Experience

PackGene Biotech, Inc.
• United States
• Biotechnology Research
• 1 - 100 Employee
• Senior Scientist

  • Jan 2023 - Present


iBio, Inc.

• United States
• Biotechnology Research
• 1 - 100 Employee

• Principal Scientist

  • Jun 2021 - Present

  Designed processes and parameters for purification of novel therapeutic plant produced proteins for CDMO manufacturing and Phase 1 clinical trials. Supported the development of proteins tailored to internal and external product profiles. Lead projects for process improvements, GMP compliance, pipeline expansion, scale-up process transfer, production platform improvements, culture establishment and improved documentation practices. • Facilitated GMP manufacturing of human proteins for Phase 1 clinical production. Coordinated process transfer and risk assessment. Successfully produced two bulk products for toxicology studies. • Improved regulatory compliance and supported regulatory filings by establishing methodology and documentation around manufacturing batch records, technical reports, process transfer, change management, process parameter establishment and risk assessment. Show less



CSL Behring

• United States
• Biotechnology Research
• 700 & Above Employee

• Pilot Plant Manager: Research and Development Process Development

  • Sep 2017 - May 2021

  Established and managed GMP pilot plants for human and transchromosomal bovine plasma derived proteins. Purified and formulated bulk proteins for Phase I to III clinical studies in a GMP facility. Researched new processes, process improvements, analytical technologies and scale-up/scale-down models. Implemented process improvements on a global scale. Authored procedures and policies for pilot plant operations, cleaning, compliance, data collection, raw materials release, continuous process improvement and safety. Transferred purification methods from laboratory to pilot scale production. Managed nine employees.• Established and updated multiple pilot plant facilities, equipment, documentation, and processes to meet GMP guidelines for a multi-product production.• Managed the process validation for IND/NDA filings, continuous improvement implementation, new products and process monitoring systems.• Managed purification of Phase 1 to III clinical products. Facilitated the transfer, risk assessment and execution of manufacturing processes for an Operation Warp Speed therapeutic. Successfully launched two products for clinical trial. Show less

• Senior Scientist-Research and Development

  • Nov 2011 - Sep 2017

  Researched purification of human plasma proteins for an established and reputable pharmaceutical manufacturing firm. Worked with teams on a global scale to implement new processes, products, presentations, equipment, analytical techniques and manufacturing improvements.• Designed and researched process improvements using ‘quality by design’ and ‘design of experiments’ techniques to improve on the quality attributes of new and existing pharmaceutical products.• Researched new techniques in chromatography, lyophilization, filtration and fractionation to bring new products into the company’s portfolio, improve current manufacturing processes and complete compliance requirements.• Facilitated process and compliance improvements by authoring and executing experiment designs, protocols, reports, risk assessments, stability plans, qualifications and deviations. • Led research projects to bring new presentations of current products to market, fulfill regulatory obligations and meet patient needs.• Worked on scaling up and scaling down industrial manufacturing processes for research, validation and process improvement. Show less



Hematech

• France
• Manufacturing

• Antibody Purification Unit Manager

  • Aug 2004 - Sep 2011

  Managed and maintained GMP laboratory and pilot scale protein purification facilities for a cutting edge biotechnology research company producing novel polyclonal antibodies. Managed and trained three employees. Performed protein purification on transgenic bovine and human plasmas. • Successfully purified novel transgenic polyclonal antibodies in a laboratory and pilot scale class 1000 clean room for process scale-up, antibody subclass and species characterization, in-vitro immunoassay research and pre-clinical in-vivo primate studies. • Designed and conducted research projects for process development involving injectable antibody formulation, stability, safety, scale-up/scale-down, cleaning validation and chromatographic resin binding characteristics. • Researched and qualified analytical immunoassays, HPLC analytical methods, protein purification methods, GE ÄKTA IQ/OQ/PQ, and protein characterizations. • Authored research reports, equipment maintenance protocols, qualification reports, analytical assay monographs, CFR 21 compliance procedures, clean room operation protocols, change controls, out-of-specification investigations and manufacturing procedures. • Presented scientific data to upper management and collaborated on future projects across multiple departments. • Reviewed data and reports used in pre-NDA reports and pre-clinical studies. • Implemented changes in the transformation of a research laboratory into a cGMP compliant manufacturing facility. Show less



Eli Lilly and Company

• United States
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Analytical Chemist

  • Aug 2002 - Jul 2004

  Researched, qualified and validated analytical monographs for active pharmaceutical ingredients and excipients in compliance with regulatory compendia in a GMP quality control laboratory. • Authored and conducted monograph validations, qualifications, harmonizations, source sample audits, product assessments and equipment qualifications. • Completed laboratory deviations and investigations with full root cause analysis. • Performed release testing on raw materials for manufacturing. Show less



Novartis Consumer Health

• Switzerland
• Pharmaceutical Manufacturing

• Quality Control Chemist

  • Oct 1998 - Oct 2001

  Performed analytical assays on small molecule finished pharmaceuticals, active pharmaceutical ingredients and additives following compendial guidelines and validated procedures on small molecule products in a GMP quality control laboratory. • Responsible for batch release, stability testing, process improvement, customer complaint investigation, process development analytical assay, stability assays, raw material testing, tablet dissolution with assays, and cleaning validation testing. • Conducted laboratory deviation investigations, out-of-specification investigations, data collection, peer data review, method transfer, validation, calibration and troubleshooting. Show less



Archer Daniels Midland

• Research Services

• Cereal Chemist

  • Nov 1996 - Oct 1998

  Performed quality testing on cereal grains and final products used in pasta, fermentation, and pre-made baking mixes for protein, moisture, contaminants, lipid content and physical attributes. Authored certificates of analysis and analytical reports. Reported data to upper management and released batches for consumption. Performed quality testing on cereal grains and final products used in pasta, fermentation, and pre-made baking mixes for protein, moisture, contaminants, lipid content and physical attributes. Authored certificates of analysis and analytical reports. Reported data to upper management and released batches for consumption.