Aurobac Tx
Associate Director Bioanalytical Sciences (ATX24-03)
Aurobac Tx, Jackson, Mississippi, United States,
Associate Director Bioanalytical Sciences (ATX24-03)
As Associate Director Bioanalytical Sciences at AUROBAC, you will be responsible of analytical testing and bioanalysis for preclinical studies and clinical trials conducted in programs of AUROBAC TX portfolio. This includes:- Leading the experimental design, method/assay development and validation, execution and monitoring of bioanalysis of non-clinical and clinical biomarkers, as well as small molecule or biological drug candidate concentrations in biological tissues, whole blood/plasma/ serum/urine with sufficient rigor to meet regulatory compliance and standards- Drafting RFPs and screening CRO/partner capabilities and performance, reviewing and approving vendor SOWs, quotes, establish agreements and bids, establishing credible vendor relationships to support and meet Aurobac program objectives, timelines and milestonesYou will report to the Chief Development Officer (and Chief Medical Officer for clinical work), in close collaboration with AUROBAC TX Research and Clinical Development team.Published on
19 Jul 2024Missions1. Design, Implementation, Monitoring and Control of Developments and Analyses, in Conjunction with Research and Clinical TeamsWork directly with CDO as well as Research and Clinical Development teams to participate in the development of biomarker strategies as well as assay method and validation, and support of transcriptomic/proteomic analyses as well as pharmacokinetic/toxicokineticDefine requirements and specifications for any bioanalytical sciences activity and implement execution– bioanalysis method/assay of non-clinical and clinical biomarkers,– small molecule or biological drug candidate concentrations in biological tissues, whole blood/plasma/serum/urineCoordinate with Research and Clinical Team to ensure sample generation, processing, and storage equipment is available, in satisfactory working condition, and in compliance with assay protocol and laboratory SOPsReview method and protocol development supporting assay validation. Review of formal assay validation documents, laboratory /pharmacy manual and study plan contributions to clinical study protocols and data management interfaceEnsure reliable bioanalytical data transfer of exploratory and/or GLP compliant clinical sample concentrations to team members involved with biomarker development, toxicokinetic, pharmacometrics, and PK/PD analysisMonitor, alert on possible deviations, proposing solutions and implement and follow-up of contingency plans to achieve set objectivesWrite/Review/Validate reports – in compliance with filing and archiving procedures for GLP, GCP and additions to Trial Master File (TMF)2. Management of Bioanalytical Sciences External Partners (CRO, Clinical Laboratories, Other External Stakeholders and Experts) and biobanking PartnersDraft calls for tenders and bidding processes involving CRO/partner selectionReview technical and financial proposals, verify that service providers’ activities are in line with the terms of the contract and specificationsEstablish contract and working relationships with partners and investigators associated with biomarker and drug candidate bioanalysis inclusive of clinical, non-clinical, ex-vivo, and in -vitro samplesPrepare audits of partner laboratories involved with GLP toxicology and clinical study sample bioanalysis and implementation of corrective actions if necessary and follow-up of requested actions until their resolution in collaboration with Quality AssurancePropose and implement solutions for optimal monitoring of the sample bank and participate in the evaluation and arbitration of sample conservation choices for various pre-clinical and clinical projects3. Budget ManagementEvaluate and propose forecast costs to executive team for bioanalytical sciences activitiesMonitor budget, anticipate deviations and necessary alerts to CDO. Propose cost adjustments where applicablePropose, for the duration of the study or trial, ad hoc solutions and/or contingency plans to be implemented in the event of qualitative and quantitative deviationsPersonal skillsFluency in English is a must-have, French language skills would be a major plus.Familiarity and experience with small molecule, biological, and proteomic analysis of biological matrices utilizing LC/MS/MS or related analytical expertise. Additional experience with transcriptomic and immuno-quantitative approaches utilizing RT-PCR, FACS and FITC preferred.Experience and familiarity with regulatory guidance pertaining to validation of bioanalytical assays utilizing Good Laboratory Practices (GLP), Compliance with handling and transfer requirements of human derived tissues and reagents (HIPA, Informed consent and archive storage compliance).Experience with bioanalytical method development process including an understanding of determining linear range of assay, utilization of non-linear regression (as needed), establishing lower and upper limits of quantification, creation of standard curves, use of fortified standards and internal standards for calibration, creation of QC, freeze/thaw stability and dilution integrity standards.Detail-oriented with strong organizational and project management skills. problem-solverStrong in both strategic thinking and day-to-day execution to achieve operational excellence.Professional experienceA Bachelor’s or Master’s degree (PhD preferred) in biological sciences or analytical chemistry with 5-7 years of industrial or pharmaceutical research experience in bioanalysis. Extensive experience of greater than 10 years in bioanalytical research and biomarker assay development preferred.Used to working in an international environment.To apply, please send your CV and cover letter application to
jobs@aurobac-tx.com
mentioning the reference
ATX24-03 .For more information on how we process your personal data, please visit this linkSector:
Biotech / Health / Antibiotic Resistance, ScienceAUROBAC THERAPEUTICS is proud to be a member of the BEAM Alliance
#J-18808-Ljbffr
As Associate Director Bioanalytical Sciences at AUROBAC, you will be responsible of analytical testing and bioanalysis for preclinical studies and clinical trials conducted in programs of AUROBAC TX portfolio. This includes:- Leading the experimental design, method/assay development and validation, execution and monitoring of bioanalysis of non-clinical and clinical biomarkers, as well as small molecule or biological drug candidate concentrations in biological tissues, whole blood/plasma/ serum/urine with sufficient rigor to meet regulatory compliance and standards- Drafting RFPs and screening CRO/partner capabilities and performance, reviewing and approving vendor SOWs, quotes, establish agreements and bids, establishing credible vendor relationships to support and meet Aurobac program objectives, timelines and milestonesYou will report to the Chief Development Officer (and Chief Medical Officer for clinical work), in close collaboration with AUROBAC TX Research and Clinical Development team.Published on
19 Jul 2024Missions1. Design, Implementation, Monitoring and Control of Developments and Analyses, in Conjunction with Research and Clinical TeamsWork directly with CDO as well as Research and Clinical Development teams to participate in the development of biomarker strategies as well as assay method and validation, and support of transcriptomic/proteomic analyses as well as pharmacokinetic/toxicokineticDefine requirements and specifications for any bioanalytical sciences activity and implement execution– bioanalysis method/assay of non-clinical and clinical biomarkers,– small molecule or biological drug candidate concentrations in biological tissues, whole blood/plasma/serum/urineCoordinate with Research and Clinical Team to ensure sample generation, processing, and storage equipment is available, in satisfactory working condition, and in compliance with assay protocol and laboratory SOPsReview method and protocol development supporting assay validation. Review of formal assay validation documents, laboratory /pharmacy manual and study plan contributions to clinical study protocols and data management interfaceEnsure reliable bioanalytical data transfer of exploratory and/or GLP compliant clinical sample concentrations to team members involved with biomarker development, toxicokinetic, pharmacometrics, and PK/PD analysisMonitor, alert on possible deviations, proposing solutions and implement and follow-up of contingency plans to achieve set objectivesWrite/Review/Validate reports – in compliance with filing and archiving procedures for GLP, GCP and additions to Trial Master File (TMF)2. Management of Bioanalytical Sciences External Partners (CRO, Clinical Laboratories, Other External Stakeholders and Experts) and biobanking PartnersDraft calls for tenders and bidding processes involving CRO/partner selectionReview technical and financial proposals, verify that service providers’ activities are in line with the terms of the contract and specificationsEstablish contract and working relationships with partners and investigators associated with biomarker and drug candidate bioanalysis inclusive of clinical, non-clinical, ex-vivo, and in -vitro samplesPrepare audits of partner laboratories involved with GLP toxicology and clinical study sample bioanalysis and implementation of corrective actions if necessary and follow-up of requested actions until their resolution in collaboration with Quality AssurancePropose and implement solutions for optimal monitoring of the sample bank and participate in the evaluation and arbitration of sample conservation choices for various pre-clinical and clinical projects3. Budget ManagementEvaluate and propose forecast costs to executive team for bioanalytical sciences activitiesMonitor budget, anticipate deviations and necessary alerts to CDO. Propose cost adjustments where applicablePropose, for the duration of the study or trial, ad hoc solutions and/or contingency plans to be implemented in the event of qualitative and quantitative deviationsPersonal skillsFluency in English is a must-have, French language skills would be a major plus.Familiarity and experience with small molecule, biological, and proteomic analysis of biological matrices utilizing LC/MS/MS or related analytical expertise. Additional experience with transcriptomic and immuno-quantitative approaches utilizing RT-PCR, FACS and FITC preferred.Experience and familiarity with regulatory guidance pertaining to validation of bioanalytical assays utilizing Good Laboratory Practices (GLP), Compliance with handling and transfer requirements of human derived tissues and reagents (HIPA, Informed consent and archive storage compliance).Experience with bioanalytical method development process including an understanding of determining linear range of assay, utilization of non-linear regression (as needed), establishing lower and upper limits of quantification, creation of standard curves, use of fortified standards and internal standards for calibration, creation of QC, freeze/thaw stability and dilution integrity standards.Detail-oriented with strong organizational and project management skills. problem-solverStrong in both strategic thinking and day-to-day execution to achieve operational excellence.Professional experienceA Bachelor’s or Master’s degree (PhD preferred) in biological sciences or analytical chemistry with 5-7 years of industrial or pharmaceutical research experience in bioanalysis. Extensive experience of greater than 10 years in bioanalytical research and biomarker assay development preferred.Used to working in an international environment.To apply, please send your CV and cover letter application to
jobs@aurobac-tx.com
mentioning the reference
ATX24-03 .For more information on how we process your personal data, please visit this linkSector:
Biotech / Health / Antibiotic Resistance, ScienceAUROBAC THERAPEUTICS is proud to be a member of the BEAM Alliance
#J-18808-Ljbffr