and or operations experience OR
• High school diploma / GED and 10 years of manufacturing and or operations experience

• Degree in Engineering or Life Sciences
• 3 years or more experience in Drug substance GMP technical support roles, GMP manufacturing, Engineering, Process Development, or equivalent
• Technical knowledge of drug substance processing and broad understanding of related disciplinary areas
• Ability to navigate through ambiguity and…