Careers
join our team
Are you looking for a positive and stimulating work environment? Joining Amolyt Pharma means choosing a fast growing, international and pioneering company committed to providing innovative treatments to patients suffering from rare endocrine and metabolic diseases. We are always looking for passionate and talented individuals to join our dedicated team to help us achieve our mission.
Please note that all our job vacancies are published on this page. For safety purposes, please do not respond to solicitations for positions not listed on this page.
Explore our open position(s) below:
Ideally based in Lyon, France, but remote possible, permanent contract
Building on our know-how and experience in the field of therapeutic peptides, our mission is to develop innovative treatments to improve the lives of patients suffering from rare endocrine diseases.
After just a few years, the company has a portfolio of 3 products, one of which is entering phase 3 and the 2nd has just entered phase 1. Building on our encouraging results and a €130 million Series C financing led by Sofinnova Partners and co-managed by Intermediate Capital Group, we are continuing our development and creating the position of Bioanalytical Manager.
I – THE POSITION:
Reporting to the Director of Non-Clinical Development, you will put your scientific and technical experience at the service of the teams in order to implement bioanalytical strategies to ensure the success of preclinical and clinical development programs.
Tasks:
- Define the bioanalytical/biomarker strategy for measuring the desired biological parameters (pharmacokinetics, pharmacodynamics, immunoneutralization, biomarkers, etc.) in collaboration with the preclinical and clinical development teams.
- Implement bioanalysis and biomarker measurement strategies to assess the safety and efficacy of the compounds developed.
- Identify, qualify and manage external service providers for the development and validation of bioanalytical methods in compliance with GLP/GCP requirements.
- Oversee the transfer/development and validation of methods, as well as the analysis of samples by selected CROs.
- Ensure that bioanalytical development and validation reports comply with regulatory requirements, good scientific practices and quality standards.
- Interpret bioanalysis results and identify and resolve any problems.
- Participate in drafting the bioanalytical sections of preclinical and clinical reports.
- Prepare and/or revise the bioanalytical sections of the various regulatory documents (briefing package for CTA, IND, LBA, NDA).
- Monitor technological and regulatory developments in the field of bioanalysis.
II – PROFILE:
With a PhD or equivalent in bioanalysis/analytical sciences, you have 5 to 10 years' proven operational experience in pharmaceutical development in pharmaceutical, biotech companies or CROs, where you also have developed expertise in preclinical and clinical pharmacokinetics.
As an expert in development, qualification and transfer of methods (LC-MS/MS, hybrid LC-MS/MS, cell-based and ligand binding assays (ELISA, ECLIA), bioassays, etc.), you have excellent organizational, planning and project management skills.
You know how to select and manage subcontractors (CROs) and steer them to ensure that studies are properly conducted within the allocated budgets and timelines.
Rigorous and highly autonomous, you have excellent communication skills, both written and oral, and your English is fluent.
Please send your CV in readable format (Pdf, not scanned, to ensure your application is processed correctly), ref. 23-351-05, to our consultant: Hélène CLERC ALERYS annonce@alerys.fr