Senior Scientist & Quality Lead

In this position, you will be a key driver in our laboratory research while taking a leading role in designing and building a tailored Quality Management System (QMS) ensuring reliability and excellency to our diagnostic innovations.

Your research topics will mainly cover our phage-biosensor development based on bacteriophage constructs. The work will include developing biosensors towards different disease biomarkers related to cancers and to infectious diseases, to perform sample preparation and analyzing bioassays. The work also includes development of in-vitro evolution processes of phages, and to perform complementary tests using traditional methods. Your duties also consist of documentation, drafting scientific publications, and close collaboration with our clinical partners.

Key Responsibilities:
Senior Scientist (50%):
– Key member of our research team and contributor of our phage-biosensor method.
– Developing and optimizing bioassays for infectious diseases and cancer biomarkers.
– Managing in-vitro evolution of phages and collaborating with international clinical and academic partners.
– Interpreting measurement data and drafting scientific publications.
Development & Quality Leadership (QMS, 50%):
– Driving the development: You will play a foundational role in designing and implementing a QMS that is fit-for-purpose for a high-growth diagnostics startup.
– Process Architecture: Establishing and documenting core processes, from sample handling to data integrity, ensuring they meet industry best practices (e.g., ISO 9001 or GLP/GCLP standards).
– Quality Documentation: Drafting and managing the companys quality manual, SOPs, and validation protocols to ensure a scalable and robust operational framework.
– Continuous Improvement: Leading internal audits and fostering a proactive ”Quality First” mindset throughout the scientific team.

What We Expect From You
– Education: Ph.D. or M.Sc. in Biochemistry, Biotechnology, or a related discipline.
– Research Track Record: Extensive experience in bioassay development and the measurement of clinical samples.
– Quality Management Vision: A background in QMS (e.g., ISO 9001, GLP) and a passion for building quality systems from the ground up rather than just following existing ones.
– Independent & Proactive: Ability to independently design both laboratory experiments and quality workflows.
– Communication: Fluency in English and excellent technical writing skills are essential for both scientific and quality documentation.

Osaamisalue: Farmasia & lääketeollisuus, Hallinto- & toimistotehtävät, Tutkimus, kehitys & tuotekehitys