Bioanalytical Study Manager H/F Excelya
- Boulogne-Billancourt - 92
- CDI
- Bac +5
- Industrie Pharmaceutique • Biotechn. • Chimie
Les missions du poste
AbouttheJob
JoinExcelya,whereAudacity,Care, andEnergydefinewhoweareandhowwework.Webelieveincreatingboldsolutionsandfosteringaninclusiveenvironmentwherecollaborationandindividualgrowthgohandinhand.
Thisroleisanexcitingopportunitytocontributetoadynamic,ambitiousteam.Youwillplayacriticalpartindrivinginnovationandmakinganimpactintheclinicalresearchspace, whileenjoyingastimulatingprofessionalenvironmentthatencouragespersonalandintellectualgrowth.
- Monitor outsourced regulated bioanalytical studies to ensure scientific integrity and compliance with GLP/GCP/ICH standards.
- Review and approve bioanalytical study documents (protocols, validation reports, sample analysis plans, final reports).
- Provide scientific oversight on LC-MS/MS methods for small molecule quantification.
- Evaluate and validate bioanalytical data for accuracy, precision, and robustness.
- Troubleshoot analytical issues and support CROs with technical guidance.
- Perform or supervise non-compartmental pharmacokinetic (NCA) analyses and interpret PK data.
- Ensure CRO performance and compliance through monitoring and documentation reviews.
- Act as primary liaison between internal stakeholders (Clinical, Non-clinical, Regulatory, QA) and external partners (CROs).
- Present bioanalytical and PK results in internal meetings and regulatory submissions.
- Maintain high-quality documentation aligned with internal SOPs and regulatory requirements.
Le profil recherché
WhyJoinUs?
AtExcelya, wecombinepassionforsciencewithenthusiasmforteamworktoredefineexcellenceinhealthcare.
Here'swhatmakesusunique-
Weareayoung, ambitioushealthcompanyrepresenting900Excelyates,driventobecomeEurope'sleadingmid-sizeCROwiththebestemployeeexperience.Ourone-stopproviderservicemodel-offeringfull-service,functionalserviceprovider,andconsulting-enablesyoutoevolvethroughdiverseprojects.Workingalongsidepreeminentexperts,youwillhelpimprovescientific,operational, andhumanknowledgetoenhancethepatient'sjourney.
Excellingwithcaremeansbenefitingfromanenvironmentthatvaluesyournaturaltalents,pushesboundarieswithaudacity,andnurturesyourpotential, allowingyoutocontributefullytooursharedmission.
About You
At Excelya, taking audacious steps is encouraged, so we're looking for individuals who are ready to grow with us and share our values.
- Experience : At least 5 years of experience in regulated bioanalytical studies within the pharmaceutical or CRO industry, with a proven track record in LC-MS/MS methods and non-compartmental pharmacokinetic (NCA) analysis.
- Skills : Strong expertise in method development, validation, and sample analysis for small molecules., Solid knowledge of GLP, GCP, ICH M10, and regulatory standards related to bioanalysis, Demonstrated ability to monitor and oversee external CROs, ensuring compliance and scientific quality, Experience with Watson LIMS, ligand-binding assays, or oligonucleotide bioanalysis is a plus.
- Education : Advanced degree (PhD, PharmD, MSc) in Pharmaceutical Sciences, Analytical Chemistry, Biochemistry, or a related discipline.
- Languages : Fluency in French & English is required; knowledge of additional languages (e.g., Chinese) is an asset.
Bienvenue chez Excelya
Excelya is an independent partner that serves Biotech, Pharma, and Medical Device organizations with a comprehensive range of full-service CRO, FSP, and Resourcing solutions guided by our values Energy, Care and Audacity.
Founded in 2014 and headquartered in Paris, France, Excelya has a global team of 900+ experts who understand the critical needs of clients to provide bespoke and robust trial solutions across a broad spectrum of therapeutic areas.
We take a one-team approach to work : our shared success is the result of collaboration at every stage of a project, from regulatory affairs and clinical operations to quality assurance and strategic development.
Excelya is committed to helping our clients deliver life-changing therapies collaboratively, so we can transform tomorrow together.
Localiser le poste
Publiée le 25/08/2025 - Réf : 73ef0893-33f5-4596-b24f-0f2ddc9924b4
Bioanalytical Study Manager H/F
- Boulogne-Billancourt - 92
- CDI
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