A company is looking for a Senior Director, Biological Analytical Development.
Key Responsibilities
Provide scientific and operational leadership for biological analytical development activities
Oversee external partners and direct reports while engaging in hands-on work such as data review and troubleshooting
Draft and review regulatory documents and contribute to agency meeting preparations
Required Qualifications, Training, and Education
At least 10 years of hands-on experience in biologics analytical development and method validation
Experience in characterization of biologics and generating data analysis reports for regulatory filings
Experience in managing contract development and addressing regulatory queries
Preferred experience leading a CMC Development Team
B.Sc. or M.Sc. in Analytical Chemistry, Biotechnology, or related field
Senior Director Of • Charleston, South Carolina, United States