Manager Analytical Development Cell & Gene Therapy
Location: Philadelphia, PA
Base: $100,000 - $150,000
SUMMARY:
This leading Biopharma is looking for a scientific leader with a strong background in Analytical Development (Gene Therapy preferred, AAV a MUST) to manage the Analytical Development Team to support the development, optimization, qualification and validation to support quality control of cell & gene therapy products.
RESPONSIBILITIES:
- Lead a team of scientists ensuring a supportive environment for the personal and professional development of scientists.
- Develop the knowledge, skills, and opportunities of staff by providing them with appropriate training, compliance, and development opportunities.
- Present 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 cell & 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 education and experience) Minimum of 3-5 years of experience in Analytical Development for the Biotechnology or pharmaceutical industry with at least three (3) years leading teams in AAV Gene Therapy.
- Strong hands-on expertise in analytical characterization methods, development, and transfer.
- Successful track record in leading CMC activities for various vectors & cell types (AAV, LVV, AVV, T cells, NK cells, CAR-T, or Stem Cells) is highly desired.
- Knowledge of GMP requirements and experience in both technical and project management disciplines in CMC development and manufacturing of pharmaceutical products is preferred.
