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  • BioAgilytix Labs, 2300 Englert Drive, Durham, NC, USA ● Req #292
    Friday, January 27, 2023
    You will manage numerous workstreams to deliver against project objectives successfully and in a timely manner. You will work closely on many technical parts of these projects, overseeing upgrades and implementation of systems and software. Essential Responsibilities Responsible for authoring Project Plans, Project Charters, Statements of Work, Resource Plans, Risk Assessments, and Testing Plans for a variety of enterprise-level, global projects including on-prem and cloud-based so ... More
  • BioAgilytix Labs, 2300 Englert Drive, Durham, NC, USA ● Req #291
    Friday, January 20, 2023
    The Payroll Manager is responsible for ensuring adherence to the Company’s policies, setting, and overseeing accurate and timely payroll processing, and ensuring payroll activities are appropriately recorded in the general ledger. He or she will build and maintain strong business relationships, display excellent organizational skills, continuously improve process efficiencies, and is expected to maintain a high level of confidentiality. Essential Responsibilities: Implements, main ... More
  • BioAgilytix Europe GmbH, Lademannbogen 10, Hamburg, DE-HH, DEU ● Req #290
    Wednesday, January 18, 2023
    The Business Development (BD) Associate is responsible for supporting the Business Development team.  The primary responsibility of the BD Associate is to research and establish initial contact with prospect companies, setting meetings, and teleconferences for the BD team through cold calling and personalized email messages. He or she will assist the Business Development team with data collection, compilation, research, records maintenance, and other reporting. and engage them through cold outre ... More
  • BioAgilytix Europe GmbH, Lademannbogen 10, Hamburg, DE-HH, DEU ● Req #227
    Wednesday, January 18, 2023
    Essential Responsibilities   Company-Facing: Serve as scientific and regulatory advisor to the Company's Operations team (for current projects) and BD team (for proposed projects) Develop and conduct relevant internal scientific and regulatory training curriculum for Operations, BD and Quality team membersAssist the Company’s BPMs/PIs to publish / present their results, including through obtaining Sponsor approval to share dataAssist BD, Operations and Human Resources in identifying and eval ... More
  • BioAgilytix Labs, 2300 Englert Drive, Durham, NC, USA ● Req #230
    Friday, January 13, 2023
    We 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 ... More
  • BioAgilytix San Diego, 9050 Camino Santa Fe, San Diego, CA, USA ● Req #98
    Friday, January 6, 2023
    In this role, you will apply your real-world, expert insight to help our customers successfully navigate the complexities of large molecule bioanalysis. This role is the singular scientific expert and main contact for our clients through every stage of the project lifecycle. You are also a teacher, mentor and coach to the BioAgilytix project team providing day-to-day leadership both in and out of the lab. Our clients trust us to deliver accurate and reliable results, and this role provides the c ... More
  • BioAgilytix San Diego, 9050 Camino Santa Fe, San Diego, CA, USA ● Req #79
    Friday, January 6, 2023
    In this San Diego onsite role, you will lead the design, development, and execution of bioanalytical experiments to bring new therapies to market. This role is very exciting 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 ... More
  • BioAgilytix San Diego, 9050 Camino Santa Fe, San Diego, CA, USA ● Req #240
    Friday, January 6, 2023
    The 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 ... More
  • BioAgilytix San Diego, 9050 Camino Santa Fe, San Diego, CA, USA ● Req #284
    Friday, January 6, 2023
    Essential Responsibilities Manage inbound samples and sample documentation received. Resolve sample discrepancies and maintain accurate study records. Support Client Specific Metrics May support sample management activities Support end of study activities Track Long Term Stability Timepoints Support sponsor sample reconciliation Maintain tracking of project samples received, tested, and reported. Support data table generation Assist in the submission of data and reports for Qualit ... More
  • BioAgilytix San Diego, 9050 Camino Santa Fe, San Diego, CA, USA ● Req #264
    Friday, January 6, 2023
    In 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 ... More
  • BioAgilytix Boston, 1320 Soldiers Field Road, Boston, MA, USA ● Req #221
    Thursday, January 5, 2023
    The Medical Technologist in our BioAgilytix Boston facility is responsible for performing high complexity Clinical Diagnostic patient testing and clinical trial testing covered under CLIA. As a division within our BioAgilytix Boston facility, BioAgilytix Diagnostics is CLIA-certified, CAP-accredited, New York State licensed clinical diagnostic testing facility providing esoteric testing services to the top reference laboratories and supporting clinical trial testing.  Essential Responsibil ... More
  • BioAgilytix Labs, 2300 Englert Drive, Durham, NC, USA ● Req #287
    Thursday, December 29, 2022
    In 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 ... More
  • BioAgilytix Labs, 2300 Englert Drive, Durham, NC, USA ● Req #279
    Friday, December 16, 2022
    The Corporate Compliance Manager (Vendor Quality) is responsible for providing quality assurance (QA) oversight within the Quality Management System (QMS). He or she ensures Corporate and vendor-provided GxP activities are compliant with national/international GxPs. The Corporate Compliance Manager may also be responsible for leading and managing a team that supports the BioAgilytix (BAL) QMS. Essential ResponsibilitiesManages BAL Vendor Assessment and oversight and addresses quality and compli ... More
  • BioAgilytix Europe GmbH, Lademannbogen 10, Hamburg, DE-HH, DEU ● Req #275
    Friday, December 9, 2022
    This role is ingrained within our bioanalytical technology teams, providing a variety of project management support through all phases of our client services. You will be the glue connecting our internal functions to the actions required of an efficient and quality-driven project process. This role also works closely with the scientific leads, business functions, and supporting staff in the delivery of sponsored projects. You will monitor workflow and resourcing, revenue recognition and forecast ... More
  • BioAgilytix Labs, 2300 Englert Drive, Durham, NC, USA ● Req #246
    Tuesday, December 6, 2022
    This role is ingrained within our bioanalytical technology teams, providing a variety of project management support through all phases of our client services. You will be the glue connecting our internal functions to the actions required of an efficient and quality-driven project process. This role also works closely with the scientific leads, business functions, and supporting staff in the delivery of sponsored projects. You will monitor workflow and resourcing, revenue recognition and forecast ... More
  • BioAgilytix Europe GmbH, Lademannbogen 10, Hamburg, DE-HH, DEU ● Req #203
    Monday, December 5, 2022
    Hervorragende Wissenschaft erfordert großartige Mitarbeiter. Sie sind Buchhalter (m/f/d), Finanzbuchalter (m/f/d), oder kaufmännischer Mitarbeiter (m/f/d) und suchen eine neue Herausforderung als Financial Accountant (m/f/d) in Teilzeit bei 30 Stunden? Dann sucht unser Finanz-Team genau Sie, als Unterstützung in der Kreditorenbuchhaltung und den folgenden Aufgaben:   Ihre Aufgabengebiete: Prüfen, Kontieren und Verbuchen von Eingangsrechnungen Führen der Kreditore ... More
  • BioAgilytix Europe GmbH, Lademannbogen 10, Hamburg, DE-HH, DEU ● Req #116
    Monday, December 5, 2022
    Ihre Aufgabengebiete: Technische, wissenschaftliche Überprüfung der analytischen Ergebnisse (Qualitätskontrolle, QC) Überprüfung der Daten in den Zusammenfassungen, Berichten und Berechnungen Dokumentation der Überprüfungsergebnisse Enge Zusammenarbeit mit den Wissenschaftlern, Mitarbeitern aus dem Labor und der Qualitätssicherung Verantwortlich für die Einhaltung unserer Qualitätsstandards Dokumentation von Abweichungen von Qualitätsstanda ... More
  • BioAgilytix Boston, 1320 Soldiers Field Road, Boston, MA, USA ● Req #267
    Friday, December 2, 2022
    In 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 ... More
  • BioAgilytix Boston, 1320 Soldiers Field Road, Boston, MA, USA ● Req #66
    Wednesday, November 23, 2022
    Essential 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 ... More
  • BioAgilytix Boston, 1320 Soldiers Field Road, Boston, MA, USA ● Req #266
    Tuesday, November 22, 2022
    In 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 ... More
  • BioAgilytix Boston, 1320 Soldiers Field Road, Boston, MA, USA ● Req #198
    Tuesday, November 8, 2022
    In 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 ... More
  • BioAgilytix Europe GmbH, Lademannbogen 10, Hamburg, DE-HH, DEU ● Req #88
    Sunday, November 6, 2022
    Ihre 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 ... More
  • BioAgilytix Labs, 2300 Englert Drive, Durham, NC, USA ● Req #253
    Friday, November 4, 2022
    Our 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, ... More
  • BioAgilytix Labs, 2300 Englert Drive, Durham, NC, USA ● Req #148
    Friday, November 4, 2022
    Essential 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 ... More
  • BioAgilytix Boston, 1320 Soldiers Field Road, Boston, MA, USA ● Req #218
    Friday, November 4, 2022
    Essential 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 ... More