MSAT Technical Lead - Drug Substance - Biologics

Full-time

Responsibilities

• Process owner of DS validation for Sobi products.
• Lead and execute MSAT projects such as manufacturing process and cost improvement as part of LCM.
• Participate in internal activities related to (external) manufacturing such as process changes, major/critical deviations, risk assessments and CAPAs.
• Issue, review and approve applicable internal and external SOP’s and manufacturing instructions.
• Review and supervise set up, execution and documentation of technical studies, qualifications and validations.
• Write and review applicable sections of the APR/PQR.
• Write and review applicable sections in registration files, variations and market expansion.
• Support in sourcing evaluation of new DS contract manufacturers and participation in developing supply and quality agreements.
• Lead the technical part ...