Executive Director

Description:

We are seeking an Executive Director (flexible on title) of Process Sciences, CMC to join our small team in innovating regenerative medicine.

Responsibilities:

• Hands-on leader in an individual contributor role
• Experience in categories with complex therapies, vaccines, biologics, cell therapies.
• QTPP, Critical Quality Attributes, Potency Assays, Assay validation
• Working with FDA in CMC aspects - tenure with products through multiple stage gates in the development process.
• Working with/oversight of internal labs and external CMC partners and vendors
• Preferable is experience in therapeutic areas of inflammation, immunology, autoimmunity, oncology
• CMC Process sciences experience
• Complex vaccine and biologics experience
• Analytics background highly desirable
• BLA knowledge