Senior Scientist I, Functional Biocharacterization & Impurities
Location: Redmond, WA
The Role:
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.
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
Required Qualifications:
- 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
Preferred Qualifications:
- Experience utilizing industry-standard analysis software (e.g. SoftMax Pro, JMP, Microsoft Office)
- Experience with late stage regulatory filings
The base pay range for this position at commencement of employment is expected to be $$126,000 to $137,000; Base salary offered may vary depending on individual’s skills, experience and competitive market value. Additional total rewards include discretionary annual bonus, comprehensive benefits to include Medical, Dental and Vision, short-term and long-term disability, company paid basic life insurance, 401k company match, flexible work, generous paid time off and paid holiday, wellness and transportation benefits.
