The Analytical Development Manager will support the development of analytical methods and programs for analytical development.
Qualifications
ESSENTIALS OF THE JOB:
Responsible for developing new or improved analytical development methods and processes
Lead project teams and direct reports
Independently design, execute, analyze studies, under the direction of senior management
Remain current on developments in the field and relevant guidance (ICH and USP)
Mentor scientists as they need assistance in experimental design, make recommendations to management, analyze project goals and criteria to ensure they are scientifically sound and meet the business needs of all key stakeholders
Manage stakeholders and interface with departments such as PD, Manufacturing, RA, Quality, as appropriate
Demonstrate strong technical expertise and provide business centered, innovative solutions to process improvement and development initiatives
Excellent written and oral communication skills
Statistical analysis for analysis and interpretation of data
Serve as a technical expert for analytical development and validation or analytical methods
Education Requirements:
Master's degree or PhD in biochemistry, chemical engineering, biophysics, biology or related discipline
Bachelor's degree and 12 years of biologics or analytical development experience
Experience Requirements:
10+ years of experience developing biologics processes or analytics and designing protocols.