Crystal Bio Solutions, a member of Crystal Pharmatech · 14 hours ago
Sr or Associate Principal Scientist Flow_PCR_Elispot Platforms
Crystal Bio Solutions is a CRO providing global-standard services in GLP/GCLP bioanalysis and biomarker. The role is responsible for providing bioanalytical support for both pre-clinical and clinical projects, ensuring client satisfaction and operational excellence.
BiotechnologyClinical TrialsHealth CareLife Science
Responsibilities
Independently propose assay design and/or strategy, develop, validate, conduct, and troubleshoot bioanalytical methods, including PK, and Biomarker, for GLP/GCLP sample 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 study design to scheduling, conducting, reporting, and transferring data. Ensure responsiveness to the client, timely delivery, and overall customer satisfaction
Serve as Subject Matter Expert (SME) for FLOW Cytometry
Author and/or review key regulatory documents, validation plans and reports, laboratory data, and technical reports
Provide oversight of the laboratory, mentor junior staff, and collaborate to keep improving operational excellence
Assist in establishing and improving policies, procedures, work instructions and SOPs
Understand and adhere to corporate standards regarding code of conduct, Environment Health & Safety (EHS), and GLP/GCP/GDP compliance
Perform other related duties as assigned
Qualification
Required
Ph.D., M.Sc., M.A., B.A., in Biology, Immunology, Chemistry, Pharmacology, or other related scientific fields required, including a minimum of 4+(Ph.D.), 9+(Master's) or 12+(Bachelor's) years of Pharma/Biotech/CRO experience
Hands-on experience and strong knowledge of GLP/GCLP bioanalysis
Experience in Flow Method Development, Validation for PK, and PD Biomarker assays
Knowledge and hands on experience in one or more of the following assay platforms, Cell-Based Assays, qPCR, dPCR, ELISpot, are highly desirable
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-focused
Effective writing and communication skills
Preferred
Supervisory experience in both project and talent (people) management is preferred
Benefits
401(k)
401(k) matching
Bonus based on performance
Dental insurance
Health insurance
Paid time off
Parental leave
Vision insurance
Wellness resources
Company
Crystal Bio Solutions, a member of Crystal Pharmatech
Crystal Bio Solutions is a U.S.-based CRO providing integrated Analytical, Bioanalytical, Biomarker, and Quantitative Clinical Pharmacology (QCP) services that accelerate drug development from discovery to clinic.
H1B Sponsorship
Crystal Bio Solutions, a member of Crystal Pharmatech has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2023 (3)
2022 (2)
2020 (1)
Funding
Current Stage
Growth StageTotal Funding
$60MKey Investors
MSA Capital
2021-12-30Series B· $60M
2021-09-28Series B
Recent News
2024-02-11
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