Pete Dixon Email and Phone Number

Responsibilities• Input, development, and deployment of strategy for the robust supply of reference material and critical reagents across the commercial Biopharm supply chain. • Establish and embed new ways of working between GSC, R&D, and external partners to strengthen and improve the commercial Reference Materials and Critical Reagents program to ensure robust supply of high-quality reagents and standards• Identify and maintain critical internal and external partnerships through… Show more Responsibilities• Input, development, and deployment of strategy for the robust supply of reference material and critical reagents across the commercial Biopharm supply chain. • Establish and embed new ways of working between GSC, R&D, and external partners to strengthen and improve the commercial Reference Materials and Critical Reagents program to ensure robust supply of high-quality reagents and standards• Identify and maintain critical internal and external partnerships through management of IQAs, TTS, and SOWs • Establish robust strategy for the annual potency requalification for Biopharm reference materials• Collaborate with respective LOC, Sites and central quality groups to ensure resolution of issues and adherence to quality and compliance standards for reference materials and critical reagents.• Assess changes to reference material and reagent supply and interface with Regulatory when support is required.• Ensure rigorous RCA and effective CAPA development and tracking when issues arise in supply of critical reference materials and reagents.• Response to Regulatory and Agency queries and interactions, LIC and PIRC support, review and update of regulatory dossiers.Accomplishments• Established annual reference material potency requalification strategy which builds upon existing stability program, ensuring robust potency monitoring while minimizing additional consumption of reference material supply• Leveraged internal network to manufacture recombinant rhIL5 critical reagent used in Nucala and Depemokimab potency analyses, resulting in net savings of approximately $1.4 million vs. CMO• Influenced Project teams and Regulatory to enable Annual Reportable strategy for routine reference material crossovers, saving on average 2.5 years over gaining Prior Approvals Show less

Responsibilities• Lead matrix team discussions within MPD and PTRT meetings to drive analytical strategy• Manage resource issues associated with project needs; make strategic analytical decisions and manage partnerships with GSK sites and external suppliers• Lead authoring and review of regulatory submissions authoring and support related RTQs• Delegation of change controls, specification revisions, and authoring of protocols, reports, and regulatory submission… Show more Responsibilities• Lead matrix team discussions within MPD and PTRT meetings to drive analytical strategy• Manage resource issues associated with project needs; make strategic analytical decisions and manage partnerships with GSK sites and external suppliers• Lead authoring and review of regulatory submissions authoring and support related RTQs• Delegation of change controls, specification revisions, and authoring of protocols, reports, and regulatory submission sections• Develop and lead analytical validation and transfer activities at both internal and external organizations worldwide to support late phase biopharmaceutical clinical development through commercialization• Ensure change management is followed for analytical methods and specifications using both CARISMA and M-ERP systems, and ensure alignment with process and method capabilities• Preparation for and support of audits and inspections• Business lead investigator for deviations, investigations, and customer complaints; authoring, implementing, and driving CAPAs to completion• Own and manage method lifecycles, apply appropriate statistical tools to assess assay capability and develop method qualification/validation strategies consistent with ICH requirements and current regulatory opinion.• Coordinate, design, execute and oversee the successful and timely validation and transfer of Biopharm analytical technologies to and from various R&D departments, contract manufacturers, testing labs and GSK commercial manufacturing organizations. Accomplishments• Developed a strong professional affiliation across process and analytical workstreams throughout GSK R&D and PSC• Led the successful transfer of analytical methods to multiple sites worldwide in support of DS and DP manufacture, release, and stability analysis of multiple GSK assets• Supported multiple PAI and other regulatory inspections as Subject Matter Expert Show less

• PMP certified project manager overseeing CMC activities for late stage biopharmaceutical assets into commercialization. • Responsible for leading analytical technology transfers, method development and validation, CQA assessment and specification development, CMO/CRO management, GMP compliance, technical support, change control, regulatory section authoring and F2F audit support for biopharmaceuticals. • Author analytical CMC sections for regulatory submissions and support responses… Show more • PMP certified project manager overseeing CMC activities for late stage biopharmaceutical assets into commercialization. • Responsible for leading analytical technology transfers, method development and validation, CQA assessment and specification development, CMO/CRO management, GMP compliance, technical support, change control, regulatory section authoring and F2F audit support for biopharmaceuticals. • Author analytical CMC sections for regulatory submissions and support responses to agency questions.• Plan and organize strategies to align analytical aspects with manufacturing design and QbD principles.• Contribute to the successful and timely transfer of Biopharm analytical technologies to and from various R&D departments, contract manufacturers, testing laboratories, and commercial manufacturing organizations. Show less

Accomplishments• Developed and validated a total organic carbon-based analytical method to evaluate relative cleanability of different therapeutic protein processes in a multi-product biopharmaceutical pilot facility, resulting in ~$1.5 million in savings through reduction in changeover time and increased batch throughput• Standardized analytical methods, acceptance criteria, and global rationale for changeover of equipment trains between multiple transnational pilot plant… Show more Accomplishments• Developed and validated a total organic carbon-based analytical method to evaluate relative cleanability of different therapeutic protein processes in a multi-product biopharmaceutical pilot facility, resulting in ~$1.5 million in savings through reduction in changeover time and increased batch throughput• Standardized analytical methods, acceptance criteria, and global rationale for changeover of equipment trains between multiple transnational pilot plant organizations• Developed and implemented cleaning validation and verification procedures and analyses, including protein degradation studies and TOC-based swab and solution recovery validations• Subject matter expert on cleaning verification and validation to support clinical and commercial stage manufacturing of biopharmaceutical and vaccine products; provide expert consultation to internal R&D and external global manufacturing customers throughout the world on numerous campaigns. Responsibilities• Lead Biopharm representative on multiple cross-functional teams including site safety, analytical subgroup and global cleaning harmonization teams• Leader of off-hours rapid response team supporting critical equipment used in storage of high-value, business critical materials• Manage concurrent critical path projects, including co-validations and technical transfers to both internal and external organizations• Design and execute research studies in support of equipment train cleaning verification, assay troubleshooting and optimization, and critical reagent stability• Manage analytical equipment lifecycle, including procurement, commissioning and validation, calibration and maintenance, and decommissioning and replacement• Generate cost/benefit analysis and rationale for new technology procurement and repair/replace justification for existing instrumentation and support equipment• Develop, qualify, validate and transfer residual ELISA assay methods to internal and external laboratories Show less

- Analysis of both in-process and development samples in cGMP and research environments- Reverse-phase HPLC quantitation and fingerprint assays of recombinant proteins- In-process residual quantitation by ELISA- Analysis of facility water for TOC and conductivity- Maintenance, calibration, and validation of analytical instruments

Accomplishments- Developed and implemented complete integrated pest management program, including pathogen and insect population monitoring for 18 acre wholesale greenhouse- Investigated the properties of various growth regulating chemicals to determine efficacy on various species of ornamental plants- Performed research in conjunction with Michigan State University to develop a mathematical model to both predict and control bloom stages in various ornamental crops through staged… Show more Accomplishments- Developed and implemented complete integrated pest management program, including pathogen and insect population monitoring for 18 acre wholesale greenhouse- Investigated the properties of various growth regulating chemicals to determine efficacy on various species of ornamental plants- Performed research in conjunction with Michigan State University to develop a mathematical model to both predict and control bloom stages in various ornamental crops through staged manipulation of temperatureResponsibilities- Directly responsible for all phases of production of high-quality wholesale ornamental crops in a five acre greenhouse, including nutritional analysis, customized blending of nutrient solutions, and insect and pathogen diagnosis and control- Performed chemical analyses of growing media, plant tissues and nutrient mixtures- Utilized ELISA testing to diagnose plant pathogens- Other responsibilities included the maintenance and programming of automated environmental and production systems and the supervision of up to 15 employees Show less