Manufacturing Science and Technology Drug Product Lead
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Job Description
Manufacturing, Science and Technology Drug Product Lead at Sobi developing innovative therapies for rare diseases. Overseeing drug product manufacturing with a focus on technical excellence.
Responsibilities:
- 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.
Requirements:
- University education in Chemistry, Pharmacy or similar.
- +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
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