Senior Toxicologist

작업 내용

Senior Toxicology Consultant (m/f/d)
Your role as a senior consultant for toxicology in the medical device industry.
▪ Supporting our clients in the field of biocompatibility, toxicology, microbiology, cleaning and sterilization of medical devices and processes in the fields of Quality Assurance, Production, R&D, Supplier Quality Management and Regulatory Affairs (ISO 13485, ISO 14971, ISO 11135, ISO 11137, ISO 19227).
▪ Develop strategies for toxicology/biocompatibility risk assessment and review/write the toxicological/ biocompatibility risk assessments.
▪ Assessment of client`s medical device test data to identify and remediate any deficiencies with regard to biocompatibility, toxicology, and microbiology of medical devices.
▪ Assesses the biological safety impact from manufacturing and supplier changes on patient-contacting devices.
▪ Ensuring appropriate documentation in accordance with national & international regulations demanded.
▪ Supporting our clients and their suppliers during audits and inspections.
▪ Cultivating and active care of client relations.

Your profile:
▪ Master or Ph.D. in natural or life sciences (e.g., toxicology, biology, biochemistry, chemistry, pharmacology, medicine, or similar) and certification as ERT (European Registered Toxicologist) or DABT (Diplomate of the American Board of Toxicology) are a must.
▪ You have min. >5 years of work experience in the industry (e.g., medical devices, pharmaceuticals, tobacco) or at a contract research organization (CRO) writing toxicological risk assessments and biological safety assessments.
▪ You have expert knowledge in the field of preclinical studies (in-vitro and in-vivo), biocompatibility assessments, and the toxicological risk assessment of substances, mixtures, raw materials, active ingredients, and auxiliary materials.
▪ You have an understanding of drug metabolism, toxicokinetics, and molecular and cellular toxicology.
▪ Knowledgeofapplicableregulatoryrequirements(e.g.,ICH,ASTM,ISO,FDA,GLP,MDR) and in-depth
understanding of ISO 10993 and ISO 18562 series. Know-how in the field of predictive QSAR models for physical/chemical properties and human health toxicological endpoints, such as EPI Suite or the OECD QSAR Toolbox is an advantage.
▪ You solve complex tasks using your analytical abilities in a client-orientated fashion supported by your confident manner and excellent communication.
▪ You are able to handle multiple tasks/projects and manage priorities accordingly.
▪ It is a prerequisite for us that you are prepared to work and travel worldwide.
▪ English(≥C2)andGerman(≥B1)is a must.Additional languages are an advantage.

What is your motivation?
▪ Briefly describe to us how the lifestyle of a consultant is compatible with your private situation.
▪ How do you organize your working day to be able to work on the move and at your home office?
▪ From when are you available and what is your salary requirement?

Become part of our team and apply now!

Send us your complete application documentation (motivation letter, CV and
references) as PDF with reference to STA202200301B to recruiting@jlsc.ch.