The Biopharm Manufacturing Site In Rockville MD Currently Has An Opening For a Director BPT. Drug Substance (DS) Biopharmaceutical Technology And NPI Will
• Lead the Biopharmaceutical Technology Department for GMS Biopharm, focusing on delivering new biopharmaceutical products, applications and technologies as well as on delivering improvements to the existing supply chains supported by GMS Biopharm and technology transfers between GMS Biopharm & R&D. Direct the transfer of DS biopharmaceutical production processes and technologies from R&D, third party clients, or Contract Manufacturing Organisations to GMS Biopharm and from GMS Biopharm to other biopharmaceutical manufacturing sites.
• Provide product technical lifecycle management with regards to process improvement, process knowledge management, batch deviations, and ensuring accuracy of regulatory CMC registered detail. As part of lifecycle management, this department has direct responsibilities for continuously reducing product COGS while improving product quality for products supplied by GMS Biopharm. Lead the process informatics (data management & analysis) service shared service to support Biopharmaceutical manufacturing activities within GMS.
• Develop and execute business development strategies to maximize profitable use of GMS Biopharm manufacturing capacity through external business development / marketing efforts and / or mutually beneficial Supply Agreement’s within GSK. Support the New/Commercialized Product teams and the supply chain in all manufacturing aspects
Ii) Drug Substance Biopharmaceutical Process Development For CMO Programs And Internal GMS Transfers
• For all Biopharm GMS 3rd party CMO Business (Rockville and Upper Merion GMS sites), serve as technical lead for all biopharmaceutical bevelopment activities, with no involvement from CoE or R&D. This includes developing the overall process development and process validation strategies in partnership with the 3rd party client, as well as process development, process characterization, small scale validation, viral clearance studies, and scale-up activities for both clinical and commercial GMP production.
• For GMS products facility transfers, lead laboratory process scale up/scale activities to facilitate late stage/commercial product transfers between GMS facilities including executing any supporting process development, process characterization, small scale validation, viral clearnance work, authoring the process development technical documentation NPI ‘sender’ package and subsequent regulatory documentation authoring.
• For R&D Biopharm Advanced Manufacturing Technology (AMT) program, evaluate new step changing technology platforms for GSK in partnership with R&D. Lead development of study plans, execute laboratory work and analysis to evaluate and industrialize these technologies.
General:Manage a portfolio of projects and take ownership of complex / major / multiple projects by taking accountability for the progress of project against agreed timelines, budget and quality, liaising with all levels of management and customers as appropriate. As a member of the site leadership team, support all site initiatives to ensure site metrics are met.
• Tech Transfer: Responsible for the introduction of new DS processes into the site as tech transfer ‘receiver’, and supporting any transfers from the site to other facilities as tech transfer ‘sender’.
• Oversee the product technical lifecycle management for GMS assets through champion business cases for manufacturing technology implementation or other strategic projects.
• Be accountable for Process Informatics and provide data management and analysis leadership/support for biopharmaceutical related activities to facilitate Continued Process Verificiation (CPV).
• Process Control Strategy / QbD/ PPQ: Directly influence the GSK QbD (Quality by Design)/DFM (Design for Manufacture) strategy being developed by Biopharm R&D for Biopharmaceutical products and champion the implementation of relevant aspects of QbD within GMS Biopharm. In collaboration with R&D BPD and CoE for GSK products, establish process control strategies and specification windows for manufacturing during commercialization at scale and assures that batches are representative of process capabilities. For late stage/ commercial products, responsible for large scale Process Performance Qualification (PPQ). For GSK products this is in partnership with CoE and R&D. Author relevant large scale manufacturing CMC sections for regulatory documentation.
•CMO Biopharmaceutical Process Development: Sole technical lead (i.e., no involvement from CoE or R&D) responsible for all Biopharmaceutical Development activities including the overall process development and validation strategies in partnership with the 3rd party client, as well as Process Development, Process Characterization, Small Scale Validation, Viral Clearance studies and scale-up activities for both clinical and commercial GMP production. Serve as Process Development representative on joint steering committees with CMO clients.
•Internal GMS transfers Biopharmaceutical Process Development: For GMS facility transfers, lead laboratory process scale up/ scale activities to facilitate late stage/commercial product transfers between GMS facilities including executing any supporting process development, process characterization, small scale validation, viral clearnance work, authoring the process development technical documentation NPI ‘sender’ package and subsequent regulatory documentation authoring.
• CMO & GSK products laboratory campaign support: Execute both bench scale and pilot scale laboratory studies to support manufacturing campaign investigations, process robustness studies to enhance process understanding, raw material variability evaluation and raw material expiry extensions. This may include supporting GSK products manufacturing at external 2rd party sites.
• R&D Biopharm New Technologies: Evaluate new step changing technology platforms for GSK in partnership with the R&D Advanced Manufacturing Technologies program by development of study plans, execution of laboratory work and analysis to evaluate and industrialize these technologies. Basic qualifications:
Masters in appropriate scientific or technical discipline.
At least 10 years industrial experience in technology/biopharmaceutical process development, technical project management and process transfer to production in a biopharmaceutical/biotechnology manufacturing environment.
Prior experience leading groups in a biopharmaceutical/biotechnology manufacturing environment involved with technology development and process transfer expected to exceed 5 years.
Prior experience with biopharmaceutical product registration preferably with FDA and/or EMEA.
Knowledge of current GMP's, ICH Guidelines and FDA/EU validation practices for biopharmaceutical processes required.
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