Job Title: Upstream Process Development Manager
About the Role
We are seeking an experienced Upstream Process Development Manager to join our team. The ideal candidate will have a strong background in upstream cell culture, manufacturing, and science activities, as well as late-stage development.
Key Responsibilities
* Oversee outsourced upstream process and cell bank related activities, including technical development, approval, and life cycle management of Biosimilar drug substance production;
* Provide scientific and technical oversight for upstream process development activities at drug substance manufacturing CDMO;
* Define technical development that follows Quality by Design principles and relevant regulatory requirements;
* Assume a leading role in planning and executing USP technology transfer activities;
* Review and approve external technical development protocols/reports;
Requirements
* Minimum Master's or Bachelor's degree in life sciences or engineering;
* Minimum 10 years relevant experience in Biotech Industry with demonstrated track record in Upstream processing for biologics;
* Strong technical expertise across Upstream development spectrum;
* Technical leadership and influencing skills;
* Fluency in English;
Seniority Level
Mid-Senior level
Employment Type
Full-time
Job Function
Management and Science
Industries
Pharmaceutical Manufacturing and Biotechnology Research