MSAT Technical Lead – Drug Substance

Responsibilities

• 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 SOPs 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.

Tools & Technologies

• SOPs
• Manufacturing instructions
• Supply agreements
• Quality agreements

Hard Skills

• Process validation
• Manufacturing process improvement
• Technical studies documentation
• Product transfer
• Scale‑up activities
• Validations
• APR documentation
• PQR documentation
• CMC development
• Regulatory guidelines

Soft Skills

• Leadership
• Multitasking
• Prioritization
• Decision‑making
• Cross‑functional teamwork