Jansen Luu
Sr. Scientist I at Adverum Biotechnologies, Inc.- Claim this Profile
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Leadership Fundamentals
LinkedInMar, 2021- Nov, 2024
Experience
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Adverum Biotechnologies
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United States
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Biotechnology Research
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1 - 100 Employee
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Sr. Scientist I
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Jan 2022 - Jun 2023
Responsible as SME for supporting cost reductions by upscaling to 1000L upstream production process, commissioning 1000L Single Use Bioreactor, testing components, and ensuring equipment readiness - Implemented bioreactor, ensuring Factory Acceptance Test documentation and testing - Developing staff with training and mentoring in planning, procurement, production - Assessing comparability between sites, around parameter inputs and expected outcomes on upstream production… Show more Responsible as SME for supporting cost reductions by upscaling to 1000L upstream production process, commissioning 1000L Single Use Bioreactor, testing components, and ensuring equipment readiness - Implemented bioreactor, ensuring Factory Acceptance Test documentation and testing - Developing staff with training and mentoring in planning, procurement, production - Assessing comparability between sites, around parameter inputs and expected outcomes on upstream production processes; reviewing compiled internal and CMO data -Built JMP models with process data: better defining input/output variables -Designed efficient scaled down experiments to troubleshoot production challenges -Ensured progress in processing, reduced constraints in sterile filtration clogging and low titer -Generated preliminary data suggesting root cause of 40% reduced titer at clarified lysate step
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TD Scientist II | Team Lead
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Jan 2021 - Jan 2022
I was responsible for efficient implementation of expired consumables for non-GxP production: -Saved $50,000 per production run; expert in use of Adeno-Associated Vector platform -Built MSAT reference library of raw material specifications, equipment manuals, internal executed documents, relevant literature, digitization of data for future trending and analysis -Prevented 6+ month delays when vendors were short on raw materials -Contributed to build of GxP… Show more I was responsible for efficient implementation of expired consumables for non-GxP production: -Saved $50,000 per production run; expert in use of Adeno-Associated Vector platform -Built MSAT reference library of raw material specifications, equipment manuals, internal executed documents, relevant literature, digitization of data for future trending and analysis -Prevented 6+ month delays when vendors were short on raw materials -Contributed to build of GxP manufacturing facility floor plans, process flow diagrams -Proposed solutions clarifying harvest lysate for more robust, efficient processing -Oversaw all upstream pilot plant activities from day to day management of unit operations, ordering of raw materials and consumables, and closing out all documentation associated with processing.
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Manufacturing Specialist
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Aug 2019 - 2021
-Improved tech transfer efficiency by creating database of internal manufacturing processes to external CMO’s detailing processing parameters, recipes, raw materials -Oversaw CMO Fill finish activities via person-in-plant activities. -Monitored Drug Product, Fill Finish activities at CMO processing site to review manufacturing practices, ensuring proper investigation of unexpected events -Harmonized cross functional supply chain documents to create a foundation… Show more -Improved tech transfer efficiency by creating database of internal manufacturing processes to external CMO’s detailing processing parameters, recipes, raw materials -Oversaw CMO Fill finish activities via person-in-plant activities. -Monitored Drug Product, Fill Finish activities at CMO processing site to review manufacturing practices, ensuring proper investigation of unexpected events -Harmonized cross functional supply chain documents to create a foundation for uniformity and consistency across both GxP and non-GxP departments. -Implemented new Tamper Evidence bagging procedures for new international supply chain -Harmonized SOPs and controlled forms across departments for efficiency -Major contributor to hiring, building non GxP internal manufacturing staff -Updated process development protocols to internal manufacturing batch records
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BioMarin Pharmaceutical Inc.
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United States
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Biotechnology Research
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700 & Above Employee
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Clinical manufacturing
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Sep 2016 - Aug 2019
Served as cross-functional SME for large scale operations (fermentation, downstream purification) -Delivered updates to different shifts and upper management -Followed GMP methods to produce drug of interest from seed train to FBDS formulation for a recombinant protein in E.coli -Troubleshooting manufacturing scale equipment such as Bioreactors and TFF’s when there is equipment failure during preparation or processing -Acted as SME for large scale… Show more Served as cross-functional SME for large scale operations (fermentation, downstream purification) -Delivered updates to different shifts and upper management -Followed GMP methods to produce drug of interest from seed train to FBDS formulation for a recombinant protein in E.coli -Troubleshooting manufacturing scale equipment such as Bioreactors and TFF’s when there is equipment failure during preparation or processing -Acted as SME for large scale Operations like Fermentation and Downstream Purification to assist supporting departments such as Facilities, Validation, Manufacturing Sciences, and Process Development -Contributed to commercialization of clinical phase 3 drug -Major input to SOPs, batch records, revisions, improving efficiency and consistency -Secured items for 5S, improving quality of life for manufacturing personnel -Applied large scale process expertise in fermentation, homogenization, continuous feed centrifugation, TFF’s, final formulation -Trained 60% of floor associates on all required processes Show less Served as cross-functional SME for large scale operations (fermentation, downstream purification) -Delivered updates to different shifts and upper management -Followed GMP methods to produce drug of interest from seed train to FBDS formulation for a recombinant protein in E.coli -Troubleshooting manufacturing scale equipment such as Bioreactors and TFF’s when there is equipment failure during preparation or processing -Acted as SME for large scale… Show more Served as cross-functional SME for large scale operations (fermentation, downstream purification) -Delivered updates to different shifts and upper management -Followed GMP methods to produce drug of interest from seed train to FBDS formulation for a recombinant protein in E.coli -Troubleshooting manufacturing scale equipment such as Bioreactors and TFF’s when there is equipment failure during preparation or processing -Acted as SME for large scale Operations like Fermentation and Downstream Purification to assist supporting departments such as Facilities, Validation, Manufacturing Sciences, and Process Development -Contributed to commercialization of clinical phase 3 drug -Major input to SOPs, batch records, revisions, improving efficiency and consistency -Secured items for 5S, improving quality of life for manufacturing personnel -Applied large scale process expertise in fermentation, homogenization, continuous feed centrifugation, TFF’s, final formulation -Trained 60% of floor associates on all required processes Show less
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Research Assistant
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Jun 2015 - Jul 2016
Conducting experiments to determine the mechanistic binding of proteins. Conducting experiments to determine the mechanistic binding of proteins.
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Education
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2012 - 2016
University of California, Santa Cruz
Bachelor’s Degree, Molecular Biology
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