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SeniorFull-time
Salary Range
$58,344 - $78,936 /year
This salary is estimated based on similar roles. The actual salary may vary.
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
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About Sobi
Sobi is a global specialty biopharmaceutical company focused on developing and delivering innovative therapies for patients with rare and severe diseases. Headquartered in Sweden, the company has established a strong presence in the life sciences industry, leveraging its expertise to address unmet medical needs. Founded with a commitment to improving patient outcomes, Sobi has grown into a leader in the rare disease sector, operating across multiple countries to bring life-changing treatments to those who need them most. Sobi’s main products and services include the development, manufacturing, and commercialization of specialty medicines, with a particular emphasis on hematology, immunology, and rare diseases. The company’s portfolio features therapies that target conditions such as hemophilia, immunoglobulin deficiencies, and inherited metabolic disorders. Key features of Sobi’s offerings include advanced treatment options, personalized care approaches, and robust patient support programs. The company primarily serves patients, healthcare providers, and institutions, focusing on communities affected by rare and complex conditions. Notable achievements include the successful launch of several breakthrough therapies and strategic acquisitions that have expanded Sobi’s capabilities and market reach. The company is recognized for its innovative research and patient-centric approach, positioning it as a trusted partner in the rare disease community. Sobi’s unique value proposition lies in its dedication to rare diseases, combining scientific excellence with a deep understanding of patient and caregiver needs to deliver meaningful treatments.
