Manufacturing, Science and Technology Lead

Role Overview

• 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.

Requirements

• University education in Chemistry, Pharmacy or similar.
• +5-10 years of experience of development and manufacturing of oral dosage forms, drug products, with small molecules for clinical and commercial use.
• Recognized expert in Drug product manufacturing of hard-gelatine capsules.
• Scientific and technical background of CMC development and GMP-compliant manufacturing in for small molecule drug products.
• Demonstrable experience of working in cross functional team with ability to lead functional teams, prioritize and be an effective decision maker.
• Experience of working with External manufacturers.
• Experience of regulatory guidelines (FDA & EMA), regulatory authorities communication and filing documentation.
• Fluent in English, intermediate to full proficiency in Chinese is a plus.

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