Principal Scientist, Potency and Impurities

3 weeks ago

Seattle, United States Evotec SE Full time

Principal Scientist, Potency and Impurities

Just- Evotec Biologics is seeking a motivated and creative Principal 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 the functional and potency assessment and impurity monitoring of biotherapeutics. As a key member of the analytical development group, the successful candidate will have significant experience in cell-based assays, immunoassays, method development and qualification/validation, as well as strong experimental design and data analysis skills. Previous experience in late-stage and first-in-human (FIH) development, participation in CMC teams, and experience authoring regulatory documents is required. This person would be taking on a leadership role and should have significant experience understanding cell-based and receptor-ligand binding assays. 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 and would be in a role that interfaces directly with clients.

Responsibilities:

* Characterization of early and late stage biotherapeutics using diverse biological assay formats
* Lead and implement method development, DOE robustness, and qualification activities
* Technology transfer to Just- Evotec's Quality Control laboratory
* Participation in process development team(s), including potential for acting as analytical team lead and interfacing both internally and externally to clients
* Technology development to improve throughput and efficiency.
* Author and contribute to documents to support regulatory filings (including IND, INDa, BLA, IMPD)
* Mentor and train junior staff
* Present data to a wide range of audiences, including internal technical development teams, clients, industry conferences, and peer-reviewed journals.
* Lead immunoassay and cell-based potency method development and testing
* Lead cross-functional teams and initiatives.
* Supervise and develop the careers for 1-2 direct reports.

Required Qualifications:

* BS/MS in Biochemistry, Biology, Bioengineering or related field with 15+ years of experience or Ph.D. with 6+years of experience.


* Experience developing analytical methods in a CMC or GMP-like industry setting.


* Excellent understanding of ICH/USP guidelines on analytical, impurity, and potency assay development and validation.


* Experience in the development, DOE robustness, and qualification and/or validation of release potency and impurity methods (immunoassays and qPCR).


* Strong technical understanding of link between MOA and analytical method development, and effects of impurities on biological manufacturing processes.


* Experience in areas of technology development pertinent to impurities and potency assay development, including but not limited to assay automation and miniaturization and monitoring and characterization of diverse HCP's


* Experience developing and applying biological characterization methods (e.g. cell-based assays, SPR/BLI or other protein binding kinetic assays, immunoassays, homogeneous assay formats such as AlphaLISA).



Preferred Qualifications:

* Experience utilizing industry-standard analysis software (e.g. SoftMax Pro, JMP)
* Development of liquid-handling automation applications
* Experience with early & late stage regulatory filings
* Experience with kinetic assay development (SPR, BLI, etc)
* Experience in technology transfer
* Experience participating in CMC teams

The 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.

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