SUMMARY:
This trailblazing biopharma organization is looking for a scientific leader with a strong background in Analytical Development & Gene Therapy (AAV preferred) to report to the CEO and head up the entire Analytical Development Team to support the development, optimization, qualification and execution of assays that support quality control of gene therapy products.
RESPONSIBILITIES:
- Lead a team of scientists ensuring a supportive environment for the personal and professional development of scientists while providing strategic direction for the group.
- Develop the knowledge, skills, and opportunities of staff by providing them with appropriate training, compliance, and development opportunities.
- Reports directly to the CEO; Collaborating with the CMC & Executive Leadership Team presenting results from work after critically analyzing data cross-functionally in strategic meetings
- Support the technology transfer of analytical methods to QC and assist QC with analytical method qualification and validation
- Investigate, design, and validate new scientific methodologies on highly critical, unique, and complex projects related to gene therapy analytical science
- Create and review technical reports, deviations, and change management documents to ensure projects meet company timelines & goals.
REQUIREMENTS:
- Ph.D. (or an equivalent combination of M.S. and experience) Minimum of 8-10 years of experience in the Analytical Development in the Biotechnology or pharmaceutical industry
- Strong hands-on expertise in analytical characterization methods, development, and transfer for AAV & LVV products.
- Experience with setting up & building labs for analytical development technologies/activities is a BIG plus
- Strong Leadership and communication (written & oral) skills are a MUST
- Knowledge of GMP requirements and experience in both technical and project management disciplines in CMC development and manufacturing of pharmaceutical products is preferred.
