Kyle Jones
Manager, BioProcess Technology Group
- Role
- Manager, Bioprocess Technology Group at BDO USA
- Location
- Durham, NC, US
- LinkedIn followers
- 500 followers
About Kyle Jones
Senior analytical scientist with 13+ years of CMC experience working on more than 45 unique molecules (bispecifics, fusion proteins, mAbs, mRNA, biosimilars, enzymes, viral vectors, vaccines). Responsible for maintaining cross-functional relationships, managing deadlines, and interpreting results for therapeutics from discovery to Phase development. Extensive analytical experience utilizing a variety of platforms, such as HPLC, icIEF, Capillary Electrophoresis, Bio-layer Interferometry (BLI), ELISA, Gel Electrophoresis, Western Blot, and qPCR. Ability to multi-task in a fast-passed environment with overlapping timelines.
Experience
Manager, Bioprocess Technology Group
Nov 2024 — Present
CMC analytical consultant for method development, transfer, validation, characterization, and quality control release/stability analysis.Manage and support large molecule, cell-based, and gene therapeutics in pre-clinical development through BLA/MAA filing.Utilize JMP software to analyze data for method transfer and validation studies. Perform trend analysis for stability studies. Prepare analytical CMC sections for IND/IMPD filings and perform gap and risk assessments in preparation for BLA/MAA filings. Develop a phase appropriate strategy for therapeutics to prioritize activities while addressing regulatory requirements. Provide support in CMO/CRO selection and auditing.
Education
North Carolina State University
Bachelor of Science - BS, Microbiology, General
2008 — 2012
North Carolina State University
Master's of Microbial biotechnology
2012 — 2014
Skills
- Pcr
- Sds-Page
- Product Development
- Spectroscopy
- Hplc
- Life Sciences
- Uplc
- Powerpoint
- Microsoft Excel
- Experimental Design
- Animal Welfare
- Bacterial Culture
- Microsoft Word
- Adsorption
- Data Analysis
- Western Blotting
- Laboratory
- Capillary Electrophoresis
- Leadership
- Method Transfer
- Aseptic Technique
- R&D
- Gel Electrophoresis
- Method Development
- Tlc
- Biotechnology
- Protein Purification
- Research and Development (R&D)
- Downstream Processing
- Statistics
- Bca Protein Assay
- Cell Culture
- Teamwork
- Molecular Biology
- Lifesciences
- Elisa
- Microbiology
- Microscopy
- Market Research
- Recombinant Dna Technology
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