CMC & Manufacturing, Science and Technology Drug Substance Lead

🔥 0 minutes ago

🌲 North Carolina – Remote

🌲 North Carolina – Remote

💵 $153k - $211k / year

⏰ Full Time

🟠 Senior

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Sobi - Swedish Orphan Biovitrum AB (publ)

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

Founded 1991

🧬 Biotechnology

💊 Pharmaceuticals

⚕️ Healthcare Insurance

Biotechnology • Pharmaceuticals • Healthcare Insurance

Sobi - Swedish Orphan Biovitrum AB (publ) is a global leader in providing innovative treatments for people with rare diseases. Specializing in therapeutic areas such as haematology and immunology, Sobi is committed to improving patient access to medicines for rare and debilitating conditions. With a strong R&D pipeline, the company is actively pursuing new therapies and collaborating globally to transform patient care in areas such as haemophilia and immune thrombocytopenia. Sobi also engages in extensive sustainability and humanitarian aid programs, demonstrating a firm commitment to patient-centric care and societal contributions.

📋 Description

• Responsible for Drug Substance (DS) synthesis of a small molecule used in oral dosage forms. • Lead the technical workstreams of manufacturing process transfers from development to commercial site and between commercial sites. • Scale-up activities, process validations and oversee manufacturing of Drug Substance small molecules at external manufacturers for projects in clinical and commercial phase. • Collaborate effectively with external manufacturing partners to oversee all technical drug substance synthesis aspects (GMP and non-GMP steps). • Lead internal activities related to external manufacturing such as process change assessments, major/critical deviations, risk assessments and CAPAs. • Review and supervise design, set up, execution and documentation of DS related technical studies (CMC development as well as commercial operations), process and equipment qualifications and validations. • Write and review applicable sections in registration files, variations and market expansion.

🎯 Requirements

• University education in Chemistry, Pharmacy or similar. • 10+ years of experience of development and manufacturing of Drug Substance small molecule, non-sterile dosage forms for clinical and commercial use. • Recognized expert in synthetic organic chemistry and process R&D; experience with deuterated molecules is a plus. • Experience of working with external manufacturers. • Demonstrable experience of working in cross functional team with ability to lead functional teams, prioritize and be an effective decision maker. • Experience of regulatory guidelines (FDA & EMA), regulatory authorities communication and filing documentation. • Fluent in English, intermediate to full proficiency in Chinese is a plus.

🏖️ Benefits

• 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