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Le poste

Senior Bioanalytical Project Manager - Scientist III, PK/TK LBA, immunogenicity/ADA and Biomarkers

 

As a Scientist III at KCAS Bio, you will qualify, validate and execute test methods for the evaluation of soluble and cellular biomarkers, for pharmacokinetics PK /toxicokinetics TK and immunogenicity in a service provider company specialized in non-regulated and regulated bioanalysis. In this role, we will rely on you to: • Lead multiple projects in LBA complying to applicable ICH M10/FDA/EMA guidelines under both Good Laboratory Practice (GLP) and Good Clinical Laboratory Practice (GCLP) environments. • You set up and supervise PK/ ADA, biomarkers qualification/validation and testing studies within the laboratory. • You define the design of these studies according to the applicable standards and coordinate a technical team for the good execution of experiments for client sponsored projects • You ensure customer contact in connection with the studies you manage, you provide an advisory role. • Write project documentation (analytical test methods, development reports and protocols) of high complexity • Participate in the scientific promotion of results • Be proactive in implementing new techniques and technologies in the lab to offer innovative services to our clients • Supervise/provide technical training of students or collaborators and mentoring to more junior scientists (Scientists I and II).

 

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L'entreprise

KCAS BIO (formely Active Biomarkers)

 

KCAS BIO Lyon is an integrated bioanalytical laboratory offering a wide range of in-vitro immunology services, including soluble and cellular biomarker analyses for preclinical and clinical studies. Operating in BSL2 facilities, and GLP/GCLP/ISO 9001:2015 environment, the company currently employs roughly 40 scientists bringing a wealth of experience in the development, validation, and implementation of analytical methods. Its know-how is recognized in 4 major therapeutic areas: oncology, infectious diseases, inflammatory pathologies, and neurodegenerative diseases. Beyond its state-of-the-art flow cytometry and ELISpot capabilities, Active Biomarkers offers the broadest panel of immunoassay technologies in Europe, ranging from standard ELISA to multiplexed methods such as Luminex or ELLA systems, and ultra-sensitive technologies such as MSD, Simoa HD-X and Fujirebio Lumipulse G1200.

 

Domaine d'application

  • Biotech - Pharma

Fonction

  • R&D & Etudes

Contrat

  • CDI

Expérience

  • De 5 à 10 ans

Niveau d'étude

  • BAC + 5 / Master
  • Supérieur à BAC + 5

Localisation

  • 69 - Rhône

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