MSAT Technical Lead – Drug Substance

Role Overview

• 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
• 10+ years of experience in the development and manufacturing of small-molecule drug substances for clinical and commercial use
• 5+ 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

• 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