Develop analytical methods for elucidating the mechanisms involved in phosphate solubilization by microorganisms.

Authored technical documents, including QC test methods, validation protocols, validation reports, SOPs, work instructions, and justification of specifications used to support numerous marketed products. Extracted, compiled, and interpreted data from a variety of sources, including SAP, EDMS, Empower, and paper documents, to answer questions and provide required justifications identified during authoring and revising technical documentation. Wrote detailed instructions for use of both… Show more Authored technical documents, including QC test methods, validation protocols, validation reports, SOPs, work instructions, and justification of specifications used to support numerous marketed products. Extracted, compiled, and interpreted data from a variety of sources, including SAP, EDMS, Empower, and paper documents, to answer questions and provide required justifications identified during authoring and revising technical documentation. Wrote detailed instructions for use of both laboratory instruments and software applications. Used Six Sigma techniques to define and optimize system and business processes to minimize bottlenecks and ensure peak efficiency was maintained with a reduced workforce. Show less

Revised technical documents, including QC test methods, validation protocols, validation reports, SOPs, and work instructions used to support numerous products marketed by Upsher-Smith Laboratories, Inc.

Authored test scripts for validation of 6 custom Crystal Reports for use on a Global Laboratory Information Management System (LIMS) utilized by 4 global R&D and manufacturing sites.

Managed all accounting and financial activities for business with over $1 million in annual sales. Negotiated multi-year sales contract valued at more than $400,000. Worked with state and federal agencies to ensure full regulatory compliance.

Quality Specialist (4/'04 – 4/'07)Led global LIMS project to implement a centralized LIMS across 5 R&D and manufacturing sites. Created a unified data model for the global LIMS by consolidating best practices from each site. Developed novel prioritization system for entry of critical manufacturing information. Utilized Six Sigma techniques to reduce overall cycle time, and personnel time. Wrote user guides and technical manuals for use with the LIMS to ensure standardized… Show more Quality Specialist (4/'04 – 4/'07)Led global LIMS project to implement a centralized LIMS across 5 R&D and manufacturing sites. Created a unified data model for the global LIMS by consolidating best practices from each site. Developed novel prioritization system for entry of critical manufacturing information. Utilized Six Sigma techniques to reduce overall cycle time, and personnel time. Wrote user guides and technical manuals for use with the LIMS to ensure standardized practices.Research Specialist/Senior Analytical Chemist (10/'96 – 3/'04)Led cross-functional technical team during the successful implementation, validation, and use of LIMS by the 3M Pharmaceuticals and Drug Delivery Systems R&D laboratories in St. Paul. Established guidelines and SOPs to ensure adherence to all regulatory requirements and cGMPs related to the pharmaceutical stability program.Senior Analytical Chemist (3/'87 - 10/'96)Led technical team during the generation, compilation, and analysis of analytical test results used for the NDA submission for a new inhalation product. Planned and performed all analytical testing required to successfully qualify a new manufacturing site as an approved raw drug substance supplier for a marketed product. Established agreements with global contract testing laboratories to provide supplemental analytical testing capabilities. Negotiated substantial discounts on fee schedules.Advanced Analytical Chemist (11/'84 - 3/'87)Provided comprehensive analytical support for 3 proprietary new chemical entities (NCEs), from early synthesis through pilot plant scale-up, by developing and validating stability indicating assays. Coordinated work on synthesis and proof of structure for reference standards of the drug substances, impurities, and degradation products. Performed the extensive preformulation testing and stress stability studies used in IND submissions.Analytical Chemist (1/'84 - 11/'84)Improved and validated analytical test methods. Show less

Developed analytical methods for characterization and purification of proteins and peptides produced through molecular biology or by peptide synthesis. Developed techniques for conjugating peptides to large molecular weight protein adjuvants.

Developed techniques for extraction, isolation, chemical cleavage, and analysis of viral membrane glycoproteins. Determined immunological properties of the isolated peptides.

Developed a series of in vitro tissue culture systems to evaluate the effectiveness of x-irradiation in conjunction with potential chemotherapeutic agents and hyperthermia treatments.