Senior Scientist or Associate Principal Scientist, LBA Platform

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.