Senior Scientist, Functional Biocharacterization

Senior Scientist, Functional Biocharacterization

Evotec

Toulouse, France

Just is seeking a motivated and creative Senior Scientist who desires a significant opportunity to improve worldwide access to biotherapeutics.

The new scientist will join a fast-paced, collaborative, and multidisciplinary team to develop and execute methods for the functional & potency assessment and impurity monitoring of biotherapeutics.  As a key member of the analytical group, the successful candidate will have significant experience in immunoassay, cell-based assay and qPCR method development and qualification/validation, as well as strong experimental design and data analysis skills.

Previous experience in biosimilar development, participation in CMC (Chemistry, Manufacturing, and Controls) teams and experience authoring regulatory documents is highly desirable. The ideal candidate has strong written and verbal communication skills, multitasks effectively, works well independently and in teams and is excited about ways to improve technology.

Responsibilities:

  • Expert in characterization of early and late stage biotherapeutics using diverse biological assay formats;
  • Lead immunoassay and kinetic assays, DOE robustness, analyze and present data;
  • Implement method development and qualification activities;
  • Biosimilarity and comparability assessments;
  • Technology development to improve throughput and efficiency & onboard new technologies;
  • Technology transfer to Just’s Quality Control laboratory;
  • Technical document authoring & author documents to support regulatory filings;
  • Participation in process development team(s);
  • Mentor and train junior staff.

Required Qualifications:

  • PhD with 3+ years relevant industry experience, MSc with 5+ years’ industry experience, or BS with 10+ years’ experience, with degrees in Biochemistry, Molecular and Cell Biology, Bioengineering Chemistry or related field;
  • Experience in biosimilars characterization;
  • Experience developing analytical methods in a CMC or GMP-like industry setting;
  • Experience developing and applying biological characterization methods (e.g. cell-based assays, including primary cell assays, SPR & other protein binding kinetic assays, immunoassays) and in technology development pertinent to impurities and potency assay;
  • Expertise qualification and/or validation of release potency and impurity methods (cell-based assays, immunoassays and qPCR);
  • Strong technical understanding of link between MOA and analytical method development, and effects of impurities on biological manufacturing processes;
  • Strong analytical skills and experience in statistical analysis;
  • Strong oral and written English communication skills;
  • Desire to work in a fast, collaborative, and team-oriented environment.

Preferred Qualifications:

  • General understanding of ICH/USP guidelines on analytical, impurity, and potency assay development and validation for biological products;
  • Previous experience in biosimilar development;
  • Experience with early & late stage regulatory filings;
  • Experience in technology transfer;
  • Experience participating in CMC teams;
  • Good written and verbal French communication skills will be a plus.

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