Senior Scientist, Drug Product Technologies - Thousand Oaks, CA

Military Spouse Corporate Career Network • Thousand Oaks, CA

19h • Onsite

About The Position

At Amgen, we are driven by our shared mission to serve patients living with serious illnesses. Since 1980, we have pioneered the biotech industry in our fight against the world's toughest diseases, focusing on Oncology, Inflammation, General Medicine, and Rare Disease. We are advancing a broad pipeline of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases, and obesity. As a member of the Amgen team, you will help make a lasting impact on patients' lives by researching, manufacturing, and delivering innovative medicines. Our award-winning culture is collaborative, innovative, and science-based. We are seeking a Senior Scientist for our Drug Product Technologies Group in Thousand Oaks, CA. This group is responsible for late-stage drug product formulation and fill/finish process development for various biological modalities (large molecule, RNA, virus). The Sr. Scientist will provide technical and project leadership, integrating information from multi-functional teams to ensure success through the commercialization process. The candidate will stay ahead of industry and scientific developments to foster innovation and meet future business needs. The Sr. Scientist will leverage advanced AI technologies, including generative AI, large language models (LLMs), and in silico modeling, to drive innovation and accelerate research, development, and testing processes. The Sr. Scientist will support Amgen’s biologics drug product and process design, commercialization, and lifecycle management, working closely with engineers and scientists. The role operates in a fast-paced, matrixed environment, requiring collaboration within DPT and cross-functionally to develop lean study designs, create tools for data acquisition, analysis, and modeling, and improve operational efficiency. A successful candidate will work independently, manage work packages, and communicate effectively. They will thrive in a multi-functional team, collaborating with colleagues and partner organizations. They will be driven to find efficient approaches to solve problems and deliver value-adding, agile solutions. This position requires up to 10% travel.

Requirements

• Doctorate degree PhD OR PharmD OR MD [and relevant post-doc where applicable] OR Master’s degree and 3 years of Scientific experience OR Bachelor’s degree and 5 years of Scientific experience

Nice To Haves

• Experience that includes elements of new product development, aseptic processing, filling, manual / automated visual inspection, process characterization, equipment design and implementation, technical transfers to global manufacturing sites, statistical process control (SPC), and statistical design and analysis of experiments.
• Proficiency in digital technologies and automation systems related to aseptic processing and visual inspection or filling operations, including experience with data analytics, process monitoring tools, and digital process control systems.
• Comfort with data science principles, coding, process automation, statistical techniques, deep learning, machine learning, artificial intelligence, robotics, machine vision, optics and additive manufacturing
• Advanced degree in Chemical Engineering, Biomedical Engineering, Biotechnology, Pharmaceutics or related field or Statistics degree with experience in pharmaceutical development and manufacturing.
• Knowledge of inspection processes, vision systems, Knapp studies, inspection equipment qualifications, manual inspection qualifications
• Strong skills in applying fundamental engineering and scientific principles to the design and implementation of Inspection processes
• Experience in cGMP manufacturing environment, knowledge of cGMPs and other worldwide regulatory requirements, and experience in regulatory inspections.
• Project management skills, including the ability to manage numerous projects and evaluate project resource requirements.
• Demonstrated ability in providing leadership to cross-functional teams to advance complex projects to completion and influencing decisions
• Excellent oral and written communications skills

Responsibilities

• Plan, design, execute, and document laboratory studies related to formulation, aseptic processing, visual inspection and fill/finish process development in support of product commercialization and life cycle management
• Apply basic science/engineering skills and first principles modeling to solve technical problems
• Participate in Drug Product Commercialization Teams responsible for conducting process development on pipeline products, as well as, supporting commercial products in lifecycle management.
• Perform data analysis using advanced statistical/analytical techniques with a proficiency in statistical analysis software.
• Leverage advanced AI technologies, including generative AI, large language models (LLMs), and in silico modeling, to drive innovation and accelerate research, development, and testing processes
• Provide support, as needed, to clinical and commercial fill/finish manufacturing operations through process capability analysis, troubleshooting, root cause analysis, and product impact assessments for non-conformance investigations and process changes/improvements.
• Author and review guideline documents, technical protocols, reports, product impact assessments, and regulatory sections in support of IND and marketing application submissions.
• Deliver progress reports and presentations to ensure management awareness and engagement of the current status, advancement, and future program functional needs.
• Ability to travel domestically and internationally up to 10% of the time.
• Conducts risk assessment for inspection operations and propose / implement appropriate CAPA.
• Identifies and implements operational opportunities for current and new inspection operations.
• Responsibilities may include leading cross-site teams to support the above activities, providing recommendations to management.
• Development of Validation Plans, IOQs and PQs
• Ensure that inspection operations meet applicable quality requirements applicable laws FDA, EU & International Standards
• Assist in the development of any existing Validation program to ensure continued compliance to the necessary regulations.
• Recommendations to Site Validation Guidance Documents
• Assist in deviation and exception resolution and root cause analysis.
• Participate as required in project activities.
• Coordinates and organizes resources needed to complete tasks

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