Senior Scientist or Associate Principal Scientist, LBA Platform Crystal Pharmatech Inc - 2.0 Pleasanton, CA Job Details Full-time $120,000 - $165,000 a year 10 hours ago Qualifications Molecular biomarkers Immunological laboratory techniques Pharmaceutical company experience Clinical quality assurance standards

Full Job Description Position Summary:

Crystal Bio Solutions is a CRO providing global-standard services in

GLP/GCLP

bioanalysis and biomarker. Our clients include multinational pharmaceutical companies and biotech companies. The Bioanalysis & Biomarkers Department specializes in Method Development, Method Validation, GLP/GCLP Bioanalysis for PK, immunogenicity and biomarkers. The team has successfully supported non-GLP, GLP (non-clinical) and GCLP (clinical) projects. The role is responsible for providing bioanalytical support for both pre-clinical and clinical projects and partnering with our clients for project success.

Key Responsibilities:

Independently propose assay design and/or strategy, develop,validate, conduct, and troubleshoot bioanalytical methods, includingPK, Immunogenicity(ADA andNAb)and Biomarker,forGLP/GCLPsample testing and data reporting. Present and interpret data internally and/or externally as needed. Serve as the Principal Investigator responsible for interaction with the client from the studydesign to scheduling, conducting, reporting, and transferringdata. Ensure responsiveness to the client,timelydelivery, and overall customer satisfaction. Serve as Subject Matter Expert (SME)for LBA (ELISAmultimodereader& Meso-Scale Discovery (ECL)). Author and/or reviewkey regulatory documents,validationplansand reports, laboratory data, and technical reports. Provideoversight of the laboratory, mentor junior staff, and collaborate to keep improving operational excellence. Assistinestablishingand improving policies,procedures, workinstructionsand SOPs. Understand and adhere to corporate standardsregardingcode of conduct, Environment Health & Safety(EHS), and

GLP/GCP/GDP

compliance. Perform other related duties as assigned.

Qualifications & Educational Requirements:

Ph.D.,M.Sc., M.A., B.A., in Biology, Immunology,Chemistry, Pharmacology, or other related scientific fieldsrequired, including a minimum of4+(Ph.D.),9+(Master's)or12+(Bachelor's)years of Pharma/Biotech/CRO experience. Understanding and experience inCROprocess andbusinessmodelarerequired Hands-on experience and strong knowledge ofGLP/GCLPbioanalysis. Experience inLBA-basedMethod Development, ValidationforPK,Immunogenicity (ADA,NAb)and PD Biomarkerassays. An extensive knowledge of Immunogenicity Method Development, Validation and Sample Analysis is highly desirable. Previousexperience withflow cytometry andcell-based assaysforNAband biomarker applications is a plus Experience with Watson LIMSandinCROenvironmentispreferred. Supervisory experience in both project andtalent (people)managementis preferred. Ability to work independently and pay good attention to details. Ability to achieve objectives/timelines through collaborative efforts with co-workers, managers, and clients. Must be goal-oriented, compliance-ensured, quality-conscientious, and client/timeline-focused. Effective writing and communication skills. The salary range represents the anticipated base pay for this position. Actual compensation may vary based on factors including, but not limited to, skills, qualifications, experience, education, and location. As part of our recruitment process, we may use technology-assisted tools to support application review and improve efficiency. All hiring decisions are made by our team.