MSAT Technical Lead – Drug Substance, Senior Manager

🔥 0 minutes ago

🔔 Pennsylvania – Remote

🔔 Pennsylvania – Remote

💵 $140k - $165k / year

⏰ Full Time

🟠 Senior

🧑‍💻 Full-stack Engineer

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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

• 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.

🎯 Requirements

• University degree in Chemistry, Biology, Biotechnology, Pharmacy, or similar • 6+ years of experience in the development and manufacturing of small-molecule drug substances for clinical and commercial use • 3+ years of experience in a commercial setting, leading the technical pieces of product transfer, scale-up, and validation • Experience reviewing applicable sections of the APR/PQR • Scientific and technical background in CMC development and manufacturing of drug substances, small molecules • Experience with regulatory guidelines, regulatory authorities communication, and file documentation • Experience overseeing external vendors such as CMOs, CDMOs, etc. • Demonstrable experience working in a cross-functional team with the ability to multitask, prioritize, and be an effective decision-maker.

🏖️ Benefits

• A competitive 401(k) match to support your financial future. • Tuition and wellness reimbursements to invest in your personal and professional growth. • A comprehensive medical, dental, and vision package to prioritize your health and well-being. • Additional recognition awards to celebrate your achievements.