Exciting opportunity to join an innovative biotechnology working on viral-based gene therapy and developing a non-viral, safer and more effective alternative using synthetic biology.

The Director of Analytical Development will lead an established team of impressive scientists develop, implement, and qualify assays internally and in CDMO/CROs for the Drug Substance and Drug Product manufacturing processes.

Responsibilities:

• Lead a team of scientists to develop, optimize, and qualify molecular, biochemical, physicochemical, and cell-based assays
• Lead design, implementation, and oversight of phase-appropriate Analytical Control Strategy
• Provide technical oversight and mentorship to the analytical team.
• Identify and manage external CDMO/CROs to develop and implement analytical methods
• Lead transfer of assays to CDMO/CROs

Requirements:

• 10+ years of experience in drug development or CDMO within biotechnology
• MS Degree or PhD in relevant field
• Strong leadership skills with 5+ years of management experience and at least 2 years as a director in analytical development in a cGMP environment
• Expertise in nucleic acids, virals vectors or vaccine production
• Experience with techniques such as ELISA, HPLC, ddPCR and cell based assays