Principal Scientist, Potency and Impurities
Company: Evotec WD
Location: Seattle
Posted on: November 13, 2024
Job Description:
Principal Scientist, Potency and Impurities 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
$140,000 to $170,000; 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.At
Evotec, we support internal development and therefore we encourage
all colleagues to apply to internal opportunities. Are you ready
for the next internal career step? Dare to dream!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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Keywords: Evotec WD, Edmonds , Principal Scientist, Potency and Impurities, Other , Seattle, Washington
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