I'm in active status as a Award Management (SAM) as a registered US Federal Contractor. Provide professional consulting services to the Biopharmaceutical industry. Focus of consulting is support of either in-house or contracted analytical services supporting development and production biopharmaceutical products. All consulting is focused on cGMP and GLP compliant processes to meet the stringent regulatory needs of clients. I'm currently a contract manager for AccuGenomics (www.accugenomics.com) for implementing Standardized Nucleic Acid Sequencing for Next Generation Sequencing (SNAQ-NGS) in numerous companies. This includes incorporation of this internally standardized NGS method (SNAQ) for detection and quality control supported analysis of infectious viral diseases such as SARS-CoV-2 and Influenza A & B. This technology is also applicable for any biological nucleic acid target (DNA or RNA) for therapeutic or infectious disease indications.

As Senior Director of Quality Control (QC) for Ology Bioservices, Advanced Development & Manufacturing facility (Ology ADM) located in Alachua FL I am responsible for operation of all QC laboratories to include Analytical Chemistry, Cell Assay, Microbiology, BSL-3 and Bioanalytical. I am responsible for quality of all products released under cGMP, GLP and other relevant regulatory criteria. The products manufactured at Ology ADM are principally medical countermeasures (MCM) products against both chemical and biological warfare threat agents. Theses MCMs include various recombinant monoclonal antibodies, recombinant protein therapeutics as well as vaccines. Vaccines include recombinant, viral and bacterial based attenuated vaccines. Manufacture and testing of products produced at Ology Bioservices range from BSL-1, to BSL-3 agents with development, manufacturing and testing performed under the appropriate levels of containment. Testing of recombinant proteins, commonly monoclonal antibodies include complex analysis for release, stability and in-process testing to include UV, FTIR spectroscopy, HPLC, high resolution UPLC for intact and peptide mapping as well as CE, WES, conventional ELISA, ECL-ELISA, SPR by Octet, FACS, cell based bioassays and RT-PCR. All product testing is conducted under cGMP with sample and data management supported by LabVantage LIMS enterprise software. Bioanalytical analysis for ADA and PK analysis of monoclonal antibody products is also performed at Ology under GLP criteria. Environmental monitoring (EM) of the Ology-ADM facility is the responsibility of QC Microbiology group. All EM activities are conducted under relevant cGMP and ISO standards to ensure all controlled areas in development, manufacturing, cell and viral banking suites meet all relevant regulatory standards. All EM activities are managed with the use of MODA enterprise software to ensure schedule compliance and archiving of EM data.

Senior Scientific Advisor for Biotech Services at ABC Labs in Columbia Missouri. Provide relevant advise and specific recommendations for development of our client’s CMC analytical needs using the services of ABC Labs.

DIrector of Biotech Services for ABC Laboratories in Columbia Missouri. This CRO lab services biopharmaceutical and medical device firms providing state of the art biopharmaceutical analytical cGMP services. This is a new laboratory supporting GLP and GMP analytical services for biopharmaceuticals firms. Have a very experienced team to provide a wide array of analytical capabilities ranging from bioassay, immunological tests to include ELISA, wide array of electrophoresis methods and chromatographic methods and protein chemistry to include amino acid analysis and peptide mapping with a wide array of MS capabilities from LC-TOF-MS, LC-ES-MS/MS and IonTrap MS.Analysis of large molecule biopharmaceuticals includes method development and validation, stabiltiy studies, release lot testing, referernce material testing and full analytical characterization. Feel free to contact me for more detailed information. Thanks,John C. Anders, Ph.D.DIrector of Biotech ServicesABC Laboratories4780 DIscovery DrColumbia, MO 65201direct 573 777 6115cell 573 355 7081Personal email anders.john@centurytel.net

Lead development of numerous molecular genomic expression tests for either CLIA or FDA approval as 510K or PMA medical devices. Used a proprietary qPCR methodology called STaRT-PCR or Standardized Reverse Transcription PCR using Standardized Mixtures of Internal Standards (SMIS). THe use of a DNA internal standard which is added to each PCR reaction prior to applification provided a accurate, precise, rugged and reproducible method for absolute quantitation of genomic transcripts. Examples of the genomic expression tests developed at Gene Express Inc under my tenure include LungCentury GX a risk assessment test that measures expression of 10 genes important in protection of the airway from carcinogens in cigarette smoke. If the test indicated poor expression of of this genomic biomarker panel then those patients with a current or past history of smoking are at high risk of developing lung cancer in the future. Armed with such information physicians can monitor such patients more closely with high resolution CT scans to detect early stage lung cancer when it's most treatable. In negotiations with the CDRH division of the USFDA an approved clinical trial protocol and submission route was developed to bring this test to market.Other tests for standardized measurement for BcrAbl in patients afflicted with chronic myelogenous leukemia (CML) and diagnosis of malignant vs. nonmalignant lung cancer as well as small cell vs. non-small cell lung cancer were also under CLIA development.

Served in multiple capacities as senior scientific staff and director of the Biotech laboratory a cGMP CRO laboratory performing analytical services for biopharmaceutical clients. Build a state of the art biopharmaceutical GMP laboratory to provide a wide array of analytical services ranging from cell based bioassay, full chromatographic and protein chemistry methods to include peptide mapping, amino acid analysis and N-terminal sequencing with LC-ES-MS/MS support.

Served in many capacities as an active duty military officer (1st Lieutenant, to Major in the US Army) in very unique scientific organizations within the US Army Medical Research and Development Command. These included Walter Reed Army Institute of Research (WRAIR) and the US Army Medical Institute of Chemical Defense (USAMRICD) at Aberdeen Proving Grounds Maryland. At both organizations was instrumental in the development of various candidate drugs and medical intervention procedures to combat various parasitic diseases as well as ameliorating the toxic affects of chemical warfare (CW) agents. Managed several Investigation of New Drugs (IND) submissions for treatment of malaria and leishmaniasis and participated in a New Drug Application (NDA) for Melfloquine, an antimalarial drug. Also as Chief of Applied Pharmacology at the URAMRICD lead a team for submission of a NDA to the US FDA for pyridostigmine as a chemical prophylaxis against nerve agents. Also lead teams for other medical related chem defense projects.