MSAT Technical Lead — Sobi
NewCHF 85'500 - 129'500
Sobi · Basel (BS)
- Location
- Basel
- Contract
- full-time
- Posted
- 2 days ago
SalaryCHF 85'500 - 129'500
Role overview
Science and Technology (SAT) is part of the Global CMC, Science & Technology Department (GCSAT).
GCSAT is responsible for optimization and life cycle management of Sobi’s clinical and commercial manufacturing and analytical processes from internal and external network.
SAT ensures compliant, reliable, cost effective and sustainable manufacturing and testing of our products now and in future.
- Science and Technology (SAT) is part of the Global CMC, Science & Technology Department (GCSAT).
- GCSAT is responsible for optimization and life cycle management of Sobi’s clinical and commercial manufacturing and analytical processes from internal and external network.
- Key Responsibilities
- Subject matter expert (SME) for DP Aseptics manufacturing.
Main responsibilities
- Key Responsibilities
- Subject matter expert (SME) for DP Aseptics manufacturing.
- Process owner of DP Aseptics validation for Sobi products.
- Lead and execute MSAT projects such as manufacturing process and cost improvement as part of life-cycle management (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 SOP’s and manufacturing instructions.
- Review and supervise set up, 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 DP Aseptics contract manufacturers and participation in developing supply and quality agreements.
Application process
- How to apply We have an ongoing selection process in this recruitment and ask you to send your application as soon as possible.
- Click apply and include your resume in English.
- Why Join Us?
- Here at Sobi, our mission and culture get us excited to come to work every day, but here are a few more reasons to join our team: Emphasis on work/life balance
- Collaborative and team-oriented environment Opportunities for professional growth Diversity and Inclusion Competitive compensation for your work
- Making a positive impact to help ultra-rare disease patients who are in need of life saving treatments We are a global company with over 1,900 employees in more than 30 countries and are committed to the societies where we operate.
- With a deeply skilled management team directing our day-to-day wins, and a Board with a stellar track record, we’re ready to take on the world’s diseases, ailments and adversity.
- Our people believe they have the power to make a positive impact in others’ lives because that’s exactly what we do here.
Additional details
- Support SAT and Sobi’s continuous improvement program for internal business processes, systems and templates.
- Experience of regulatory guidelines, regulatory authorities’ communication and file documentation
- Here at Sobi, our mission and culture get us excited to come to work every day, but here are a few more reasons to join our team: Emphasis on work/life balance
- Collaborative and team-oriented environment Opportunities for professional growth Diversity and Inclusion Competitive compensation for your work
Notes and original content
- Key requirements
- Fluent in English
- Here at Sobi, our mission and culture get us excited to come to work every day, but here are a few more reasons to join our team:
- Emphasis on work/life balance
- Collaborative and team-oriented environment
- Opportunities for professional growth
- Diversity and Inclusion
- Competitive compensation for your work
