Senior Scientist, Drug Product Technologies
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 PhD OR PharmD OR MD [and relevant post-doc where applicable]
- OR Master’s degree and 3 years of Engineering and/or Operations experience
- OR Bachelor’s degree and 5 years of Engineering and/or Operations experience
Nice To Haves
- PhD with 2 years of industry experience.
- Background industry with development and manufacturing visual inspection experience.
- Experience with Knapp studies
- Experience in packaging and inspection equipment
- Previous experience with Pharma inspection background.
Responsibilities
- Serve as the technical SME for visual inspection and provide leadership in troubleshooting complex inspection-related issues.
- Perform offline development studies for AVI recipe development, and product quality impact assessments for product teams.
- Interface with inspection teams across Amgen manufacturing sites and communicate site capabilities, best practices, and lessons learned.
- 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
- 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
- Perform data analysis using advanced statistical/analytical techniques with a proficiency in statistical analysis software.
- 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.
- Responsibilities may include leading cross-site teams to support the above activities, providing recommendations to management.
- Assist in deviation and exception resolution and root cause analysis as needed.
- 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.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
Education Level
Ph.D. or professional degree
