Associate Director, Analytical Development
JOB TITLE: Associate Director, Analytical Development
REPORTING RELATIONSHIP: Reports to the Senior Director, Analytical Development
DATE AVAILABLE: Immediately
The Associate Director, Analytical Development will primarily assist with the analytical development efforts of sebelipase alfa in preparation of BLA readiness and pre-IND readiness of SBC-103, and will be responsible for guiding a productive analytical research and development program for these and earlier stage programs. The Associate Director must be able to effectively write protocols and reports, and communicate results and issues within the projects to management and customers within Synageva with the highest of professional standards.
MAJOR DUTIES AND RESPONSIBILITIES:
- Provide leadership and management within Analytical Development and other groups as assigned
- Provide strategic CMC and scientific solutions to development projects
- Design, develop, validate and implement CMC-enabling analytical solutions – testing procedures, qualifications, specifications, protocols and reports.
- Ensure that the analytical biochemistry functions are completed in accordance with the Company and governmental standards of safety and quality, and that all experimental documentation is complete and timely.
- Act as the technical leader, analytical expert, and interact with external customers and internal colleagues. Will be responsible for providing liaison communication with key members within Synageva and with external CROs
- Communicate effectively in both verbal and written form on results, issues and plans. This may involve and include close interactions with customers.
- Ph.D. Analytical Chemistry or related discipline
- Five to ten years of experience in the biotech industry, direct experience in drug product development is a preferred
- At least 5 years in a management role in GMP biotech environment
- Expert in analytical technologies such as chromatography, spectroscopy, wet biochemistry principles
- Ability to lead a group of scientists for multiple development projects and provide performance appraisal, mentoring and individual development as appropriate
- Extensive knowledge and working experience in CMC development
- Experience in IND and IMPD technical submissions
- Excellent written and oral communication skills
- Strong leadership experience