Senior Scientist I, Functional Biocharacterization & Impurities
Evotec
August 18, 2026
On-site
Redmond, WA
Clinical Research and Development
Responsibilities:
- Serve as a subject matter expert in development of cell-based assay formats for early and late phase biologics programs.
- Lead a team to implement method development and phase-appropriate validation for cell-based assays across formats.
- Supervise and develop direct reports; mentor and train junior staff.
- Transfer methods to Quality Control laboratory.
- Author technical documents.
- Participate in process development teams (potentially as potency lead and analytical team lead).
- Execute comparability and biosimilarity assessments.
- Lead technology development to improve throughput, efficiency, and onboard new technologies.
- Author and contribute to regulatory filing documents (IND, INDa, BLA, IMPD).
- Present data to internal teams, clients, conferences, and peer-reviewed journals.
- Lead cross-functional teams and initiatives.
Required Qualifications:
- PhD (3+ years), MS (5+ years), or BS (10+ years) in Biochemistry, Molecular/Cellular Biology, Chemical Engineering, Bioengineering, Chemistry, or related.
- Understanding of ICH/USP guidelines for analytical and potency assay development/validation.
- Experience in development and phase-appropriate validation of potency and methods.
- Experience managing and mentoring direct reports.
- Strong understanding of link between Mechanism of Action and analytical method development; effects of impurities on biological manufacturing.
- Technology development experience relevant to potency assays (e.g., FcgR effector function assays, large-scale cell banking, image/flow cytometry).
- Strong oral and written communication; ability to thrive in fast-paced, collaborative environments.
Preferred Qualifications:
- Experience with SoftMax Pro, JMP, and Microsoft Office.
- Experience with late-stage regulatory filings.
Application Instructions:
- Take the leap and apply today.
- Serve as a subject matter expert in development of cell-based assay formats for early and late phase biologics programs.
- Lead a team to implement method development and phase-appropriate validation for cell-based assays across formats.
- Supervise and develop direct reports; mentor and train junior staff.
- Transfer methods to Quality Control laboratory.
- Author technical documents.
- Participate in process development teams (potentially as potency lead and analytical team lead).
- Execute comparability and biosimilarity assessments.
- Lead technology development to improve throughput, efficiency, and onboard new technologies.
- Author and contribute to regulatory filing documents (IND, INDa, BLA, IMPD).
- Present data to internal teams, clients, conferences, and peer-reviewed journals.
- Lead cross-functional teams and initiatives.
Required Qualifications:
- PhD (3+ years), MS (5+ years), or BS (10+ years) in Biochemistry, Molecular/Cellular Biology, Chemical Engineering, Bioengineering, Chemistry, or related.
- Understanding of ICH/USP guidelines for analytical and potency assay development/validation.
- Experience in development and phase-appropriate validation of potency and methods.
- Experience managing and mentoring direct reports.
- Strong understanding of link between Mechanism of Action and analytical method development; effects of impurities on biological manufacturing.
- Technology development experience relevant to potency assays (e.g., FcgR effector function assays, large-scale cell banking, image/flow cytometry).
- Strong oral and written communication; ability to thrive in fast-paced, collaborative environments.
Preferred Qualifications:
- Experience with SoftMax Pro, JMP, and Microsoft Office.
- Experience with late-stage regulatory filings.
Application Instructions:
- Take the leap and apply today.