Join one of the most promising company in the Swiss Medtech environment.
Abionic is committed to revolutionize the world of in vitro diagnostics with rapid universal point-of-care solutions. Based on disruptive technology, Abionic is offering the world of healthcare a novel point-of-care diagnostic tool and thereby fill patient’s unmet needs.
Abionic is an innovative company located in the Lausanne area, Switzerland. It is ideally positioned at the boundaries of medical technology, biotechnology and nanotechnology.
Abionic is a fast-growing company with ambitious objectives, spin-off of EPFL and a proud member of Health Valley Switzerland.
We are looking a Head of Assay Design Transfer to complete our team.
To complete our team, we are looking for a Senior Scientist who is motivated to bring his/her expertise and experience in the development of our point-of-care IVD assays. In this position you will report directly to our Chief Science Officer.
Your tasks will be to:
To complete our team, we are looking for a Senior Scientist who is motivated to bring his/her expertise and experience in the development of our point-of-care IVD assays. In this position you will report directly to our Chief Science Officer. Your tasks will be to:
- Lead a team responsible for verification, validation and design transfer of IVD products. This team has the responsibility to:
- Ensure product performance by applying ISO 13485 development practices, focusing on optimizing reagents, methods and/or processes to ensure product manufacturability.
- Verify and validate the product’s analytical performances and manufacturing processes against the requirements.
- Writing of corresponding documentation in accordance with the Company’s QMS and applicable regulatory requirements (in particular EU IVDR 2017/746 and US FDA 510(k)).
- Deliver efficient, sustainable processes to Abionic Manufacturing Operations and participate in efforts and share ideas to define new components, products or processes associated with manufacturing.
- Work independently with high level direction provided by Senior Management, while developing strong collaborative working relationships between Early Product Development, Industrialization and Quality Control.
- Actively solicit technical input and conversely provide input into other projects to generate discussion and a sense of shared success.
- Degree in Life Sciences, or equivalent, with a strong background in biochemistry and relevant professional experience in the medical device in vitro diagnostic industry.
- Prior experience in IVD product development in regulated environment.
- Proven ability to lead multiple project teams and managing multiple projects simultaneously.
- A leadership that creates strong, highly engaged, and productive project teams, fostering a culture of efficient communication and collaborations with other teams (regulatory affairs, quality assurance, quality control, industrialization, manufacturing, etc).
- Excellent organizational and planning skills; able and willing to work with a high level of autonomy and independence within a dynamic and agile team.
- Outstanding rigor, attention to details, dedication and sense of responsibility; able to maintain high level of effectiveness in demanding environment.
- Excellent command of English, with knowledge of French being a plus.
Abionic is a fast-growing, multi-award winning IVD company, located in one of the most dynamic clusters for life science and medical device companies, as part of our young, talented, and ambitious team.
A challenging job within an exciting medtech company,
Integration in a dynamic growing team,
A highly innovative environment,
An opportunity to improve healthcare.
Starting date: a soon as possible
Activity rate: 80 – 100%
Would you like to work in a challenging environment and to integrate a dynamic team?
Please send your application (CV and motivation letter) to email@example.com with reference to the position of ‘Head of Assay Design Transfer’.