Daniel Martin Email & Phone Number

Raleigh, Nc, Us

-Support day to day manufacturing operations within Vir's network of CDMOs for early and late-stage clinical manufacturing, manufacturing start up, change management, deviation management and batch record review to support lot disposition -Serve as manufacturing CMC representative to drive strategic decision making -Support CMC regulatory affairs for IND amendment authoring (Module 3.2s and 3.2p) using Veeva RIMs-Provide regulatory agency RTQ responses when… Show more -Support day to day manufacturing operations within Vir's network of CDMOs for early and late-stage clinical manufacturing, manufacturing start up, change management, deviation management and batch record review to support lot disposition -Serve as manufacturing CMC representative to drive strategic decision making -Support CMC regulatory affairs for IND amendment authoring (Module 3.2s and 3.2p) using Veeva RIMs-Provide regulatory agency RTQ responses when applicable-Collaborate with Clinical Development teams to drive dug product supply that enables clinical trial strategy -Lead cross-functional teams in a matrix environment and drive internal/external communications to execute external manufacturing operations -Serve as CDMO relationship manager across the contract manufacturing lifecycle decide, select, transfer, manage, exit -Work with the external manufacturing and transactional law teams to establish development and supply contracts and statements of work (SOW) -Prepare purchase requests for procurement of materials and services through Vir's standard tools Invoice management and revenue recognition with our vendors using Coupa, Agiloft, and NetSuite-Onboard new vendors in Vir quality management system and manages change notifications for existing Vir vendors -Developed and tracked KPIs to monitor CDMO operational performance and compliance status -Manage GxP document control, storage, archival, retention, access and handling for CDMO cGMP manufacturing operations Show less

Remote

Durham, North Carolina, United States

-Led CMC development for robust, scalable purification processes for AAV gene therapy vectors of different varieties for early-stage orphan drugs -Utilized training in situational leadership to direct early-stage Process Development activities -Developed and maintain budget for Process Development group -Designed and lead execution of small-scale unit operation optimization and robustness studies using DOE methodology -Wrote, review and present technical… Show more -Led CMC development for robust, scalable purification processes for AAV gene therapy vectors of different varieties for early-stage orphan drugs -Utilized training in situational leadership to direct early-stage Process Development activities -Developed and maintain budget for Process Development group -Designed and lead execution of small-scale unit operation optimization and robustness studies using DOE methodology -Wrote, review and present technical documentation including module 3s regulatory IND filings -Led downstream technology transfer activities to large scale AAV manufacturing (200 L BRX) -Contributed to strategic cross functional planning to support development across multiple functional areas for early phase AAV drug development Show less

-Represented the technical operations department before clients, regulatory agencies, and management Served as TFF SME for a COVID-19 vaccine under Operation Warp Speed -Led a small team of Associate Process Engineers to perform historical batch analysis to derive KPIs for future manufacturing batches -Implemented technology transfer of multiple projects at various project life-cycle stages Pre-IND and up to BLA -Executed process risk review, process qualification… Show more -Represented the technical operations department before clients, regulatory agencies, and management Served as TFF SME for a COVID-19 vaccine under Operation Warp Speed -Led a small team of Associate Process Engineers to perform historical batch analysis to derive KPIs for future manufacturing batches -Implemented technology transfer of multiple projects at various project life-cycle stages Pre-IND and up to BLA -Executed process risk review, process qualification, and validation activities -Applied basic project management to ensure objectives are achieved -Developed training and implementation of manufacturing staff during scale up activities, preprocess qualification, process qualification, and validation -Interacted with stakeholders to report technical results of process development activities, project deliverables, and process readiness -Served as technical liaison during regulatory agency pre-approval inspection (PAI) activities and defense Show less

-Assisted in the evaluation, development, and implementation of new downstream technologies leading to process improvements and efficiency of operation -Responsible for coordinating and operating pilot plant unit operations and planning demonstration runs following bench scale establishment runs -Led forward processing purification of differing molecules by chromatography, viral filtration, ultra-filtration, diafiltration, and bulk filling -Assisted in tech transfer from… Show more -Assisted in the evaluation, development, and implementation of new downstream technologies leading to process improvements and efficiency of operation -Responsible for coordinating and operating pilot plant unit operations and planning demonstration runs following bench scale establishment runs -Led forward processing purification of differing molecules by chromatography, viral filtration, ultra-filtration, diafiltration, and bulk filling -Assisted in tech transfer from bench scale development to 50-200 L pilot scale and managed bill of materials to support pilot plant operations -Executed scale down mock qualification runs to support viral clearance studies -Executed viral clearance studies at BioReliance to support phase III activities -Executed phase III process characterization studies-Served as chromatography method Unicorn v6 & v7 SME for PD to support tech transfer to 2k manufacturing Show less

Rtp, Nc

-Demonstrated adequate knowledge to lead or coordinate key downstream cGMP process steps: Affinity chromatography, Viral inactivation, Intermediate and polishing chromatography, Viral filtration, Ultrafiltration and diafiltration, and bulk drug substance fill -Experience in executing validation protocols to support the validation master plan (VMP) -Led documentation and LIMS management of cGMP bulk fill operations in large-scale purification -Recognized process or… Show more -Demonstrated adequate knowledge to lead or coordinate key downstream cGMP process steps: Affinity chromatography, Viral inactivation, Intermediate and polishing chromatography, Viral filtration, Ultrafiltration and diafiltration, and bulk drug substance fill -Experience in executing validation protocols to support the validation master plan (VMP) -Led documentation and LIMS management of cGMP bulk fill operations in large-scale purification -Recognized process or equipment issues and demonstrates knowledge of appropriate mitigation -Performed GMP IPC sample analysis and collected data via pH, conductivity, UV spectrophotometry, and SoloVP concentration measurements -Actively collected and inputted data from executed batch records into electronic data management systems for use in manufacturing support departments -Served as chromatography packing SME to support large scale (1 meter diameter) chromatography packing activities in the large-scale manufacturing suites-Obtained certificate of Safety and Chemical Engineering Education (SACHE). Show less

United States

-Developed and built a lab scale qualification skid for intermediate size columns in order to study and improve column packing challenges at a pilot scale -Implementation allowed for packing and qualification of BPG200, BPG300, and BPG450 GE columns in the manufacturing sciences bench scale lab -Collaborated with Carolina Mechanical Services to design a resin height gauge to be implemented in large scale manufacturing of Resin height gauge was validated and is now used in GMP… Show more -Developed and built a lab scale qualification skid for intermediate size columns in order to study and improve column packing challenges at a pilot scale -Implementation allowed for packing and qualification of BPG200, BPG300, and BPG450 GE columns in the manufacturing sciences bench scale lab -Collaborated with Carolina Mechanical Services to design a resin height gauge to be implemented in large scale manufacturing of Resin height gauge was validated and is now used in GMP manufacturing during large scale column packing -Utilized FBRM technology to evaluate chromatography resin integrity Show less

Rtp, Nc

-Developed skills and knowledge pertaining to Focused Beam Reflectance Measurements (FBRM) using a ParticleTrack G600 by Mettler Toledo -Collaborated with scientists, engineers, manufacturing operators, and Mettler Toledo to train and understand the potential use in different unit operations for FBRM -Implemented Process Analytical Technology (PAT) using FBRM on clinical production runs in harvest operations -Utilized FBRM to participate in an investigation to evaluate… Show more -Developed skills and knowledge pertaining to Focused Beam Reflectance Measurements (FBRM) using a ParticleTrack G600 by Mettler Toledo -Collaborated with scientists, engineers, manufacturing operators, and Mettler Toledo to train and understand the potential use in different unit operations for FBRM -Implemented Process Analytical Technology (PAT) using FBRM on clinical production runs in harvest operations -Utilized FBRM to participate in an investigation to evaluate filter performance in harvest operations and authored the failure investigation report to determine compliance -Developed pilot scale experiment using FBRM to characterize centrifugation efficiency during harvest operations o Generated data for different centrifugation operating setups, including a recycle stream, to characterize clarification Show less

Rtp, Nc

-Developed and led a project to characterize chromatography packing characteristics through a variety of bench scale experiments -Characterized resin matrix shrinking and expansion in different buffer and temperature conditions-Implemented vibration methods to disrupt wall effects observed during chromatography column packing-Wrote Unicorn methods for pressure testing chromatography packed bed integrity -Continued development of a historical database of column… Show more -Developed and led a project to characterize chromatography packing characteristics through a variety of bench scale experiments -Characterized resin matrix shrinking and expansion in different buffer and temperature conditions-Implemented vibration methods to disrupt wall effects observed during chromatography column packing-Wrote Unicorn methods for pressure testing chromatography packed bed integrity -Continued development of a historical database of column packing process parameters and success Show less

Raleigh, Nc

• Involved in standardized care for dogs and cats.• Assisting Doctors by administering medication, distributing medication, obtaining blood samples, and organizing administrative paper work.• Interfacing with clients concerning their animal’s health.

Asheboro, Nc

• Assisted in developing and running a microbial diagnostics laboratory.• Collaborated with large animal veterinarian and farm manager.• Obtained artificial insemination certification.• Implemented artificial insemination skills to breed dairy cows.

Master Of Science - Ms, Regulatory Affairs

Bachelor Of Science (Bs), Chemical Engineering Concentrating In Biomanufacturing

Activities and Societies: Member of NCSU Skateboarding Club - Officer 2011-1013 Member of Wolfpack Motorcycle Association I studied.