Process Development Senior Scientist
Amgen is a leading human therapeutics company in the biotechnology industry. For more than 25 years, the company has tapped the power of scientific discovery and innovation to advance the practice of medicine.
Amgen pioneered the development of novel products based on advances in recombinant DNA and molecular biology and launched the biotechnology industry's first blockbuster medicines. Today, as a Fortune 500 company serving millions of patients, Amgen continues to be an entrepreneurial, science- driven enterprise dedicated to helping people fight serious illness.
We are seeking a:
Senior Scientist - Attribute Sciences Team Lead, Commercial Attribute Sciences
The Attribute Sciences Team Leader (ASTL) will manage all aspects of analytical strategy for a synthetic product during commercial development and lifecycle management to deliver analytical target profile, and drive product quality attribute assessment and Quality Target Product Profile. The ASTL will be responsible for ROW, PAS filings and reviews, and Pre-Approval Inspections at the Commercial Manufacturing sites. The ASTL represents the entire analytical function in the Product Development Teams and partners with representatives from key functions within Process Development, Manufacturing and Quality. The position will be located at our Cambridge, MA facility.
Doctorate degree & 2 years of Scientific experience
Master's degree & 5 years of Scientific experience
Bachelor's degree & 7 years of Scientific experience
- PhD in Chemistry or Analytical Sciences
- Deep understanding of product quality attributes control strategies
- Analytical Methods Development and Validation, troubleshooting, investigations and regulatory filing
- Experience in providing support to manufacturing of API and Drug Product and Reference Standards management
- Expert knowledge of analytical methods/technologies used in small molecule development
- Demonstrated experience working in matrix environment to support overall CMC development
- Strong communication, collaboration and team building skills
- Strong working knowledge of regulatory expectations related to analytical control strategies
- Familiarity with applicable US and worldwide regulatory requirements
- Knowledge of Validation Lifecycle Approach
- Excellent technical writing and verbal communication skills
- Experience in requisite authoring or regulatory submissions