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
• Other job related tasks

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
• Making a positive impact to help ultra-rare disease patients who are in need of life saving treatments