Senior Scientist II, Functional Biocharacterization & Impurities

Evote; Union Hill-Novelty Hill (WA); On-site; USD 126,000 - 140,000; Full time

Benefits offered by this job

Medical, Dental, Vision

401k company match

Flexible work

Paid time off

Wellness program

Transportation benefits

Job summary

Evotec (US) Inc. in Redmond, WA, is seeking a Senior Scientist II to lead the development and validation of cell-based assays for early and late phase biologics programs.

The role includes supervising a team, mentoring staff, transferring methods to QC, and authoring regulatory documents. The ideal candidate has a PhD (or MS/BS with substantial industry experience) and strong communication skills, with a track record in potency assay development and cross-functional collaboration.

Qualifications

• PhD/MS/BS with stated industry experience per fields
• ICH/USP guidelines familiarity for analytical/potency assay development
• Experience with potency/method validation in pharma
• Experience managing direct reports
• Ability to link mechanism of action to analytical method development

Responsibilities

• Develop and validate cell-based assays for biologics programs
• Lead and mentor a team of scientists and develop careers
• Transfer methods to QC labs and author regulatory documents
• Participate in cross-functional teams and regulatory filings (IND, BLA, IMPD)
• Present data to internal and external audiences
• Drive technology development to improve throughput and capabilities

Skills

Cell-based assays

Team leadership

Regulatory knowledge

Mentoring

Education

PhD in Biochemistry / Molecular & Cellular Biology / Chemical Engineering or related

MS with 5+ years of experience

BS with 10+ years of experience

Tools

SoftMax Pro

JMP

Microsoft Office

Job description

Job Title: Senior Scientist II, Functional Biocharacterization & Impurities

Location: Redmond, WA

About Us:

At Just-Evotec, we believe that curiosity is the spark that drives innovation and success. As a forward-thinking team, we thrive on challenging the status quo, learning from each other, and pushing the boundaries of what’s possible. We're on a mission to create a place where curiosity isn't just encouraged, it’s celebrated.

Are you someone who asks questions, seeks answers, and isn't afraid to go deeper?#BeCureious with us and see where your curiosity can take you!

The Role:

Just-Evotec 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

Why Join Us:

• Growth Opportunities: We’re a company that believes in continuous learning and development. Whether it’s professional courses, mentorship, or new projects, we’ll help you grow.
• Inclusive Culture: We’re committed to building a diverse and inclusive environment where everyone’s voice is valued, and curiosity is encouraged.
• Innovative Projects: You’ll have the chance to work on groundbreaking initiatives and cutting-edge technology in an atmosphere where your curiosity is the key to success.
• A Place for Big Ideas: We don’t just talk about thinking outside the box—we throw the box away. If you’ve got ideas, we want to hear them.

The base pay range for this position at commencement of employment is expected to be $126,000-$140,000;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.

Evotec (US) Inc. is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, gender, age, disability, genetic information, gender expression, gender identity, national origin, religion, sexual orientation, or veteran status.