Scientist /Sr Scientist/ Associate Principal Scientist, LCMS Platforms jobs in United States
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Crystal Bio Solutions, a member of Crystal Pharmatech · 2 months ago

Scientist /Sr Scientist/ Associate Principal Scientist, LCMS Platforms

positionPleasanton, CA 94566
timeFull-time
remoteOnsite
seniorityMid, Senior Level, Lead/Staff
money$110K/yr - $160K/yr
date4+ years exp

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 and partnering with clients for project success.

BiotechnologyClinical TrialsHealth CareLife Science
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H1B Sponsor Likelynote

Responsibilities

Independently propose assay design and/or strategy, develop, validate, conduct, and troubleshoot LCMS-based bioanalytical methods for the quantification of small molecule (and its metabolites) and biologics (e.g. ADC, mAB, protein, peptide, oligonucleotide etc) in support of PK, and Biomarker measurement
Conduct or oversee GLP/GCLP sample analysis 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 LCMS platform
Ensure GLP/GCLP compliance, including accurate documentation and adherence to established procedures
Author and/or review key regulatory documents, validation plans and reports, laboratory data, and technical reports
Provide technical leadership for LC-MS as a Subject Matter Expert, and mentor junior scientists
Assist in 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

GLP/GCLP bioanalysisLCMS method developmentLIMSQMS systemsLarge molecule LCMS analysisBioanalytical platformsSupervisory experienceTeam collaborationEffective communication

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 CRO/Pharma/Biotech experience
Hands-on experience and strong knowledge of GLP/GCLP bioanalysis
Experienced with GLP/GCLP LCMS method development and validation for PK and/or biomarker analysis
Functional experience utilizing LIMS and QMS systems for GLP/GCLP bioanalysis
Established record of independent achievement of objectives and timelines while maintaining high work quality
Effective in team environments co-workers, managers, and clients
Must be goal-oriented, compliance-ensured, quality-conscientious, and client-focused
Effective writing and communication skills are required

Preferred

Experience in large molecule LCMS analysis (e.g. ADC, mAB, protein, peptide, oligonucleotide etc) preferred
Familiarity with additional bioanalytical platforms (e.g. LBA, PCR, Flow Cytometry) preferred
Supervisory experience in both project and talent (people) management is preferred

Benefits

401(k)
401(k) matching
Bonus based on performance
Dental insurance
Free food & snacks
Health insurance
Paid time off
Parental leave
Vision insurance

Company

Crystal Bio Solutions, a member of Crystal Pharmatech

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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.
dateFounded in 2018
location
Pleasanton, California, USA
people-size201-500 employees
web-link
https://amadorbioscience.com

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 Stage
Total Funding
$60M
Key Investors
MSA Capital
2021-12-30Series B· $60M
2021-09-28Series B

Leadership Team

M
Meina Liang
Chief Technology Officer (CTO), President of Bioanalysis & Biomarkers
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Recent News

BioBuzz
Associate Director, Laboratory Operations in Pleasanton, California
2024-02-11
Amador Biologics, a translational science and clinical pharmacology CRO, announced the completion of B+ round financing of more than 60 million US dollars
2023-07-03
PRNewswire
Amador Bioscience Welcomes Dr. Lorin Roskos as Chief Scientific Officer and President of Quantitative Clinical Pharmacology
2023-05-05
Company data provided by crunchbase