Aquatic Toxicologist/environmental Toxicologist/research Toxicologist
Managed all laboratory and field aquatic toxicology investigations for Agricultural Chemicals and various Industrial Chemicals Divisions
- As study director, managed all technical and regulatory aspects of $5 MM aquatic mesocosm project conducted in three geographic locations. Interfaced with EPA on protocol and reporting details. Presented results at professional meeting. Received departmental commendation.
- Coordinated team in preparing a dossier for regulatory submission from more than 100 toxicology, product chemistry and environmental fate studies.
- Received Incentive Award for work supporting the Process Additives Division
- Coauthored three publications on pharmaceutical excipients toxicology.
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Associate Toxicologist, Study Direction
Generate protocols and Animal Care and Use Committee (ACUC) forms ensuring compliance with appropriate SOPs, Good Laboratory Practice (GLP) and regulatory agency guidelines. Initiated study costs and schedules, monitored study activities and assisted study directors with proposal management. Met with clients, both US and international, to discuss study progress and participate in meetings; generated progress and final report preparation.
- Worked on projects to refine and reduce the number of extra animals and blood collection draws proposed in small animal studies. Decreased the number of animals and utilized the Dried Blood Spot technique to obtain the blood needed for analysis; this reduced study costs by 30-35%. Received the 3Rs award in 2009.
- Participated on Six Sigma project to reduce errors in ordering process; this resulted in a streamlined online animal acquisition form that reduced errors by 10%, saving rework time and cost.
- Assisted in developing an assistant/associate toxicologist training manual for new hires.
- Mentored and trained new toxicologists and study directors providing proposal, scheduling, and project guidance through study completion.
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Consulting business providing scientific and regulatory support services to the chemical and pharmaceutical industries and associated regulated community.
- Offered services of toxicology/hazard assessment, environmental toxicology, exposure assessment, environmental and human health risk assessment, program management, position document development, regulatory submissions and strategy.
- Programs and work products have supported new and existing chemical registrations and regulation under EPA (TSCA, FIFRA), FDA, EU and individual EU member states.
- Completed a $1 million toxicology testing program under the High Production Volume Chemicals program for eight metal carboxylates including: review and summary of existing data, and testing for physico-chemical properties, aquatic toxicity, acute mammalian toxicity, in vitro mammalian genetic toxicity, and reproductive/developmental screening studies.
- Supported registration of a new veterinary drug, an antibiotic, for use in catfish aquaculture based on comprehensive hazard, exposure and risk assessments. This was the first "Finding of No Significant Impact" by the FDA Center for Veterinary Medicine for an environmental issue in over 10 years.
- Supported registration of anticoagulant rodenticides for over 8 years. Developed industry position that an EPA "risk assessment" was only a "hazard assessment" and therefore not a basis for regulation. Developed strategy and made industry presentation to EPA upper management; this program resulted in delay of regulatory action for nearly 10 years.
- Supported a new veterinary drug for use in salmon hatcheries by developing a risk assessment based on both calculated and measured exposure and hazard assessments.
- Conducted literature search and prepared hazard assessment for new indirect food additives and metabolites.
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Senior Scientist/research Scientist/assistant Reproductive Toxicologist &study Monitor
As the Study Director/Monitor, designed, conducted, analyzed, interpreted, and reported reproductive and general toxicity studies conducted in-house and at contract facilities. Regularly managed 10 to15 studies in accordance with appropriate GLP standards, relevant SOPs, safety, animal welfare, and international regulations and guidelines. Assisted project teams with problem solving, regulatory submission preparation and inquiry response, and risk assessment. Performed laparotomies, fetal evaluations, neonatal developmental milestone and behavioral testing and other laboratory procedures. Provided all reproductive toxicology laboratory procedure training and recordkeeping for site personnel. Created, performed and reported all site-specific reproductive toxicology computer validation testing procedures.
- Selected interim supervisor of the Reproductive Toxicology Laboratory (supervised 4 employees), following the merger of former Burroughs Wellcome and Glaxo, resulting in continued high-quality laboratory output and elimination of work backlog (approximately 17 studies) in one year.
- Designed, relocated, and set up the new Reproductive Toxicology Laboratory suite and animal room remodeling on time and within budget.
- Received the highest possible performance rating 10 consecutive years (includes early experience).
- Increased rabbit breeding performance from approximately 65% to 90% after taking full control of rabbit breeding operations, greatly reducing the need to repeat studies.
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Toxicologist Laboratory Technician
Inventoried, prepared, and conducted presumptive chemical examination of evidence, including tissue homogenization when necessary.
- Performed routine analytical work and basic forensic and chemical analysis, including determination of volatiles by GC/FID, vitreous humor panels by NOVA Biomedical Analyzer, acid/neutral drugs by GC/MS, levels of carboxyhemoglobin by UV/Vis, and presence of drugs by ELISA as needed.
- Helped develop and validated analytical methods for the NOVA Biomedical Analyzer, Agilent GC/FID, and tissue homogenizer.
- Performed basic lab upkeep including maintaining of lab equipment, glass sterilization and cleaning.
- Prepared buffers, reagents, calibrators, and control standards as needed for analysis.
- Entered, tracked, and processed quality control data for records.
- Routinely updated and authored SOPs.
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Designed and conducted a collaborative project at Duke University investigating the impact of maternal exposure to valproic acid on DNA methylation patterns and subsequent patterns of gene expression in the offspring using the Avy agouti mouse model. Techniques involved include rodent colony maintenance, dissection, DNA/RNA isolation, PCR, Real Time PCR, bisulfite conversion, sequencing, and gene array analysis.
- Evaluated postnatal neurological milestones in humans and animal models to aid development of animal studies that best represent early human brain development for a pharmaceutical company client
- Involved in several projects assessing the risks of chemical weapon destruction products and environmental toxicants, particularly with respect to maternal reproductive and developmental health
- Developed sequencing procedures in several SOPs for molecular biology protocols needed by a government client. Conducted several systems-wide QA audits of laboratories implementing these protocols
- General toxicology instructor for intelligence community client; maintained CIA and DOD SECRET level clearances
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Monitored preclinical GLP (genetic toxicology, developmental and reproductive toxicology and general toxicology) and exploratory studies to evaluate product safety.
- Managed development of animal models designed to predict potential allergenicity of novel
- Managed development of bioinformatics methods designed to predict potential toxicity of recombinant proteins.
- Developed technical safety evaluation reports and publications.
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Responsible for managing, planning and leading complex studies conducted under GLP regulations.
- Performed general supervisory duties including a full range of recruitment and performance evaluations, scheduling, training and executing affirmative action goals in the department.
- Wrote protocols, amendments and reports ensuring compliance with appropriate SOPs, GLPs and regulatory agency guidelines.
- Initiated costings, proposal management, scheduled studies, and monitored the in-life portions of the studies.
- Served as primary contact for key client accounts, developing relationships, providing recommendations and implementing solutions to ensure optimal outcomes.
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Analytical Toxicologist I
Performed quantitative and qualitative analysis of therapeutic and abused drugs for post mortem and investigative cases using liquid-liquid and SPE extraction techniques on GC/MS & LC/MS instrumentation in human biological fluids
- Drugs analyzed include but are not limited to opiates, amines, barbiturates, benzodiazepines, cocaine and metabolites, and THC.
- Troubleshoot and conducted routine and preventative maintenance of GC/MS & LC/MS instruments
- Researched, developed, validated, and write new and improved SOP's for the extraction of therapeutic and abused drugs
- Trained new technicians on proper extraction technique, quantitative analysis, instrument maintenance, submission of reports, and chain of custody practices
- Prepare and validate QC standards and controls
- Researched, developed and validated methods for the detection and identification of new and unusual drug compounds.
- Executed research projects and present or publish results
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Functioned as the lead technologist/supervisor and managed a staff of seven (7) laboratory staff.
- Identified pharmaceuticals, therapeutic drugs, and drugs of abuse in biological specimens utilizing esoteric testing procedures, EMIT assay, thin layer chromatography (TLC), gas chromatography (GC), high performance liquid chromatography (HPLC), and fluorescent polarization immunoassay (FPIA).
- Effectively trained staff on all clinical toxicology procedures and assisted with staff scheduling.
- Reviewed proficiency testing results submitted to regulatory agencies.
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