MSAT Technical Lead - Drug Substance - Biologics

Company Description

At Sobi, the work we do every day redefines the standards of care and transform the lives of people living with rare diseases.

At Sobi, the work we do every day redefines the standards of care and transform the lives of people living with rare diseases.
As a diverse team of entrepreneurial people, we are passionate about our growth journey towards becoming a global leader, making a difference for rare disease patients, moving quickly and always challenging the status quo.
We are committed to an inclusive, sustainable and flexible workplace that fosters growth and development.

Science and Technology (SAT) is part of the Global CMC, Science & Technology Department (GCSAT).
GCSAT is a growing organization, responsible for optimization and life cycle management of Sobi’s clinical and commercial manufacturing and analytical processes in our external network. SAT ensures compliant, reliable, cost effective and sustainable manufacturing and testing of our products now and in future. The SAT team holds the senior scientific and technical knowledge for the manufacturing and analytical testing of Sobi’s clinical and commercial products and is responsible for always keeping processes in a validated stage.
The Technical Lead is pivotal in ensuring technical excellence, regulatory compliance, and the continuous improvement of manufacturing processes. The incumbent will drive cross-functional collaboration to support the launch and lifecycle management of products, technology transfers, and the implementation of innovative methodologies.

• Subject matter expert (SME) for DS Biologics manufacturing.
• Process owner of DS Biologics validation for Sobi products.
• Lead and execute MSAT projects such as manufacturing process and cost improvement as part of life-cycle management (LCM).
• Participate in and lead 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, as well as answer Health authorities requests and questions.
• Support in sourcing evaluation of new DS Biologics contract manufacturers and participation in developing supply and quality agreements.
• Lead the process components of the product transfer, scale up activities, validations and oversee manufacturing of DS Biologics processes at external manufacturers for Sobi projects in clinical and commercial phase.
• Be aware of external pharmaceutical manufacturing technology advancements, understand and introduce new technologies and how they may be applicable to process innovation, cost or yield improvement
• Represent SAT in product governance teams as needed, including potentially coordinating the oversight and escalation of DS, DP and Analytical project portfolio.
• Support SAT and Sobi’s continuous improvement program for internal business processes, systems and templates.

• University education in Biology, Biotechnology, Pharmacy or similar.
• +10 years of experience of manufacturing of DS Biologics for commercial use. Additional experience in clinical manufacturing and process development for clinical and commercial use is a plus.
• Strong background in Upstream Manufacturing (including Cell banking and new working cell bank implementation). Mammalian Cell culture mainly and bacterial fermentation a plus.
• Strong understanding of scale down models and their qualification a plus.
• Scientific and technical background of CMC development, product launch is a plus.
• Experience of regulatory guidelines, and regulatory authorities’ communication.
• Demonstrable experience of working in cross functional team with ability to multitask, prioritize and be an effective decision maker
• Ability to thrive in new, unstructured environments and influence without authority.
• Ability to act…