Senior Process Development Engineer

Career Category

Engineering

Job Description

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.

Senior Process Development Engineer

What you will do

Let’s do this! Let’s change the world!

As part of Amgen’s Process Development organization, Drug Product Technologies (DPT) is seeking a highly motivated Senior Engineer to provide process development support to Amgen’s clinical and commercial sterile fill-finish manufacturing plant in Thousand Oaks, CA (ATO). The candidate will play a key role in bringing a wide variety of high-quality clinical and licensed drug products to patients through demonstrated excellence in aseptic processing, technology transfer, process characterization, process validation and continuous process verification. Periodic shift work or on call work is required.

Key Responsibilities:

New Product Introductions

• Leads or supports new product introductions and lifecycle changes into Amgen Thousand Oaks drug product manufacturing facility as the Process Development lead by integrating products’ process design and requirements with the site’s procedures and capabilities. Serves as the Process Development SME for these products following completion of the tech transfer.

• Collaborates with multiple plant functions to ensure the aseptic fill finish equipment and procedures that constitute the DP platform processes are fully characterized to enable efficient and successful tech transfers of Amgen’s clinical & commercial product portfolio.

• Acts as point contact to provide knowledge of clinical and commercial manufacturing site process capabilities and practices.

• Supports make-a-batch exercises to determine facility fit and identify gaps.

• Designs, implements and documents off-line and on-site DP characterization studies.

• Designs, plans, and provides floor support to engineering, machinability, and process performance qualifications (PPQ) runs required to ensure successful product commercialization.

• Author and/or own high-quality process technology transfer and other technical documents.

Process Validation & Regulatory Support

• Development of validation plans and supports execution of PPQs for commercial manufacturing. Authors, and reviews process validation protocols, assessments and reports within Amgen’s quality systems.

• Ensure site’s process validation business process adheres to global regulatory agency standards, Amgen’s quality requirements, other site policies and procedures, including safety and training.

• Be a key contributor to regulatory filings as part of the NPI process throughout the authoring, review and submission process and be responsible for response to regulator questions as required and support pre-Licensure & GMP inspections in the plant.

Manufacturing Support

• Provide front line and independent process development expertise for clinical and commercial drug product manufacturing operations during sterile processing, process characterization, tech transfer, process validation, and on-going commercial manufacturing.

• Lead or assist in process related deviations, exception resolution and root cause analysis to ensure smooth operations & continued supply. Solve issues with drug product processing technologies and equipment.

• Embodies the use of science-based methodologies to rigorously drive to true root cause, such that decisions are both timely, and supported by clear Claims / Reasons / Evidence-based reasoning, ensuring patient safety.

• Conducts risk assessment for drug product operations and propose / implement appropriate Corrective / Preventative Actions (CAPA) for continuous improvement.

• Collaborate with manufacturing as well as all support functions such as engineering, quality, and drug product