Senior Bioprocess Engineer
Core
Lead clinical and commercial biopharmaceutical manufacturing operations, technology transfer, and process improvements for drug substance production.
Role type
Senior Bioprocess Engineer (Manufacturing)
Builds
Biopharmaceutical drug substance products
Domain
Biopharmaceutical manufacturing
Required skills
Biopharmaceutical process development, Technology transfer, Process optimization, GxP regulations, Data analysis, Scale-up execution, Deviation management, Change management, Process monitoring, Technical training
Preferred skills
Large scale cell culture, Bioseparations, Purification technologies, Analytical technologies, Matrix leadership, Critical thinking
Technologies
KLA, Upstream/downstream processing equipment
Responsibilities
Provide real-time process monitoring and technical oversight for 24-7 manufacturing operations; Design and execute technical studies and protocols for technology transfer and scale-up; Lead introduction and scale-up of primary manufacturing processes; Investigate and resolve process issues to maintain control limits; Provide technical training to production staff; Manage relationships with cross-functional stakeholders and global teams.
Seniority
Senior, hands-on IC with matrix leadership responsibilities