Experience

Dermavant Sciences

• United States
• Biotechnology Research
• 200 - 300 Employee

• Associate Director, Bioanalysis

  • Jul 2018 - Present

  Coordination of bioanalytical activities to ensure timely support and relevant regulatory guidance to both nonclinical and clinical programs. Identify and qualify CRO’s, and obtain cost estimates for bioanalytical project requirements. Set up MSA’s, contracts/work orders providing bioanalytical support of clinical and nonclinical studies. Review assay development, and validation data to ensure methods provide adequate accuracy, precision, reproducibility, and compliance with… Show more Coordination of bioanalytical activities to ensure timely support and relevant regulatory guidance to both nonclinical and clinical programs. Identify and qualify CRO’s, and obtain cost estimates for bioanalytical project requirements. Set up MSA’s, contracts/work orders providing bioanalytical support of clinical and nonclinical studies. Review assay development, and validation data to ensure methods provide adequate accuracy, precision, reproducibility, and compliance with regulatory requirements. Review sample analysis reports and data, communicate results to the project teams, and work with vendors to troubleshoot any issues in the completion or executions of project deliverables. Contribute to the authoring of regulatory submissions including IBs, INDs, and NDA submission modules Show less Coordination of bioanalytical activities to ensure timely support and relevant regulatory guidance to both nonclinical and clinical programs. Identify and qualify CRO’s, and obtain cost estimates for bioanalytical project requirements. Set up MSA’s, contracts/work orders providing bioanalytical support of clinical and nonclinical studies. Review assay development, and validation data to ensure methods provide adequate accuracy, precision, reproducibility, and compliance with… Show more Coordination of bioanalytical activities to ensure timely support and relevant regulatory guidance to both nonclinical and clinical programs. Identify and qualify CRO’s, and obtain cost estimates for bioanalytical project requirements. Set up MSA’s, contracts/work orders providing bioanalytical support of clinical and nonclinical studies. Review assay development, and validation data to ensure methods provide adequate accuracy, precision, reproducibility, and compliance with regulatory requirements. Review sample analysis reports and data, communicate results to the project teams, and work with vendors to troubleshoot any issues in the completion or executions of project deliverables. Contribute to the authoring of regulatory submissions including IBs, INDs, and NDA submission modules Show less



Roivant Sciences

• United States
• Biotechnology
• 100 - 200 Employee

• Associate Director, Bioanalysis

  • Nov 2017 - Jun 2018

  Leader of the bioanalytical team with responsibility for CRO relationship governance and coordination of bioanalytical support across all projects in the portfolio to ensure timely bioanalytical support and relevant regulatory guidance to both nonclinical and clinical programs. Identify and qualify CRO’s, and obtain cost estimates for bioanalytical project requirements. Set up MSA’s, contracts/work orders providing bioanalytical support of clinical and nonclinical studies… Show more Leader of the bioanalytical team with responsibility for CRO relationship governance and coordination of bioanalytical support across all projects in the portfolio to ensure timely bioanalytical support and relevant regulatory guidance to both nonclinical and clinical programs. Identify and qualify CRO’s, and obtain cost estimates for bioanalytical project requirements. Set up MSA’s, contracts/work orders providing bioanalytical support of clinical and nonclinical studies. Review assay development, validation, and stability data to ensure method provides adequate accuracy, precision, reproducibility and compliance with regulatory requirements.

• Manager, Bioanalytical Services

  • Jan 2017 - Oct 2017

  Coordinate bioanalytical assay support across all projects in the portfolio to ensure timely bioanalytical support and relevant regulatory guidance to both nonclinical and clinical programs. Identify and qualify CRO’s, and obtain cost estimates for bioanalytical project requirements. Set up MSA’s, contracts/work orders providing bioanalytical support of clinical and nonclinical studies. Review assay development, validation, and stability data to ensure method provides adequate… Show more Coordinate bioanalytical assay support across all projects in the portfolio to ensure timely bioanalytical support and relevant regulatory guidance to both nonclinical and clinical programs. Identify and qualify CRO’s, and obtain cost estimates for bioanalytical project requirements. Set up MSA’s, contracts/work orders providing bioanalytical support of clinical and nonclinical studies. Review assay development, validation, and stability data to ensure method provides adequate accuracy, precision, reproducibility and compliance with regulatory requirements.



Covance

• United States
• Research Services
• 700 & Above Employee

• Lead Scientist

  • Oct 2016 - Jan 2017

  Lead and direct scientific work to support method development, validation, and sample analysis studies for assigned client programs. Give scientific directions to team members and ensure regulatory guidelines and expectations are met. Communicate and monitor scientific expectations with scientific staff and clients. Lead study and assay troubleshooting activities to ensure that client expectations of scientific rigor and timelines are met. Lead and direct scientific work to support method development, validation, and sample analysis studies for assigned client programs. Give scientific directions to team members and ensure regulatory guidelines and expectations are met. Communicate and monitor scientific expectations with scientific staff and clients. Lead study and assay troubleshooting activities to ensure that client expectations of scientific rigor and timelines are met.



Tandem Labs/Covance

• Project Manager

  • Mar 2015 - Sep 2016

  Act as the primary point of contact for clients and communicate with them on project statuses, and deliver to them study results and reports. Schedule and monitor resources for the timely completion of sponsor studies with the responsibility of ensuring the study conduct is adhering to GLP and all relevant regulations. Perform method development and oversee validation of methods. Maintain accurate revenue projections, and invoice for analytical work… Show more Act as the primary point of contact for clients and communicate with them on project statuses, and deliver to them study results and reports. Schedule and monitor resources for the timely completion of sponsor studies with the responsibility of ensuring the study conduct is adhering to GLP and all relevant regulations. Perform method development and oversee validation of methods. Maintain accurate revenue projections, and invoice for analytical work conducted. Provide technical guidance to junior chemists. Show less Act as the primary point of contact for clients and communicate with them on project statuses, and deliver to them study results and reports. Schedule and monitor resources for the timely completion of sponsor studies with the responsibility of ensuring the study conduct is adhering to GLP and all relevant regulations. Perform method development and oversee validation of methods. Maintain accurate revenue projections, and invoice for analytical work… Show more Act as the primary point of contact for clients and communicate with them on project statuses, and deliver to them study results and reports. Schedule and monitor resources for the timely completion of sponsor studies with the responsibility of ensuring the study conduct is adhering to GLP and all relevant regulations. Perform method development and oversee validation of methods. Maintain accurate revenue projections, and invoice for analytical work conducted. Provide technical guidance to junior chemists. Show less



GSK

• United Kingdom
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Bioanalytical Extrernal Study Monitor

  • Aug 2013 - Mar 2015

  Responsible for the oversight of method development, transfer, and validation of bioanalytical and dose formulation assays, and the application of these assays to preclinical and clinical studies at CROs. Collaborated in a complex matrix team environment with contracting group, DMPK and relevant disciplines internally and at CROs to manage and resolve scientific, technical or compliance issues to ensure study quality and to define best practices for bioanalytical outsourcing… Show more Responsible for the oversight of method development, transfer, and validation of bioanalytical and dose formulation assays, and the application of these assays to preclinical and clinical studies at CROs. Collaborated in a complex matrix team environment with contracting group, DMPK and relevant disciplines internally and at CROs to manage and resolve scientific, technical or compliance issues to ensure study quality and to define best practices for bioanalytical outsourcing. Planned, facilitated, and lead CRO site audits to appraise scientific quality and technical capability. Drafted responses to bioanalytical queries from Regulatory Authorities (FDA, EMA, ANVISA, Health Canada, Turkey, Israel) and several bioanalytical regulatory submission modules. Concurrently managed between 60-70 studies on average covering all phases of preclinical and clinical bioanalysis.

• Investigator/Team Leader

  • Dec 2010 - Jul 2013

  Managed a team of 2-3 scientists and served as a mentor for two additional employees during fixed term cross departmental transfer program with responsibilities for all training, goal setting, and management of these employees. Acted as responsible scientist or principal investigator for the bioanalytical and toxicokinetic portions of preclinical toxicology studies. Analyzed concentration data using WinNonLin, interpreted data, and reported tk results and conclusions. Oversaw… Show more Managed a team of 2-3 scientists and served as a mentor for two additional employees during fixed term cross departmental transfer program with responsibilities for all training, goal setting, and management of these employees. Acted as responsible scientist or principal investigator for the bioanalytical and toxicokinetic portions of preclinical toxicology studies. Analyzed concentration data using WinNonLin, interpreted data, and reported tk results and conclusions. Oversaw CRO assay validations, contracted clinical sample analysis studies, conducted teleconferences, communicated timelines and expectations to CRO’s and internal customers, and provided technical expertise and guidance to the CRO’s. Evaluated the critical bioanalytical SOPs for several Indian CRO’s to determine their regulatory compliance prior to several planned bioequivalence studies and served as DMPK expert for the clinical teams.

• Associate Scientist/Scientist/Senior Scientist

  • Nov 2004 - Dec 2010

  Performed sample analysis, method validations, and development of methods in biological samples using HPLC/MS/MS instrumentation. (Sciex API-3000/4000/5000 ,Waters Acquity and LEAP autosamplers) Responsible for analytical method and validation report writing, communicating with internal and external customers regarding project progress, sample preparation, data analysis, troubleshooting methods and instrumentation, training new analysts, and performing experiments and documentation in… Show more Performed sample analysis, method validations, and development of methods in biological samples using HPLC/MS/MS instrumentation. (Sciex API-3000/4000/5000 ,Waters Acquity and LEAP autosamplers) Responsible for analytical method and validation report writing, communicating with internal and external customers regarding project progress, sample preparation, data analysis, troubleshooting methods and instrumentation, training new analysts, and performing experiments and documentation in accordance with GLP regulations. Analyzed dose formulations for GLP studies and validated methods for these analyses using HPLC-UV instrumentation and TotalChrom software.



Cardinal Health, SPS

• Biochemist I

  • Dec 2002 - Nov 2004

  Assisted with method development, performed GLP method validations, and sample analysis projects for external clients using LC/MS instrumentation for the determination of small molecules in various biological matrices. Utilized Cohesive HTLC extraction system coupled with Sciex API-3000 Mass Spectrometers. Also performed solid phase extractions, ELISA experiments, and used protein precipitation sample preparation techniques.

• Sample Coordinator

  • Sep 2001 - Dec 2002

  Received sample shipments from clients, shipped biological and chemical samples, entered sample data in sample tracking databases for entire Bioanalytical division, and shared same responsibilities for analytical groups. GLP documentation of sample receipt, custody, and final disposition. Responsible for documentation of sample storage protocols, and correspondence regarding sample shipments with sponsoring pharmaceutical companies. Assisted with sample and mobile phase prep within… Show more Received sample shipments from clients, shipped biological and chemical samples, entered sample data in sample tracking databases for entire Bioanalytical division, and shared same responsibilities for analytical groups. GLP documentation of sample receipt, custody, and final disposition. Responsible for documentation of sample storage protocols, and correspondence regarding sample shipments with sponsoring pharmaceutical companies. Assisted with sample and mobile phase prep within Bioanalytical division.