Analytical Scientist
Company: Valentia Analytical
Location: Fremont
Posted on: July 18, 2025
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Job Description:
About Valentia Analytical: Valentia Analytical is a
GMP-compliant contract testing laboratory specializing in advanced
analytical characterization for the Pharmaceutical,
Biotechnological, and Cell and Gene Therapy industries. With core
capabilities in chromatography (HPLC/UPLC), electrophoresis
(CE/iCIEF), Bioassays, ELISAs, and digital PCR, Valentia supports
drug developers through method development, validation, GMP release
and stability testing, and regulatory filings. Position Overview:
Valentia Analytical is seeking a skilled and motivated Scientist to
join our growing analytical team. The successful candidate will
support and lead projects involving method development, method
qualification/validation, and testing of biologics, small
molecules, and antibody-drug conjugates (ADCs). This is a hands-on
role working across a variety of platforms, including
chromatographic, electrophoretic, and immunological methods, to
support CMC activities and regulatory submissions. Key
Responsibilities: Develop and validate analytical methods (e.g.,
RP-HPLC, SEC, IEC, CE-SDS, iCIEF, ELISA, ddPCR, Bioassays, ELISA).
Execute GMP-compliant testing for release, stability,
comparability, and characterization studies. Design and perform
investigative studies on a variety of compounds. Troubleshoot
technical challenges in methods or instrumentation. Write and
review protocols, reports, SOPs, and regulatory documentation
Collaborate cross-functionally with QA, clients, and project
management. Support training and mentorship of junior analysts.
Maintain rigorous documentation practices in compliance with GMP
and ISO17025 standards. Preferred Qualifications: M.S. or Ph.D. in
Analytical Chemistry, Biochemistry, or related discipline. 3 years
of experience in a regulated (GMP or ISO) laboratory, preferably in
a CRO or pharmaceutical/biotech environment. Hands-on experience
with HPLC/UPLC, CE, and immunoassay platforms. Experience working
with biologics, ADCs, or gene therapy products is highly desirable.
Strong knowledge of FDA and ICH guidelines related to analytical
testing and method validation. Strong working knowledge of Waters
Empower Chromatographic Data Systems. Excellent technical writing
and data interpretation skills. What We Offer: Exposure to
cutting-edge biologic and gene therapy product testing Opportunity
to grow with a fast-paced and collaborative team Professional
development and leadership opportunities
Keywords: Valentia Analytical, Union City , Analytical Scientist, Science, Research & Development , Fremont, California
