Senior Director of Biological Analytics

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