Specialist Manufacturing - Upstream DS

Amgen • Thousand Oaks, CA

1d • $107,545 - $145,503 • Onsite

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. Amgen is advancing a broad and deep pipeline of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases, and obesity-related conditions. 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 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.

Requirements

• 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

Nice To Haves

• 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 identify and deliver on key milestones.
• Ability to advise and influence using experience and data.
• Ability to successfully communicate complex technical information with internal and external colleagues of varying organizational levels in both presentation and technical writing forms
• Ability to coach, mentor and/or cross train colleagues within core technical area.
• Team player - Ability to support process owner team by reprioritizing or readjusting projects, tasks, or responsibilities.
• Ability to drive results through leadership of cross-functional teams
• Experience leading and managing projects
• Understanding of single-use technologies
• Data analysis and/or data visualization skills
• Excellent writing skills.
• Presentation experience – presentation to leadership or auditors.
• Determines work tasks and timelines self-sufficiently – ability to navigate through ambiguity and prioritize effectively
• Proficiency in Smartsheet and excel, Trackwise, Visio, pi, SAP, Spotfire

Responsibilities

• Support manufacturing by providing subject-matter expertise for drug substance upstream 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, graves, 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.
• As Process owner: 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/own drug substance manufacturing processes and procedures.
• Draft and revise GMP manufacturing documents (SOPs, Forms).
• Draft and develop user requirements for new technologies.

Benefits

• A 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, or for field sales representatives, a sales-based incentive plan
• Stock-based long-term incentives
• Award-winning time-off plans
• Flexible work models where possible.

What This Job Offers

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