GMP Scientist

Wyss Zurich
GMP Scientist
60-100 %
The Wyss Zurich Translational Center is a joint accelerator of the ETH Zurich and the University of Zurich, which was made possible by a generous donation from the Swiss entrepreneur and philanthropist Dr. hc. mult. Hansjörg Wyss. The mission of Wyss Zurich is to drive the clinical translation and technology transfer of outstanding scientific discoveries into new therapies for patients and breakthrough innovations in the emerging fields of Regenerative Medicine and Robotics, and to promote hybrid technologies in these fields. Wyss Zurich brings together some of the world's leading experts to form multidisciplinary teams, pooling their knowledge and expertise.
LifeMatrix is part of the Wyss Zurich Translational Center since 2015. LifeMatrix is active in the fast-growing field of medical biomimetics and has developed a unique tissue engineering technology to grow human replacement tissues in the laboratory as next-generation implants for the treatment of cardiovascular diseases. When implanted, the patient's own cells will vitalize and transform the LifeMatrix tissue into living heart valves and blood vessels, which can grow and regenerate with the patient. The LifeMatrix technology has the potential to overcome the significant limitations of existing implants and revolutionize the medical device industry.
Your responsibilities
Your responsibilities will include the support of documentation of our next generation-biomimetic implants for clinical use. You have an active role in supporting GMP manufacturing by creating relevant GMP and ISO 13485 documentation and driving optimization and harmonization of the processes. You will be supporting with documentation the clean room facilities (GMP class B / ISO 5) of the Wyss Zurich located at Moussonstrasse.
Your main tasks include:
Conceptual work:

• Author protocols of the manufacturing work instruction in adherence to all relevant SOP's.
• Standardization and improvement of manufacturing processes.
• Interpret results, evaluate data, draw relevant conclusions.
• Perform process risk analysis.
• Communicate effectively, suggest alternative strategy in problem solving.
• Initiate, write and investigate production deviations and act as a catalyst for root cause investigation and continuous improvement.
• Write/review method verifications
• Write/review equipment qualifications, create operating instructions.
• Act as an expert/intermediate in analytics related topics.
• Author, review and edit internal protocols and other documents to support GMP activities.
• Lead own function and fulfil all project tasks and responsibilities related to the own discipline, consolidate resource needs and timelines for projects.
• Design, plan and monitor own activities.
• Communicate, address, and solve problems within the own and broader area of responsibilities.

Your profile
The ideal candidate has an apprenticeship or university degree in Chemistry, Biology, or another relevant discipline. Strong knowledge and interest in manufacturing operations is required. Experience within a biotech/pharmaceutical manufacturing environment (GMP or ISO 13485) is a plus, but not necessary. Previous work experience with cell cultures, tissue engineering, extracellular matrix and/or biodegradable polymers is a big plus. Basic knowledge of statistics is highly desired.
Desired skills:

• Very well organized and self-disciplined
• Has good multitasking skills and can combine practical and conceptual work
• Can simplify/explain complex concepts and break them into achievable goals/tasks
• Has a flexible, open (solution oriented) and positive mindset
• Reliable and stress resistant
• Has an analytical and structured working style
• Gives strong attention to details
• Is able to effectively work in a multicultural and multidisciplinary team
• Has good verbal and written communication skills in English

What we offer
We offer the unique opportunity to be part of a multidisciplinary startup team of young scientists, world-leading experts in tissue engineering and entrepreneurs who share the vision to help children with a congenital heart defect to have a better life.
As part of the Wyss Zurich family, you further benefit from the international university environment of the University of Zurich and the ETH Zurich. You are part of a selected community of translational researchers, entrepreneurs, and industry experts.
Place of work
Moussonstrasse, Zürich, Switzerland
Start of employment
01.04.2022 (or upon agreement)
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