Specialist Manufacturing Downstream DS - Thousand Oaks CA

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.

Responsibilities

• 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

Minimum Education Required

• 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

Additional Qualifications/Responsibilities

• Basic Qualifications: 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
• Preferred Qualifications: 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

What You Can Expect From Us

• As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way.
• The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.
• In Addition To The Base Salary, Amgen Offers a Total Rewards Plan, Based On Eligibility, Comprising Of Health And Welfare Plans For Staff And Eligible Dependents, Financial Plans With Opportunities To Save Towards Retirement Or Other Goals, Work/life Balance, And Career Development Opportunities That May Include 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.