Brian Laing, Phd Email & Phone Number

San Diego, California, United States

• Technical responsibility process development and manufacturing.• Subject matter expert (SME) guidance for Oligonucleotide process development and scale-up. • Developing and executing late-stage manufacturing strategy.• Author relevant sections of Regulatory filings, including INDs, IND amendments, and BLAs.• Manage tech transfer activities between CMOs and/or within CMOs for scale-up.• Technical support for Oligonucleotide OOS, OOT, deviations, change controls and nonconformance investigations.• Support process characterization, validation readiness, and PPQ campaign execution.

United States

● Executed technology transfers for process and analytical functions to support manufacturing scale-up and optimization.● Reviewed and approved manufacturing batch records and executed batch records.● Served as key subject matter expert for process development, characterization, and validation activities.● Managed the analytical development function for Vir’s oligonucleotide portfolio.● Authored and reviewed CMC regulatory filings for oligonucleotide products.● Drove the implementation of new processes and analytical technologies to improve quality and yield, reduce the cost of goods, and reduce environmental impact.

San Francisco Bay Area

● Developed overall analytical control strategy for Oligonucleotide Drug Substances and Drug Products.● Served as primary oligonucleotide subject matter expert, providing technical support and knowledge sharing for various CMC functions, including process development, quality control, regulatory affairs, and manufacturing.● Managed external testing and manufacturing activities at CMO/CRO sites, including technology transfers, process development, process optimization, manufacturing campaigns, quality audits, routine testing, and investigations.● Assessed, optimized, and developed analytical test methods for analyzing oligonucleotide therapeutic intermediates, drug substances, and products.● Supported method validation and qualification of test methods.

North Carolina, United States

● Served as overall analytical project manager for multiple clinical stage and commercial Antisense Oligonucleotide (ASO) products supporting internal and external GMP manufacturing campaigns.● Authored and reviewed analytical sections of CMC regulatory filings for ASO and small molecule products.● Trained scientists in executing complex LC-MS methods for QC testing of oligonucleotide starting materials, intermediates, drug substances, and drug products.

Raleigh-Durham, North Carolina Area

● Coordinated method optimizations, method validations, and method transfer for in-country testing of commercial ASO products to support worldwide regulatory filings.● Managed QC testing at CMOs and CLOs, including transfer of methods and OOS investigations.● Identified and implemented new analytical technologies for QC testing small molecules and ASO Products.

Foster City, Ca

● Managed clinical small molecule API projects across multiple sites as analytical lead, providing analytical support and oversight for developing, validating, and transferring analytical methods for GMP Manufacturing campaigns.● Authored GMP test methods and specifications for QC release testing of raw materials, intermediates, and APIs at different phases of clinical development.● Supported structure elucidation for reference material qualification by HRMS and NMR spectroscopy.● Developed methods for detection and low-level quantitation of Potential Genotoxic Impurities (PGIs) in drug substances and intermediates.● Initiated the use of dedicated LC method development tools for rapid screening and optimization using Fusion, Drylab, and Empower on a dedicated LC system

Chapel Hill, Nc

● Synthesized novel lipid and peptide oligonucleotide conjugates for applications in nanomedicine, including various stability-inducing modifications such as: 2’ OMe, 2’ –F, Phosphorothioate, LNA, peptide and fluorescent conjugates.● Analysis, purification, and characterization of molecules by HPLC, NMR, UV-Vis, LC-MS, MALDI-MS, DLS, fluorescence spectroscopy● Authored research manuscripts and review articles ● Served as Co-Chair of the UNC Postdoctoral Association

Chestnut Hill, Ma

● Synthesized modified purine nucleotides for incorporation into Peptide Nucleic Acids (PNA) as potential novel DNA targeting therapeutic agents● Synthesized modified nucleosides and oligonucleotides● Analyzed and characterized molecules by NMR spectroscopy (1H, 13C, 31P, COSY), UV-Vis, LCMS, MALDI-MS, IR, and HPLC analysis.

West Lafayette, In

● Reviewed and verified QC reports from outsourced contract laboratories● Analyzed NMR, IR and MS data for structure elucidation and confirmation ● Performed molecular modeling and structure prediction/verification

West Lafayette, In

● Developed modified nucleic acids to improve therapeutic potential● Improved method for the synthesis and purification of Folate-AMP conjugates for functionalizing RNA nanostructures● Analyzed and characterized molecules by NMR spectroscopy (1H, 13C, 31P, COSY), UV-Vis, LCMS, MALDI-MS, IR, and HPLC analysis.

Rahway, Nj

● Performed preparative chiral chromatography using SFC and HPLC to separate enantiomers● Analyzed, characterized, and developed methods for the purification of process intermediates during the synthesis of pharmaceutical targets in the Process Research Analysis and Preparative Separations (PRAPS) groupAnalyzed, characterized and developed methods for the purification of process intermediates during the synthesis of pharmaceutical targets.

Columbia, South Carolina, United States

● Development of method for quantification of hormone titer levels in insect hemolymph using gas chromatography mass spectrometry (GC-MS). ● Assayed the levels of hormones in Porcine Ovaries to elucidate the role of 17 beta Hydroxysteroid Dehydrogenase/ Ketosteroid Reductase (17HSD/KSR) in steroidogenesis.

Atlanta, Georgia, United States

● Conducted research on triplex DNA formation and stabilization using the DNA intercalating agent coralyne.● Performed UV-Vis melting temperature studies on DNA triple helices and HPLC purification of DNA.

Ph.D., Medicinal Chemistry And Molecular Pharmacology

Activities and Societies: Graduate Student Association

B.S, Chemistry

Activities and Societies: Pre-Health Club - President

Education record

Activities and Societies: Chess Club, School Band, School's Challenge Quiz