Senior Scientist I, Functional Biocharacterization & Impurities

Evotec•Redmond, WA

1d•$126,000 - $137,000•Onsite

About The Position

Just - Evotec Biologics is seeking a motivated and creative senior scientist who desires a significant opportunity to improve worldwide access to biotherapeutics. The candidate will join a fast-paced, collaborative, and multidisciplinary team to develop and execute methods for assessment of the function and potency of biotherapeutics. As a key member of the analytical development group, the successful candidate will have significant experience in cell-based assays in an array of formats and experience with method development and phase-appropriate validation. Previous experience in late phase biologics development and/or biosimilar development, participation in CMC teams, and experience authoring regulatory documents is highly desirable. Previous experience directly managing a diverse group of analytical scientists (potency/bioassay) 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. The candidate will also be involved in leading cross-functional initiatives and supervising direct reports.

Requirements

PhD with 3+ years relevant industry experience, MS with 5+ years’ industry experience, or BS with 10+ years’ experience, with degrees in Biochemistry, Molecular and Cellular Biology, Chemical Engineering, Bioengineering, Chemistry or related field
Understanding of ICH/USP guidelines on analytical and potency assay development and validation
Experience in the development and phase-appropriate validation of potency and methods
Experience managing and mentoring direct reports
Strong technical understanding of link between Mechanism of Action and analytical method development. Understand the effects of impurities on biological manufacturing processes
Experience in areas of technology development pertinent to potency assay development, including but not limited to, FcgR effector function assay development, large-scale cell banking, and image and flow cytometry
Strong oral and written communication skills
Desire to work in a fast, collaborative, and team-oriented environment

Nice To Haves

Previous experience in late phase biologics development and/or biosimilar development, participation in CMC teams, and experience authoring regulatory documents is highly desirable.
Previous experience directly managing a diverse group of analytical scientists (potency/bioassay) is highly desirable.
Experience utilizing industry-standard analysis software (e.g. SoftMax Pro, JMP, Microsoft Office)
Experience with late stage regulatory filings

Responsibilities

Serve as a subject matter expert in development of a wide range of formats of cell based assays for early and late phase biologics programs
Lead a team of scientists to implement method development and phase-appropriate validation activities for cell based assays in a wide range of formats
Supervise and develop the careers for direct reports; mentor and train junior staff
Transfer methods to Just - Evotec's Quality Control laboratory
Technical document authoring
Participate in process development teams, potentially serving as potency lead and as analytical team lead
Execute comparability and biosimilarity assessments
Technology development to improve throughput, efficiency, and onboard new technologies
Author and contribute to documents to support regulatory filings (including IND, INDa, BLA, IMPD)
Present data to a wide range of audiences, including internal technical development teams, clients, industry conferences, and peer-reviewed journals
Lead cross-functional teams and initiatives