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.
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.
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:
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Process owner of DS validation for Sobi products.
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Lead and execute MSAT projects such as manufacturing process and cost improvement as part of LCM.
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Participate in internal activities related to (external) manufacturing such as process changes, major/critical deviations, risk assessments and CAPAs.
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Issue, review and approve applicable internal and external SOP’s and manufacturing instructions.
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Review and supervise set up, execution and documentation of technical studies, qualifications and validations.
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Write and review applicable sections of the APR/PQR.
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Write and review applicable sections in registration files, variations and market expansion.
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Support in sourcing evaluation of new DS contract manufacturers and participation in developing supply and quality agreements.
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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.
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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
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University education in Chemistry, Biology, Biotechnology, Pharmacy or similar.
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+5 years of experience of development and manufacturing of Drug Substance for clinical and commercial use
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Scientific and technical background of CMC development and manufacturing of Drug Substance.
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Recognized expert in drug substance manufacturing
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Demonstrable experience of working in cross functional team with ability to multi task, prioritize and be an effective decision maker
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Experience of regulatory guidelines, regulatory authorities communication and file documentation
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Fluent in English
Additional Information
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:
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Emphasis on work/life balance
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Collaborative and team-oriented environment
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Opportunities for professional growth
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Diversity and Inclusion
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Competitive compensation for your work
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Making a positive impact to help ultra-rare disease patients who are in need of life saving treatments
We are a global company with over 1,900 employees in more than 30 countries and are committed to the societies where we operate. With a deeply skilled management team directing our day-to-day wins, and a Board with a stellar track record, we’re ready to take on the world’s diseases, ailments and adversity. Our people believe they have the power to make a positive impact in others’ lives because that’s exactly what we do here. If you’re seeking a career that taps into your talents in a way that makes the world a better, healthier place, we just may have a job for you.
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.
