MSAT Technical Lead - Drug Substance - Biologics

MSAT Technical Lead - Drug Substance - Biologics

Sobi

Basel, Switzerland

Job Description

Manufacturing Science and Technology (MSAT) is part of the Global CMC, Science & Technology Department (GCSAT). GCSAT is responsible for optimization and life cycle management of Sobis clinical and commercial manufacturing processes from internal and external network. MSAT ensures compliant, reliable, cost effective and sustainable manufacturing of our products now and in future. The MSAT team holds the senior scientific and technical knowledge for the manufacturing of Sobis clinical and commercial products and is responsible for always keeping the internal and external manufacturing processes in a validated stage.

Main 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 of a product transfer, scale up activities, validations and oversees manufacturing of DS processes at external manufacturers for Sobi projects in clinical and commercial phase.
• Be aware of external biopharmaceutical manufacturing technology advancements, understand and introduce new technologies and how they may be applicable to process innovation, cost or yield improvement

Qualifications

• University education in Chemistry, Biology, Biotechnology, Pharmacy or similar.
• +5 years of experience of development and manufacturing of Drug Substance for clinical and commercial use
• Scientific and technical background of CMC development and manufacturing of Drug Substance.
• Recognized expert in drug substance manufacturing
• Demonstrable experience of working in cross functional team with ability to multi task, prioritize and be an effective decision maker
• Experience of regulatory guidelines, regulatory authorities communication and file documentation
• Fluent in English