Job Search
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BioAgilytix Boston, 1320 Soldiers Field Road, Boston, MA, USA ● Req #66Wednesday, November 23, 2022Essential Responsibilities Develop and validate biomarker, cell-based, immunogenicity, immuno- and enzymatic assays for support of preclinical, clinical and product release studies Work closely with clients to assure successful on time execution of assays, validation and sample analysis under GxPs Design and execute experiments efficiently Conduct routine analysis Present data and posters Perform statistical analysis Write reports and prepare SOPs ...Read more about Principal Investigator (PI)More
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BioAgilytix Boston, 1320 Soldiers Field Road, Boston, MA, USA ● Req #266Tuesday, November 22, 2022In this role, you are responsible for GxP-compliant management of incoming and outgoing biological samples. Our clients trust us to deliver excellence in data and bioanalysis, and this position is a foundational piece of our larger process. Our company exists to test samples, and you will ensure the samples are checked into our Laboratory Information Management System (LIMS), managed according to our procedures, and available to our scientific teams on time. We are looking for candidates ...Read more about Sample Management TechnicianMore
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BioAgilytix San Diego, 9050 Camino Santa Fe, San Diego, CA, USA ● Req #264Monday, November 21, 2022In this San Diego onsite role, the Sample Management Technician is responsible for GxP-compliant processing of incoming samples and reference materials. Essential Responsibilities Accessions samples into LIMS Imports electronic sample data into eSMS Provides timely notification of sample receipt to appropriate client/study personnel as needed Maintains sample chain-of-custody Reviews study sample demographic data to confirm consistency between sample labels, st ...Read more about Sample Management Technician - San DiegoMore
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BioAgilytix San Diego, 9050 Camino Santa Fe, San Diego, CA, USA ● Req #240Sunday, November 20, 2022The Clinical Kit Coordinator coordinates the assembly and release of clinical kits to meet client expectations and maintain a high level of quality through communication, customer service, and organizational practices. Essential Responsibilities Performs and maintains documentation and compliance standards with adherence to USFDA, OECD, and MHLW Good Laboratory Practices regulations as required Reviews protocols to determine type of kit needed (i.e., timepoints, anticoagulant, v ...Read more about Clinical Kit CoordinatorMore
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BioAgilytix Labs, 2300 Englert Drive, Durham, NC, USA ● Req #259Wednesday, November 16, 2022The Director/ Sr. Director, HRBP, is the senior HR Business partner for the Durham location (close to 600 employees), and our global headquarters. Our other locations are in Boston, San Diego, Hamburg, Germany, and Melbourne, Australia. This person will partner with the leaders and employees at the Durham site to build and drive a compelling talent and culture strategy that is congruent with our employee value proposition that BioAgilytix is a great place for scientists to build and nurture a ca ...Read more about Director, Human Resources Business PartnerMore
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BioAgilytix Labs, 2300 Englert Drive, Durham, NC, USA ● Req #243Wednesday, November 16, 2022The Proposal Writer / Commercial Liaison assists in all aspects of quote, budget, and proposal generation. We are looking for candidates who have experience in a corporate GxP setting. This role is not lab-based, but our best candidates have lab experience or experience with the types of assays we do here. You are self-motivated, an independent thinker, and highly detail oriented. Essential Responsibilities Generates draft proposals and budgets for assigned opportunities, while unde ...Read more about Proposal WriterMore
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BioAgilytix Labs, 2300 Englert Drive, Durham, NC, USA ● Req #260Friday, November 11, 2022Essential Responsibilities Study Administration - Contracts & Amendments Assists with inputting proposals and amendments into SalesForce Assists with tracking opportunities that are being created for new proposals Assists with the organization of activities required to achieve data submission/client deliverable timelines for multiple projects and clients Actively collaborates with Bioanalytical Project Managers (BPM), other Operations team members, Quality Control (QC) ...Read more about Business Development CoordinatorMore
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BioAgilytix Labs, 2300 Englert Drive, Durham, NC, USA ● Req #134Wednesday, November 9, 2022Essential Responsibilities Serves as lead scientist on assay development, validation, and sample analysis project for support of CMC characterization, stability and release testing Follows GMP guidelines for method validation and sample analysis Independently writes plans and reports for validation and sample analysis Responsible for prompt identification, submission, notification, and review of deviations Designs and runs assay run independently Analyzes, i ...Read more about Scientist (CMC/GMP)More
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BioAgilytix Boston, 1320 Soldiers Field Road, Boston, MA, USA ● Req #198Tuesday, November 8, 2022In this role, you will lead the development and validation of Biomarker assays to bring new therapies to market. This role is never boring due to our wide variety of clients and broad ranges of medicine treating different types of diseases. You’ll work in a milestone driven environment generating data, evaluating the performance of the medicine and context of use. Data integrity and quality are important to us, and this role will integrate the expectations in a highly regulated setting.We are lo ...Read more about Scientist - Biomarker - BostonMore
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BioAgilytix Europe GmbH, Lademannbogen 10, Hamburg, DE-HH, DEU ● Req #88Sunday, November 6, 2022Ihre Aufgabengebiete: Planung, Durchführung und initiale Auswertung immunologischer Testverfahren im Labor (z. B. ECL, ELISA, zell-basierte Assays) Akkurate Dokumentation von Versuchsplanung und Ergebnissen nach GxP Beteiligung als Analyst in verschiedenen regulierten Studienphasen (Validierung, Probenanalyse nach GLP/GCP) Erstellen von technischen Standardarbeitsanweisungen (SOPs) Beteiligung am Troubleshooting von Assays Ansetzen von Puff ...Read more about Technischer Assistent / Analyst / Laboratory Technician (m/f/d) in VollzeitMore
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BioAgilytix Labs, 2300 Englert Drive, Durham, NC, USA ● Req #253Friday, November 4, 2022Our clients trust us to deliver excellence in data and bioanalysis and in this role and you will be a critical part of our beginning-to-end client data quality processes. Through your technical reviews of raw and processed data, you will ensure data integrity standards are met across various equipment, regulatory settings, and workflows. You are the bridge between the lab and the quality assurance team, combining observations on regulatory requirements with your knowledge of plate-based assays, ...Read more about Data Reviewer (QC Specialist)More
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BioAgilytix Labs, 2300 Englert Drive, Durham, NC, USA ● Req #148Friday, November 4, 2022Essential Responsibilities Develop and validate biomarker, cell-based, immunogenicity, immuno- and enzymatic assays for support of preclinical, clinical and product release studies Work closely with clients to assure successful on time execution of assays, validation and sample analysis under GxPs Design and execute experiments efficiently Conduct routine analysis Present data and posters Perform statistical analysis Write reports and prepare SOPs ...Read more about Principal Investigator (GCT) - DurhamMore
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BioAgilytix Labs, 2300 Englert Drive, Durham, NC, USA ● Req #230Friday, November 4, 2022We are looking for candidates who get energized by working with the newest bioanalytical technologies to solve complex challenges. The best candidates are curious and continuous learners, who have experience in a highly regulated environment, where data integrity is expected and honored. You’ll enjoy and crave collaboration with a network of expert scientists, all while welcoming the opportunity to manage multiple projects, sponsors and project timelines. If you are adaptable and able to inspire ...Read more about Scientist (LC/MS)More
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BioAgilytix Boston, 1320 Soldiers Field Road, Boston, MA, USA ● Req #221Friday, November 4, 2022BioAgilytix is a leading contract research organization (CRO) providing fully integrated laboratory services worldwide. Our global team of professionals in Durham, North Carolina; Boston, Massachusetts; San Diego, California, Melbourne, Australia, and Hamburg, Germany bring a passion for helping biopharma companies achieve more for the patients they serve.As a division within our BioAgilytix Boston facility, BioAgilytix Diagnostics is CLIA-certified, CAP-accredited, New York State licensed clin ...Read more about Medical TechnologistMore
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BioAgilytix Boston, 1320 Soldiers Field Road, Boston, MA, USA ● Req #218Friday, November 4, 2022Essential ResponsibilitiesProvide strategic and managerial oversight of bioanalytical operations including overseeing bioanalytical method development, validation, and sample analysis in support of peptides, hormones and proteins (biomarker, cell-based, PK, immunogenicity, immuno-, and enzymatic assays), bioanalytical project management, and bioanalytical material/instrument managementManage bioanalytical operations departments (up to 18 people) through a team of functional managers and front-li ...Read more about Associate Director, ImmunogenicityMore
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BioAgilytix Boston, 1320 Soldiers Field Road, Boston, MA, USA ● Req #62Friday, November 4, 2022Our clients trust us to deliver excellence in data and bioanalysis and in this role and you will be a critical part of our beginning-to-end client data quality processes. Through your technical reviews of raw and processed data, you will ensure data integrity standards are met across various equipment, regulatory settings, and workflows. You are the bridge between the lab and the quality assurance team, combining observations on regulatory requirements with your knowledge of plate-based assays ...Read more about Data Reviewer (QC)More
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BioAgilytix Boston, 1320 Soldiers Field Road, Boston, MA, USA ● Req #70Friday, November 4, 2022In this role, you will champion quality and compliance in our solutions. Our clients trust us to deliver excellence in data and bioanalysis, and this role is the last destination before our data is delivered. You will ensure standard methods and protocol requirements are met through thorough monitoring and audits. Partnering with the Operations team, you will review key procedures in a GxP environment, highlight any gaps or deviations in approach, then advise on corrective action, which leads us ...Read more about Senior QA AuditorMore
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BioAgilytix San Diego, 9050 Camino Santa Fe, San Diego, CA, USA ● Req #101Friday, November 4, 2022Our clients trust us to deliver excellence in data and bioanalysis and in this San Diego onsite role and you will be a critical part of our beginning-to-end client data quality processes. Through your technical reviews of raw and processed data, you will ensure data integrity standards are met across various equipment, regulatory settings, and workflows. You are the bridge between the lab and the quality assurance team, combining observations on regulatory requirements with your knowledge of pla ...Read more about Data Reviewer (QC)More
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BioAgilytix Boston, 1320 Soldiers Field Road, Boston, MA, USA ● Req #96Friday, November 4, 2022In this role, you will lead the development and validation of molecular assays to bring novel gene and cell therapies to market. This role is never boring due to our wide variety of clients and broad ranges of medicine treating different types of diseases. You’ll work in a milestone driven environment generating data, evaluating the performance of the medicine and context of use. Data integrity and quality are important to us, and this role will integrate the expectations in a highly regulated s ...Read more about Scientist (Gene and Cell Therapy)More
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BioAgilytix Boston, 1320 Soldiers Field Road, Boston, MA, USA ● Req #66Friday, November 4, 2022Essential Responsibilities Develop and validate biomarker, cell-based, immunogenicity, immuno- and enzymatic assays for support of preclinical, clinical and product release studies Work closely with clients to assure successful on time execution of assays, validation and sample analysis under GxPs Design and execute experiments efficiently Conduct routine analysis Present data and posters Perform statistical analysis Write reports and prepare SOPs ...Read more about Principal Investigator (PI)More
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BioAgilytix Boston, 1320 Soldiers Field Road, Boston, MA, USA ● Req #2Friday, November 4, 2022In this role, you will perform validation studies through the analysis of biological samples. Our clients trust us to deliver excellence in data and bioanalysis, and this role is a bedrock within our project lifecycle. You will work on a wide variety of sample validations, including biologics, protein, peptides, small molecules, and/or biomarkers with a team of expert scientists. This role is also exposed to a range of analytical instrumentation and each project looks different than the previous ...Read more about AnalystMore
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BioAgilytix Labs, 2300 Englert Drive, Durham, NC, USA ● Req #252Thursday, November 3, 2022In this role, you will partner with our Principal Investigators or Bioanalytical Project Managers (BPMs) to manage every stage of our projects, from start to finish. The Study Coordinator role is the foundation for managing client projects and scientific execution in an efficient manner. You’ll experience a broad range of responsibilities, spanning study administration, data management and client communications. We are looking for candidates who get energized by complicated bioanalytic challenge ...Read more about Study CoordinatorMore
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BioAgilytix Labs, 2300 Englert Drive, Durham, NC, USA ● Req #251Wednesday, November 2, 2022In this role, you will perform validation studies through the analysis of biological samples. Our clients trust us to deliver excellence in data and bioanalysis, and this role is a bedrock within our project lifecycle. You will work on a wide variety of sample validations, including biologics, protein, peptides, small molecules, and/or biomarkers with a team of expert scientists. This role is also exposed to a range of analytical instrumentation and each project looks different than the previous ...Read more about AnalystMore
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BioAgilytix Labs, 2300 Englert Drive, Durham, NC, USA ● Req #256Tuesday, November 1, 2022We are looking for a responsible Administrative Assistant to perform a variety of administrative and clerical tasks. Duties of the Administrative Assistant include providing support to our managers and employees, assisting in daily office needs and other general administrative activities. Essential ResponsibilitiesLiaise with administrative team to handle requests and queries from senior managementCreate and distribute high-quality written communications (email, correspondence memos, letters ...Read more about Administrative AssistantMore
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BioAgilytix San Diego, 9050 Camino Santa Fe, San Diego, CA, USA ● Req #234Monday, October 24, 2022Essential ResponsibilitiesResponsible for partnering with internal stakeholders to define and monitor project timelinesMaintains close communications with internal and external stakeholders to ensure that projects remain on schedule and appropriately resourcedMaintains a strong working relationship and open communications with Quality Control, Quality Assurance, and Sample ManagementMaintains Microsoft Project Gantt charts and supports documentation for individual projectsMonitors project timeli ...Read more about Project Manager - San DiegoMore