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

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

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

MSAT Technical Lead – Drug Substance

Key skills