Director of Analytical Development
Company Summary: A small cell therapy biotech is currently seeking a driven, motivated, and multi-faceted Director to lead the analytical development team. This role is located in the Seattle, WA area. You will play a key role in providing technical and strategic leadership for a team of analytical scientists.
The Director will be responsible for:
- Leading analytical method development required for testing of intermediates, drug substances, and drug products.
- Overseeing the preparation and submission of regulatory documents related to analytical development.
- Collaborating with cross-functional teams, including research and development, manufacturing, and quality, to support the seamless progression of cell therapy programs.
- Identifying opportunities for process optimization and improvement within the analytical development function, including developing high throughput/automation testing strategies.
- Providing mentorship and guidance to team members for their professional growth.
The Director should have the following qualifications:
- Bachelor's degree with 15+ years of related experience/Master's degree with 10+ years of experience/PhD with 8+ years of experience in the proteins or cell & gene therapy field
- Previous management experience
- Technical expert in developing, qualifying, validating, and transferring methods for LCMS, flow cytometry, ELISAs, qPCR, and other cell-based assays
- Experience with regulatory filings, preferably in the cell and gene therapy space
- Ideally, the candidate should have phase 1 and pivotal trial experience or experience working on an FDA Accelerate Approval Program
Benefits:
- Health, vision, and dental benefits
- Competitive 401k employer match
- Generous PTO and commuter benefits
- Dynamic, fast-paced, and collaborative work environment
If you see yourself in this Director role and are interested, then please don't wait to apply.
