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Scientist Ii Analytical Development Services
il y a 3 semaines
Scientist II Analytical Development Services
CDI/Permanent position
- General Summary_:
Just is seeking a motivated and creative Scientist, who desires a significant opportunity to improve worldwide access to biotherapeutics.
- Missions and responsibilities_:
- Development & Qualification of analytical methods (HPLC/CE related)
- Lead characterization of early and late-stage biotherapeutics (mAbs) using different analytical techniques
- Lead similarity and comparability assessments
- Lead technology transfer to Just’s Quality Control Laboratory
- Technical document authoring & author documents to support regulatory filings
- Contribute to team development by mentoring junior scientists
- Regular analysis and in-process support to the process development team
- Work with team members to support process development teams with high-throughput analytical procedures
- Involves in developing and implementing molecule characterization strategies
- Utilize chromatography data systems and informatics platforms to analyze and distribute analytical results
- Knowledge, skills and abilities_:
- Experience in biosimilar characterization specialized in mAbs
- Experience developing analytical methods in a CMC or GMP-like industry setting
- Hands-on experience on H/UPLC (SEC, RP, HILIC, IEX), CE (CE-SDS, icIEF)
- Desire to work in a fast, collaborative, team-oriented environment Strong analytical skills and experience in statistical analysis
- Strong oral and written English communication skills. French speaking would be an added value
- Experience and education_:
- PhD with 0-2 years relevant industry experience, MSc with 5+ years’ industry experience in Biochemistry, Molecular and Cell Biology, Bioengineering/Biotechnology or related field
- Other information_:
- Desire to work in a fast, collaborative, and team-oriented environment
- Mission générale
Just est à la recherche d'un(e) scientifique motivé(e) et créatif(ve), qui souhaite avoir une opportunité significative d'améliorer l'accès mondial aux biothérapeutiques.
Missions et responsabilités:
- Développement et qualification de méthodes analytiques (liées HPLC/CE)
- Caractérisation principale des produits biothérapeutiques (mAb) à un stade précoce et avancé à l'aide de différentes techniques analytiques
- Mener des évaluations de similarité et de comparabilité
- Diriger le transfert de technologie vers le laboratoire de contrôle qualité de Just
- Rédaction de documents techniques et de documents d'auteur pour prendre en charge les dépôts réglementaires
- Contribuer au développement de l'équipe en encadrant des scientifiques juniors
- Analyse régulière et soutien en cours de processus à l'équipe de développement de processus
- Travailler avec les membres de l'équipe pour soutenir les équipes de développement de processus avec des procédures analytiques à haut débit
- Participe à l'élaboration et à la mise en œuvre de stratégies de caractérisation de molécules
- Utiliser les systèmes de données chromatographiques et les plateformes informatiques pour analyser et distribuer les résultats analytiques.
Connaissances, compétences et aptitudes:
- Expérience en caractérisation biosimilaire spécialisée dans les mAbs
- Expérience dans le développement de méthodes analytiques dans un environnement industriel de type CMC ou GMP
- Expérience pratique sur H/UPLC (SEC, RP, HILIC, IEX), CE (CE-SDS, icIEF)
- Désir de travailler dans un environnement rapide, collaboratif et axé sur l'équipe. Solides compétences analytiques et expérience en analyse statistique.
- Solides compétences en communication orale et écrite en anglais. Parler français serait une valeur ajoutée
Expérience et formation:
- Doctorat avec 0 à 2 ans d'expérience pertinente dans l'industrie, Master II avec plus de 5 ans d'expérience dans l'industrie en biochimie, biologie moléculaire et cellulaire, bio-inginérie/biotechnologie ou dans un domaine similaire.
Autres informations:
- Désir de travailler dans un environnement rapide, collaboratif et axé sur l'équipe
