Manufacturing, Science and Technology Lead

🕒 Maio 6

🍂 Massachusetts – Remoto

🍂 Massachusetts – Remote

💵 $125.000 - $165.000 / ano

⏰ Tempo Integral

🟠 Sênior

✅ Gerente de Produto

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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) 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

🎯 Requisitos

• 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.

🏖️ 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