MSAT Technical Lead – Drug Substance

🕒 il y a 10 jours

🌲 North Carolina – Distant

🌲 North Carolina – Remote

💵 $153 000 - $211 000 / an

⏰ Temps Plein

🟠 Senior

🧑‍💻 Développeur Full-Stack

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Sobi - Swedish Orphan Biovitrum AB (publ)

Site WebLinkedInTous les Emplois

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) for Small Molecules Drug Substance Manufacturing • Process owner of Small Molecules process 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 the setup, 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 Small Molecules contract manufacturers and participation in developing supply and quality agreements • Lead the technical part of a product transfer, scale-up activities, validations, and oversee manufacturing of Small Molecules processes at external manufacturers for Sobi projects in the 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

🎯 Exigences

• University degree in Chemistry, Biology, Biotechnology, Pharmacy, or similar • +10 years of experience in the development and manufacturing of small-molecule drug substances for clinical and commercial use • Scientific and technical background in CMC development and manufacturing of Drug Substance, Small Molecules • Significant NDA experience, preferably as a lead • Experience with regulatory guidelines, regulatory authorities communication, and file documentation • Experience overseeing external vendors such as CMOs, CDMOs, etc. • Demonstrable experience of working in a cross-functional team with the ability to multitask, prioritize, and be an effective decision maker • Fluent in English • Mandarin proficiency is helpful

🏖️ 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