Job Description

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.
• 3+ years of experience in a GMP environment