MSAT Technical Lead

Responsibilities

• Subject matter expert (SME) for DP Aseptics manufacturing.
• Process owner of DP Aseptics 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 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 DP Aseptics contract manufacturers and participation in developing supply and quality agreements.
• Lead the process technical part of a product transfer, scale up activities, validations and oversees manufacturing of DP Aseptics 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 project portfolio.
• Support SAT and Sobi's continuous improvement program for internal business processes, systems and templates.
• Key requirements
• University degree in Chemistry, Biology, Biotechnology, Pharmacy, or a related field.
• +8 years of experience of manufacturing of DP Aseptics for commercial use. Additional experience in clinical manufacturing and process development for clinical and commercial use is a plus.
• Scientific and technical background of CMC development and manufacturing of DP Aseptics
• Recognized expert in DP Aseptics manufacturing
• Demonstrable experience of working in cross functional team with ability to multitask, prioritize and be an effective decision maker
• Experience of regulatory guidelines, regulatory authorities' communication and file documentation
• Fluent in English
• Ready to be travelling up to 30% of the time.
• How to apply
• We have an ongoing selection process in this recruitment and ask you to send your application as soon as possible. Click apply and include your resume in English.
• Why Join Us?
• Here at Sobi, our mission and culture get us excited to come to work every day, but here are a few more reasons to join our team:
• Emphasis on work/life balance
• Collaborative and team-oriented environment
• Opportunities for professional growth
• Diversity and Inclusion
• Competitive compensation for your work
• Making a positive impact to help ultra-rare disease patients who are in need of life saving treatments
• We know our employees are our most valuable asset, and our culture conveys that. We offer a competitive benefits package, to support the health and happiness of our staff.
• Sobi Culture
• At Sobi, we refuse to accept the status quo. This is because we have witnessed first-hand the challenges facing those affected by rare diseases and have used this knowledge to shape our business to find new ways of helping them.
• As a specialized biopharmaceutical company, we are dedicated to rare diseases. And we see this focus as a strength.

Benefits

Additional Information

Science and Technology (SAT) is part of the Global CMC, Science & Technology Department (GCSAT). GCSAT is responsible for optimization and life cycle management of Sobi's clinical and commercial manufacturing and analytical processes from internal and 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 the internal and external manufacturing/analytical 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.

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