Senior Scientist, Functional Biocharacterization (all genders)

Senior Scientist, Functional Biocharacterization

Permanent contract

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

FR : Dans le cadre de sa politique Diversité, Evotec étudie, à compétences égales, toutes les candidatures dont celles des personnes en situation de handicap.

ENG : In the frame of our Diversity policy, Evotec considers, with equal competences, all applications including people with disabilities.

JOB ID-10247