Job Description
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 ...