Teams at CSBio

Supervises cGMP peptide manufacturing across SPPS, purification, lyophilization, and packaging operations. Leads production staff, scheduling, campaign execution, equipment qualification, batch records, investigations, process improvements, validation, tech transfer, and regulatory inspection support. The role requires hands-on peptide manufacturing expertise, compliance with FDA cGMP and data integrity standards, MES/eBR familiarity, and the ability to troubleshoot manufacturing issues while developing a high-performing team.

Support and oversee pharmaceutical quality systems, including deviations, CAPAs, document control, training, complaints, validation, risk assessments, and regulatory compliance. Review and approve quality and validation documentation, manage GxP asset validation plans, support recalls, drive continuous improvement, and mentor staff. The role requires cross-functional collaboration with Operations, Manufacturing, Quality Control, and Validation teams in a fast-paced peptide manufacturing environment.