Amgen Senior Scientist - Attribute Sciences Team Lead, Commercial Attribute Sciences in Cambridge, Massachusetts
The Attribute Sciences Team Leader (ASTL) will manage and deliver all aspects of analytical strategy for a bio-therapeutic 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 is an individual contributor with a leadership role in partnering with representatives from key functions within Process Development, Manufacturing and Quality.
The position will be located at our Cambridge, MA facility.
Doctorate degree and 2 years scientific experience
Master's degree and 5 years scientific experience
Bachelor's degree and 7 years scientific experience
PhD in Chemistry, Analytical Sciences or Life Sciences
5+ years scientific experience within the Biotech industry
Analytical method development, validation, transfer, trouble-shooting, problem solving, investigations and regulatory filing
Knowledge of Validation Lifecycle Approach
Deep understanding of product quality attributes control strategies
Strong working knowledge of regulatory expectations related to analytical control strategies
Familiarity with applicable US and worldwide regulatory requirements
Experience in requisite authoring or regulatory submissions
Expert knowledge of analytical methods/technologies used in biopharmaceutical product development
Experience in providing support to manufacturing of API and Drug Product and Reference Standards management
Excellent technical writing and verbal communication skills
Strong communication, collaboration and team building skills with a demonstrated ability to lead and work within a matrixed organization and to work collaboratively within multidisciplinary teams. Demonstrated experience working in matrix environment to support overall CMC development
Experience in data analysis, statistical analysis, and in setting acceptance criteria in support of process development, process/method transfers, and comparability studies
Computer literacy (Windows environment: Word, Excel, Power Point, One Note, and MS Project)
Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.