Principal Scientist Analytical Development and Support
Principal Scientist, Analytical Development and SupportJust-Evotec Biologics is seeking a motivated and creative Senior Scientist II/Principal Scientist who desires a significant opportunity to improve worldwide access to biotherapeutics.
The new hire will join a fast-paced, collaborative, and multidisciplinary team to build and lead a group to develop and execute separations methods for support of process development, cell line development, and release testing of biotherapeutics.
As a Senior Scientist II/Principal Scientist in the Analytical Development and Support group, you will possess strong skills in H/UPLC and CE method development, method qualification, and large molecule characterization.
Experience as a late stage analytical strategy lead with an understanding of comparability and/or similarity studies, participation in CMC teams, and authoring regulatory authority correspondence and interaction is preferred.
The successful candidate will possess strong leadership and management skills.
Experience with biosimilar development, liquid handling robotics, and leading CMC teams is strongly desired.
The ideal candidate has strong written and verbal communications skills and works well independently and in teams.
Responsibilities:
Analytical team lead/CMC leadBuild and lead a diverse group encompassing all aspects of separations methods development and high throughput support, qualification/validation of methods, and tech transfer to Quality ControlCollaborate across the organization to speed time to clinic while reducing development costsManage staffServe as a technical resource on cross functional teams for separations methodsLead a team to develop, qualify, and document analytical methodsWork with team members to support process development teams with high-throughput analytical proceduresUtilize chromatography data systems and informatics platforms to analyze and distribute analytical resultsWork with team members on technology development to reduce the cost and improve the efficiency, speed, and capacity of analytical testing and analytical methodsSupervise and mentor Scientists and AssociatesRequirements:
BS/MS in Biochemistry, Biology, Bioengineering or related field with 15
years of experience or Ph.
D.
with 7
years of experience.
Expertise in the development and qualification and/or validation of H/UPLC (SEC, RP, HILIC, IEX), CE (CE-SDS, icIEF) methodsLarge molecule and protein characterization experienceExperience with biosimilar development and biosimilarity studiesExperience in CMC development teams as an Analytical LeadStrong mentoring, managerial, and leadership skillsStrong oral and written communication skillsExperience with early & late stage regulatory filingsExperience in Team management (3-5 people) & LeadershipPreferred
Qualifications:
Use of liquid-handling automation applicationsExperience with troubleshooting complex instrumentationDirect interactions with FDA and other regulatory agenciesKnowledge of mass spectrometry methodsCharacterization of complex GlycoproteinsExperience with compendial assays (USP, EP, JP)Strength in data science and informaticsThe base pay range for this position at commencement of employment is expected to be $135,000 to $180,000; 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.
SummaryLocation:
RedmondType:
Full time.
Estimated Salary: $20 to $28 per hour based on qualifications.
The new hire will join a fast-paced, collaborative, and multidisciplinary team to build and lead a group to develop and execute separations methods for support of process development, cell line development, and release testing of biotherapeutics.
As a Senior Scientist II/Principal Scientist in the Analytical Development and Support group, you will possess strong skills in H/UPLC and CE method development, method qualification, and large molecule characterization.
Experience as a late stage analytical strategy lead with an understanding of comparability and/or similarity studies, participation in CMC teams, and authoring regulatory authority correspondence and interaction is preferred.
The successful candidate will possess strong leadership and management skills.
Experience with biosimilar development, liquid handling robotics, and leading CMC teams is strongly desired.
The ideal candidate has strong written and verbal communications skills and works well independently and in teams.
Responsibilities:
Analytical team lead/CMC leadBuild and lead a diverse group encompassing all aspects of separations methods development and high throughput support, qualification/validation of methods, and tech transfer to Quality ControlCollaborate across the organization to speed time to clinic while reducing development costsManage staffServe as a technical resource on cross functional teams for separations methodsLead a team to develop, qualify, and document analytical methodsWork with team members to support process development teams with high-throughput analytical proceduresUtilize chromatography data systems and informatics platforms to analyze and distribute analytical resultsWork with team members on technology development to reduce the cost and improve the efficiency, speed, and capacity of analytical testing and analytical methodsSupervise and mentor Scientists and AssociatesRequirements:
BS/MS in Biochemistry, Biology, Bioengineering or related field with 15
years of experience or Ph.
D.
with 7
years of experience.
Expertise in the development and qualification and/or validation of H/UPLC (SEC, RP, HILIC, IEX), CE (CE-SDS, icIEF) methodsLarge molecule and protein characterization experienceExperience with biosimilar development and biosimilarity studiesExperience in CMC development teams as an Analytical LeadStrong mentoring, managerial, and leadership skillsStrong oral and written communication skillsExperience with early & late stage regulatory filingsExperience in Team management (3-5 people) & LeadershipPreferred
Qualifications:
Use of liquid-handling automation applicationsExperience with troubleshooting complex instrumentationDirect interactions with FDA and other regulatory agenciesKnowledge of mass spectrometry methodsCharacterization of complex GlycoproteinsExperience with compendial assays (USP, EP, JP)Strength in data science and informaticsThe base pay range for this position at commencement of employment is expected to be $135,000 to $180,000; 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.
SummaryLocation:
RedmondType:
Full time.
Estimated Salary: $20 to $28 per hour based on qualifications.
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