• 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.