MSAT Technical Lead – Drug Substance

🕒 Maio 28

🌲 North Carolina – Remoto

🌲 North Carolina – Remote

💵 $153.000 - $211.000 / ano

⏰ Tempo Integral

🟠 Sênior

🧑‍💻 Engenheiro Full-stack

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Sobi - Swedish Orphan Biovitrum AB (publ)

SiteLinkedInTodas as Vagas

1001 - 5000 funcionários

Fundada em 1991

🧬 Biotecnologia

💊 Farmacêutico

⚕️ Seguro de Saúde

Biotechnology • Pharmaceuticals • Healthcare Insurance

A Sobi é uma empresa biofarmacêutica internacional especializada em transformar a vida de pessoas com doenças raras. Oferecemos acesso sustentável a terapias inovadoras nas áreas de hematologia, imunologia e indicações especiais. Atualmente, empregamos aproximadamente 1.600 pessoas na Europa, América do Norte, Oriente Médio e Ásia. Em 2021, nosso faturamento foi de SEK 15,5 bilhões. As ações da Sobi (STO:SOBI) estão listadas na Nasdaq de Estocolmo. Você pode encontrar mais informações sobre a Sobi em sobi.com. Leia nossa política de mídias sociais em https://www.sobi.com/en/social-media-policy Você pode saber mais sobre a Sobi em https://www.youtube.com/c/sobipharma

Descrição

• 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

🎯 Requisitos

• 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

🏖️ Benefícios

• 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