Description
The Contractor Scientist will support analytical method lifecycle activities for biologics drug substance and drug product, including method development, qualification, validation, technical transfer, non-GMP and stability testing, reference standard qualification, and comparability studies. The role also involves developing scientific documents, troubleshooting analytical issues, supporting regulatory submissions and inspections, and performing routine laboratory activities. It is primarily laboratory and office-based, with occasional GMP manufacturing work, and may require shift work, weekends, and holidays.
