Senior/Principal Scientist, Potency, Functional Biocharacterization and Impurities
Company: Evotec WD
Location: Redmond
Posted on: March 20, 2023
Job Description:
Senior/Principal Scientist, Potency, Functional
Biocharacterization and Impurities page is loaded Senior/Principal
Scientist, Potency, Functional Biocharacterization and Impurities
Apply locations Redmond Seattle time type Full time posted on
Posted 2 Days Ago job requisition id JOB ID-07891 Just is seeking a
motivated and creative senior or 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 assessment and impurity monitoring of
biotherapeutics. - As a key leader in the analytical group, the
successful candidate will have significant experience in cell-based
bioassay, immunoassay, and qPCR -method development, strong
experimental design and data analysis skills, and experience in
method transfer, participation in CMC teams, authoring sections of
regulatory filings, and recruiting, mentoring, developing, and
supervising team members. Previous experience in biosimilar
development, late-stage large molecule development,
qualification/validation and leading CMC teams is highly desirable.
The ideal candidate has strong written and verbal communication
skills, multitasks effectively, exhibits strong leadership skills,
and is excited about ways to improve technology.
Responsibilities:
- Lead and develop a diverse group encompassing all aspects of
biological assay development, including potency and
characterization assays, qualification/validation of potency assays
and method transfer to Quality Control and other Just-Evotec
Biologics sites.
- Collaborate across the organization to speed time to clinic
while reducing development costs
- Manage staff, capital resources and resource planning
- Serve as a technical resource on cross functional teams for
biological characterization
- Author and review technical reports and author documents to
support regulatory filings (including IND, INDa, BLA, IMPD)
- Act as an internal technical resource for Process Design, as
well as a resource and subject matter expert for external clients
and collaborators
- 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
- Supervise and develop the careers for direct reports Required
Qualifications:
- 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, qualification and/or validation
of release potency and impurity methods (cell-based assays,
immunoassays, and qPCR)
- Experience developing and applying early and late state
biological characterization methods (e.g., cell-based assays,
including primary cell assays, SPR or other protein binding kinetic
assays, immunoassays, etc.)
- Experience in areas of technology development pertinent to
impurities and potency assay development, including but not limited
to assay automation and miniaturization, FcgR effector function
assay development, large-scale cell banking, image and flow
cytometry, and monitoring and characterization of diverse
HCP's
- Strong mentoring, managerial, and leadership skills
- Expertise in design of experiments (DOE) and statistical
analysis
- Experience participating in CMC development teams
- Strong oral and written communication skills Preferred
Qualifications:
- Excellent understanding of ICH/USP guidelines on analytical,
impurity, and potency assay development and validation
- Previous experience in biosimilar development
- Significant experience with early & late-stage regulatory
filings
- Experience leading CMC teams 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
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Days Ago About Us Evotec is a life science company with a unique
business model focused on delivering highly effective new
therapeutics to the patients. The Company leverages its
multimodality platform, the "Data-driven R&D Autobahn to
Cures", for proprietary projects and within a network of partners
including Pharma, Biotech, academics, and other healthcare
stakeholders. With more than 4,500 highly qualified people at 17
sites, Evotec aims to create the world-leading co-owned pipeline
for innovative therapeutics. For additional information please go
to www.evotec.com and follow us on Twitter @Evotec and LinkedIn .
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Keywords: Evotec WD, Redmond , Senior/Principal Scientist, Potency, Functional Biocharacterization and Impurities, Other , Redmond, Washington
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