Sr Engineer

Amgen • Thousand Oaks, CA

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

Requirements

• Doctorate degree OR Master's degree and 2 years of Engineering experience OR Bachelor's degree and 4 years of Engineering experience OR Associate's degree and 8 years of Engineering experience OR High School Diploma/GED and 10 years of Engineering experience.

Nice To Haves

• Advanced degree in engineering, biotechnology, life sciences or related subject area.
• 2+ years experience in the pharmaceutical or biotechnology industry that includes elements of process development, process characterization, and technical transfers to manufacturing sites.
• Advanced knowledge of biopharmaceutical manufacturing and business processes, and experience supporting GMP manufacturing operations.
• Knowledge of, and hands-on experience with various drug product technologies related to fill-finish process (freeze-thaw, filtration, filling, isolators, visual inspection operations etc.).
• Ability to lead innovation, collaborate in a multi-functional team, and act on dynamic information at a rapid pace.
• Ability to independently design and complete characterization studies, author characterization protocols, process transfer documents, and technical reports.
• Proficiency in technical problem solving, critical thinking, and the delivery of technical solutions with limited oversight.
• Capable of organizing and communicating technical concepts to enable business decisions.
• Demonstrated skills in leading diverse multi-functional projects.

Responsibilities

• Provide technical leadership to Amgen’s parenteral drug product process design and commercialization.
• Lead off-line process characterization activities and work with global technology transfer team to transfer the process to clinical/ commercial fill finish lines with the aim of reducing or eliminating the onsite characterization work required.
• Play a meaningful role in developing business cases for using the pilot plant capabilities further to serve the network, support development of silico models to enable rapid, robust, process development.
• Operate and trouble shoot filling equipment for characterization, special studies, and/or material generation to support the Amgen network.
• Design, implement and document technical data packages related to drug product process design, development and characterization.
• Meticulous review of protocols, and study design, to streamline execution and ensure successful implementation.
• Support development of models and other data analytics tools for rapid process development and tech transfer.
• Drive innovations in drug product process characterization and reduce pilot plant and clinical/ commercial GMP line time required for successful technology transfers and NPIs.
• Apply fundamental scientific (biochemistry, biophysics, statistics, etc.) and engineering principles to resolve issues, improve and develop new processes and evaluate effects of equipment changes, scale, and implementation of new raw materials.
• Serve as an authority on manufacturing technologies (e.g. filling, automated visual inspection) and work with global multi-functional teams to develop and improve shared standard methodologies and technical advancements across Amgen clinical and commercial fill-finish plants.
• Apply strong written and verbal communicational skills. Author technical protocols, reports and present findings and project status.
• Contribute to and maintain a strong culture of safety and compliance in the plant.

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: Senior
• Education Level: Ph.D. or professional degree