Sobi - Swedish Orphan Biovitrum AB (publ)
1001 - 5000 employés
Fondée en 1991
🧬 Biotechnologie
💊 Pharmaceutique
⚕️ Assurance santé
Biotechnology • Pharmaceuticals • Healthcare Insurance
Sobi - Swedish Orphan Biovitrum AB (publ) est un leader mondial dans la fourniture de traitements innovants pour les personnes atteintes de maladies rares. Spécialisé dans les domaines thérapeutiques tels que l'hématologie et l'immunologie, Sobi s'engage à améliorer l'accès des patients aux médicaments pour des affections rares et débilitantes. Avec un solide pipeline de R&D, l'entreprise poursuit activement de nouvelles thérapies et collabore à l'échelle mondiale pour transformer les soins aux patients dans des domaines tels que l'hémophilie et la thrombocytopénie immune. Sobi s'engage également dans des programmes étendus de durabilité et d'aide humanitaire, démontrant un engagement ferme envers des soins centrés sur le patient et les contributions sociétales.
Manufacturing, Science and Technology Lead
🕒 il y a 1 mois
🗣️🇺🇸🇬🇧 Anglais requis
🗣️🇨🇳 Chinois requis
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Sobi - Swedish Orphan Biovitrum AB (publ)
1001 - 5000 employés
Fondée en 1991
🧬 Biotechnologie
💊 Pharmaceutique
⚕️ Assurance santé
Biotechnology • Pharmaceuticals • Healthcare Insurance
Sobi - Swedish Orphan Biovitrum AB (publ) est un leader mondial dans la fourniture de traitements innovants pour les personnes atteintes de maladies rares. Spécialisé dans les domaines thérapeutiques tels que l'hématologie et l'immunologie, Sobi s'engage à améliorer l'accès des patients aux médicaments pour des affections rares et débilitantes. Avec un solide pipeline de R&D, l'entreprise poursuit activement de nouvelles thérapies et collabore à l'échelle mondiale pour transformer les soins aux patients dans des domaines tels que l'hémophilie et la thrombocytopénie immune. Sobi s'engage également dans des programmes étendus de durabilité et d'aide humanitaire, démontrant un engagement ferme envers des soins centrés sur le patient et les contributions sociétales.
Description
• Subject matter expert (SME) and process owner for Drug Product (DP) manufacturing of a small molecule used in non-sterile dosage forms • Oversee all technical drug product manufacturing aspects (fully under GMP) for a small molecule manufactured at an external manufacturer • Lead the technical workstreams of product transfers from development to commercial site and between commercial sites, scale-up activities, process validations and oversees manufacturing of Drug product with a small molecule at external manufacturers for projects in clinical and commercial phase • Lead internal activities related to external manufacturing such as process change assessments, major/critical deviations, risk assessments and CAPAs • Review and supervise set up, execution and documentation of DP related technical studies (CMC development and commercial operations), process and equipment qualifications and validations • Write and review applicable sections in registration files, variations and market expansion • Issue, review and approve applicable internal and external SOP's and external manufacturer manufacturing instructions • Contribute during set up of new analytical specifications and stability programs and review changes thereof • Support in sourcing evaluation of new Drug product small molecules, hard-gelatine capsule based alternative contract manufacturers and participation in developing supply and quality agreements • Be aware of external manufacturing technology advancements, understand and introduce new technologies and how they may be applicable to process innovation, cost or yield improvement
🎯 Exigences
• University education in Chemistry, Pharmacy or similar • +10 years of experience of development and manufacturing of oral dosage forms, drug products, with small molecules for clinical and commercial use • Recognized expert in Drug product manufacturing of hard-gelatine capsules • Scientific and technical background of CMC development and GMP-compliant manufacturing in for small molecule drug products • Demonstrable experience of working in cross functional team with ability to lead functional teams, prioritize and be an effective decision maker • Experience of working with External manufacturers • Experience of regulatory guidelines (FDA & EMA), regulatory authorities communication and filing documentation • Fluent in English, intermediate to full proficiency in Chinese is a plus.
🏖️ Avantages
• Competitive compensation for your work • Generous time off policy • Opportunity to broaden your horizons by attending popular conferences • Emphasis on work/life balance • Collaborative and team-oriented environment • Making a positive impact to help ultra-rare disease patients who are in need of life saving treatments
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