Quality Control Manager

Where

Cambridge, MA

What you'll be doing

Ensure QC requirements are met over life cycle of assigned biologic clinical projects. Write stability protocols and reports, batch analysis, stability and reference standard sections of regulatory submissions and retest period extensions reports. Review or revise or generate QC GMP documents (SOPs, protocols, technical reports, specifications and retest documents). Communicate project requirements and issues to quality control management and QC team. Review or analyze or trend biologic QC data generated by vendor test labs. Review or manage method transfer and method validations at contract test sites. Troubleshoot and investigate atypical results from biologic methods. Project planning or budget forecasting for assigned clinical projects. Participate in vendor audits. Oversee and manage CRO vendors.

What your background should be

4+ years laboratory experience in biotech industry with a minimum of 3 years in quality control or analytical development. Must have biologic QC experience including expertise with CMC representation and project management skills. Strong technical knowledge of biologic program QC requirements. Solid understanding of quality control CMC requirements for biologic IND, BLA and other regulatory filings. Strong working knowledge of QC and GMP compliance. Proficiency with electronic systems i.e., document system, LIMS (data management), LMS learning management system, excursions management system, JMP (statistical analysis).

Required Schooling / Training

BS or equivalent required. Masters level degree preferred.

Who is the client company

This is the largest pharmaceutical company.

If you are interested in this position, send your resume to apply@kochdavis.com