Senior Scientist - Global Technical Operations - Analytical ( AZ15642)
This position will provide overall scientific and strategic leadership for AstraZeneca’s bio analytical operations network leading strategic analytical projects and supporting Science and Technology Excellence.
Essential Job Functions:
Key area of responsibility will be enterprise wide analytical activities in Operations, which include the following functions.
• Responsible for analytical method transfer from AstraZeneca’s Biopharmaceutical Development or Global Technical organization to commercial manufacturing sites as well as outside testing laboratories
• Responsible for developing pragmatic implementation plan, by working with stakeholders from cross functional areas
• Responsible for ensuring harmonized compliance to internal standards and policies related to analytical operations supporting third party suppliers
• Foster creative collborations between R&D, Operations and the third-party suppliers to progress the projects and coming up with win/win solutions
• Author/Review technical documents in the subject matter for regulatory submissions as needed
• Provide input and review for regulatory filings to ensure consistency in depth of content and strategic approach
• Provide forward thinking in anticipation of future needs
Knowledge and Scope
• Experience in cell culture, Immuno assay, PCR, next generation genome sequencing, biologics, residuals and impurities assay, analytical method development, transfer and method validation- Vaccine experience preferred. Leadership experience in leading global team and working with CMO is essential
• Must have significant experience with most of the following standard analytical techniques used in the biopharmaceutical industry: e.g., UV-Vis, HPLC, LC-MS, GC, FT-IR, SDS-PAGE, IEF, CE, ELISA, mass spectrometry, bioassay.
• Has a working knowledge of biosafety testing and microbiology requirements in a manufacturing environment
• Analytical method development and validation experience; knowledge of cGMP practices and ICH requirements
• Leadership experience in leading global team and working with CMO is essential
• Ability to work effectively in a team-based environment as well as cross functionally
• Ability to manage complexity and adapt to changing priorities
• Has demonstrated leadership through project team participation, internal consulting and mentoring
• Ability to make timely and defensible decisions and conclusions
• Demonstrates the ability to effectively explain complex scientific concepts to a broader, diverse audience.
• Proficient in project management and stakeholder management skills
• Experience in using Lean/continuous improvement methodology for process improvement
• MS or PhD in Biological Sciences required; 10-12 years relevant experience with a MS or 6+ years relevant experience with a Ph.D.