This position will provide overall scientific and strategic leadership for 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 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.