Yogender Kumar G. Email and Phone Number
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Motivated, focused, and diligent bioprocess engineer with a successful track record of cell culture process development and tech transfer to GMP manufacturing facilities in a highly fast-paced environment. My technical strengths are complemented with empathetic people management skills and excellent communication abilities. Highlights include:• 10+ years of hands-on experience with mammalian cell culture operations with expertise in operations and troubleshooting of bioreactors across multiple scales including micro-scale (ambr15 & ambr250), bench-scale (3L) and pilot-scale bioreactors (Wave bioreactor, 50L & 200L)• Experience working with various product modalities including gene therapy viral vectors, fusion proteins, monoclonal (mAbs) and bi-specifics antibodies• Led multiple projects spanning all phases of biologics life cycle: early phase process development and optimization, scale-up and tech transfer for clinical manufacturing as well as late-stage process characterization studies to identify process CQAs• 6+ years of people management experience with mentoring and developing associates, engineers and scientists at various career levels• Proficient in data analysis and interpretation tools (JMP and Design Expert)• Owner of 2 patents and several paper/poster publications
Asklepios Biopharmaceutical, Inc. (Askbio)
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Principal Scientist, Upstream PdAsklepios Biopharmaceutical, Inc. (Askbio) Oct 2021 - PresentResearch Triangle Park, North Carolina, UsProcess development - Clinicalo Optimized transfection conditions for an existing manufacturing process through multiple DOEs evaluating DNA ratio, total DNA etc. and realized 30% reduction in COGs for clinical campaignso Helped troubleshoot GMP campaigns with low productivity in collaboration with the manufacturing team – identified instrument-to-instrument variability and implemented controls to ensure improved productivity and consistency achieving over 10x increase in vials for clinical useo Led the successful scale-up of next-generation platform process by conducting first 250L large-scale perfusion PD run in single use bioreactorso Assisted in tech transfer of next-generation process to manufacturing partner by undertaking process-in-plant assignment (PiP), reviewing protocols, PDDs and batch-recordsMCB & WCBo Spearheaded the creation of MCB with an external manufacturer to support late-phase clinical program – generated data to support key decisions such as source-vial selection and managed external manufacturer and internal stakeholder interactions. o Created protocols and processes to generate large-scale in-house research cell banks (>200 vials). Evaluated the cell banks for sterility and performance comparability. Technology Developmento Led shake-down studies at the ambr250 scale – established template programs, evaluated perfusion parameters and automated transfection steps o Evaluated new media and feeds for alternate platform process that resulted in over 2x improvements in vector productivity over existing GMP manufacturing processo Collaborated with vendors to evaluate novel technology and platforms such as metabolic flux analysis and low-shear pumps for fluid transfer People Management & Administrationo Managed a team of direct reports to achieve their professional goals and career growth - fostered growth mindset and implemented efficient day-to-day work practiceso Authored high-quality reports and generated presentations -
Manager, Upstream Ms&TKbi Biopharma Dec 2020 - Oct 2021Durham, North Carolina, UsResponsibilities were to lead a team of 5+ engineers to conduct upstream technology transfer of biologics processes from process development into manufacturing, manage internal and external needs, expectations and satisfaction, mentor and guide career development for junior team personnel.Clinical Manufacturing o Oversaw technology transfer, facility fit and successful execution of Phase I clinical programs from PD into manufacturing – navigated challenging supply chain period during the COVID-19 Pandemic by identifying alternate processes and supplierso Supported quality and manufacturing teams on client projects with drafting material specs, owning/assessing change controls, providing impact assessments for deviations, being SME point of contact for investigations and closing out CAPAso Established strategic plans to ensure successful execution of cGMP production operations by collaborating with manufacturing operations, quality, and supply chain. One such example is the creation of BOM for common stock materials People Management & Administrationo Created tech transfer process map, standardized templates, and job-aids to improve procedures, business processes and tools used for upstream tech transfero Revamped and led Upstream MS&T group meetings with structured agenda and objectives to improve cross-team communicationso Performed a wide range of managerial duties pertaining to employees including hiring, on-the-job training, career development, appraising performance, promotion, and disciplinary efforto Managed resources requirements for the projects and team -
Pd Scientist IiKbi Biopharma Dec 2019 - Dec 2020Durham, North Carolina, UsResponsibilities are to lead client biopharmaceutical projects through process development and tech transfer into manufacturing, manage client needs, expectations and satisfaction as well as guide and develop team personnel to handle lab operations, project planning, execution and management within a demanding, fast-paced service environmentProcess development - Clinicalo Led two early-phase process development projects in parallel through clone selection and process optimization studies and scale-up into manufacturing while overcoming significant operational challenges (site-change and contamination) without compromising project timelineso Involved in day-to-day planning and execution of multiple bioreactor studies across scales ranging from shakes flasks, ambr 15 & 250, 3L bioreactors and large-scale single use systems including Wave bioreactor, 50L and 200L SUBso Presented regular project updates to clients and authored detailed reports to assist client products undergoing regulatory approvalTechnology Developmento Implemented SCADA software in collaboration with internal IT team for 3L bench-scale bioreactor system to improve process control in a cost-effective manner o Evaluated and implemented closed shake flask system at pilot-scale facility in order to reduce contamination occurrences and increase pilot plant success rateo Conducted studies to investigate and evaluate new and innovative technologies such as Metabolic Flux Analysis as a means to improve in-house platform upstream processo Contributed to streamlining workflow and gaining efficiency for upstream department via implementation of Electronic Lab Notebook (ELN)People Management & Administrationo As the KBI site lead for AMBIC consortium, attended bi-annual conferences to track project progress and coordinated knowledge transfer through a group of 10 scientistso Managed and guided direct reports to ensure successful completion of deliverables with aggressive timelines -
Upstream Pd Scientist IKbi Biopharma Jul 2016 - Dec 2019Durham, North Carolina, UsResponsibilities are to lead client biopharmaceutical projects through process development and tech transfer into manufacturing, manage client needs, expectations and satisfaction as well as guide and develop team personnel to handle lab operations, project planning, execution and management within a demanding, fast-paced service environmentProcess development - Clinicalo Optimized and developed a scalable GMP manufacturing process for an Eculizumab biosimilar molecule while matching innovator quality attributeso Implemented multiple screening studies to modulate mannose and afucosylation levels of a Humira biosimilar to improve efficacy of the biosimilar and match with the innovatoro Accelerated late-stage process characterization program timeline by 6 months by establishing a representative scale-down model and characterizing the upstream process in a micro-scale high-throughput bioreactor systemo Presented regular project updates to clients and authored detailed reports to assist client products undergoing regulatory approvalTechnology Developmento Contributed to streamlining workflow and gaining efficiency for upstream department via implementation of Electronic Lab Notebook (ELN)o Collaborated with internal cross-functional teams to improve project efficiency. For example, collaborated with analytical team to implement high-throughput sampling strategies to increase efficiency -
Graduate Research AssistantClemson University Aug 2012 - May 2016Clemson, Sc, UsCharacterized the transcriptome of CHO cell lines under industrially relevant conditions using next-generation sequencing technique, RNA-Seq, to understand and address contemporary upstream cell culture challenges• Assessed the impact of temperature and pH on CHO genes involved in recombinant protein production and protein quality, particularly glycosylation • Optimized the serum-free medium adaptation of CHO cell lines and identified the necessary gene expression changes required for successful adaptation• Characterized the impact of initial glucose concentrations on CHO genes related to metabolism and waste production such as lactate• Setup bioinformatics pipelines for next-generation sequencing data analysis in collaboration with Clemson University Genomics Institute (CUGI)• Executed growth studies of recombinant and non-recombinant CHO cell lines (CHO DHFR-, CHO DP-12, CHO-K1, and CHO K1-PF) in T-flasks, shake flasks and bench-scale bioreactors -
Graduate Research AssistantClemson University Aug 2010 - Aug 2012Clemson, Sc, UsInvented a novel two-stage fermentation process for bioethanol production by efficiently utilizing hexose and pentose sugars in hydrolyzed lignocellulosic sources, thereby improving bioethanol yield and productivity• Optimized the two-stage fermentation process to improve ethanol productivity by three-fold in comparison to conventional fermentation methods • Performed side-by-side comparison of yeast species to assess the impact of immobilized xylose isomerase on improving ethanol production• Conducted microbial fermentations in shake flasks and small-scale bioreactors• Facilitated the procurement of the hydrolyzed biomass by coordinating with other research collaborators in order to deliver the project goals -
Intern, Cell Culture Process DevelopmentTakeda Oncology Jun 2015 - Sep 2015Cambridge, Ma, UsInvolved in the identification and selection of a stable second-generation CHO cell line with improved product yields and consistent product quality• Used DOE methods to screen and identify critical factors related to improve/adjust protein galactosylation and antibody acidic-basic charge variant proportion• Assessed the phenotypic stability of candidate sub-clones for cell line selection• Gained hands-on experience in cell thaw, scale-up of cultures, bioreactor setup, operation and troubleshooting, and cell bank creation while adhering to established good lab practices• Complied to good documentation practices during data collection, contributed to technical reports and presented the findings to the management and technical team -
Undergraduate Research AssistantSankara Nethralaya Eye Hospital, Chennai, India Aug 2009 - Apr 2010Isolated and cultured human endothelial cells from umbilical cord and retina that were preserved and later used to closely study angiogenesis and diabetes.Characterized endothelial cells by immunofluorescence technique using factor VIII and DAPI staining procedure.
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Student ResearcherCentral Leather Research Institute Jun 2009 - Jul 2009Carried out bioremediation of leather effluents released from tanning industry using blue-green algae to reduce Cr3+ ions concentration. Also, did a comparative study between live and dead algal cultures for their effectiveness in reducing Cr3+ ion concentration.
Yogender Kumar G. Skills
Yogender Kumar G. Education Details
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Clemson UniversityBioengineering -
Clemson UniversityBioengineering -
Shanmugha Arts, Science, Technology And Research AcademyIndustrial Biotechnology -
P.S.Senior.Seconday.School
Frequently Asked Questions about Yogender Kumar G.
What company does Yogender Kumar G. work for?
Yogender Kumar G. works for Asklepios Biopharmaceutical, Inc. (Askbio)
What is Yogender Kumar G.'s role at the current company?
Yogender Kumar G.'s current role is Leading Process Development Scientist specializing in Biologics-based therapeutics.
What is Yogender Kumar G.'s email address?
Yogender Kumar G.'s email address is yg****@****rma.com
What schools did Yogender Kumar G. attend?
Yogender Kumar G. attended Clemson University, Clemson University, Shanmugha Arts, Science, Technology And Research Academy, P.s.senior.seconday.school.
What are some of Yogender Kumar G.'s interests?
Yogender Kumar G. has interest in Science And Technology, Social Services, Education, Environment.
What skills is Yogender Kumar G. known for?
Yogender Kumar G. has skills like Mammalian Cell Culture, Biofuels, Fermentation, Bioreactor Operation, Upstream Processing, Transcriptomics, Rna Seq, Design Of Experiments, Media Development, Protein Purification, Molecular Biology, Cell Culture.
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