The QC Manager, Contract QC provides oversight of the contract testing site(s). Provides project management and technical/operational support for commercial and clinical release, stability and characterization testing of Drug Product, Bulk Drug Substance and Antibody supporting manufacture of Antibody Drug Conjugates at Contract Testing Organizations (CTOs). The selected candidate acts as primary contact for assigned testing laboratories and assists in maintaining excellent supplier relationships and timely delivery of results to support batch release and creation of technical reports.
This is a hands-on role acting as a site subject matter expert on characterization and management of reference standards. Through coordination of in-house and contract laboratories, the QC Scientist – Protein Characterization coordinates the sourcing, manufacture, testing and release of product reference standards for antibody drug conjugate products and product intermediates, provides technical input and manages the supply of product reference standards, ensuring continuity of supply across a global network of in-house and contract GMP testing laboratories. Responsibilities include development of testing protocols, review of batch records, release of test results and control of inventory.
Provide daily Documentation support to laboratory and operation by:
- Maintenance of Standard Operating Procedures,
- Support printing control forms, issuance of controlled logbook,
- Storage and archival of control documents and maintenance of Documentation Control Rooms
- Maintenance of Veeva Documentation system,
- Issuance of batch record, control number and part number
- Provide support during regulatory inspection
- Process Document change controls and Document change orders
- Provide cross training to team members