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Additional Sciences Resume Samples
Toxicologist Resume Samples
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10+ years of experience
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.
10+ years of experience
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.
6-10 years of experience
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.
0-5 years of experience
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.
0-5 years of experience
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.
0-5 years of experience
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
0-5 years of experience
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.
6-10 years of experience
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.
6-10 years of experience
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
6-10 years of experience
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.
0-5 years of experience
Responsible for reviewing and updating Minnesota’s administrative rules setting maximum limits for contaminants in groundwater. Coordinated team of toxicologists participating in review; plan and run public meetings; review toxicological data; and communicate scientific information to the public.
- Coordinated review of toxicological data for over 200 water contaminants.
- Proposed and implemented more stringent contaminant limits protective of children.
- Drafted administrative rule and supporting documentation for publication in state register.
0-5 years of experience
Advised businesses (industrial&customer solutions, resin, monomers) on toxicological assessments and compliance with the requirements of global chemical registrations such as REACh.
- Wrote study summaries, health& safety brochures, read-across arguments, response letter to government agencies; coordinated the conduction of toxicological studies via the Dow lab or external laboratories.
- Learned new developments in toxicology, regulatory toxicology and risk assessment.
- Contributed to Dow’s toxicology research program.
- Responded to external customer inquiries regarding product safety.
- Attended science expert groups and trade association working groups.
0-5 years of experience
- Directed correlation of data in Laboratory Information System (LIS) to be processed with correct method and calibration.
- Recorded and reported data test results promptly and accurately and proficiently before closing each case.
- Tracked and corrected any problems related to reporting of specimens.
- Maintained compliance with CAP and CLIA regulations.
- Competent to analyze data with acute accuracy.
0-5 years of experience
- Managed regulatory compliance and human health risk assessment of Syngenta products (insecticides, fungicides, herbicides).
- Helped in registration and reregistration of Syngenta products by designing and managing required guideline and MOA studies.
- Lead inhalation toxicology science team to evaluate repeat inhalation study strategy from writing waivers, designing appropriate study, placing them at qualified labs, managing/monitoring, to analyzing data and reporting.
- Wrote whitepapers/waiver documents to support reregistration/reregistration of Syngenta products.
0-5 years of experience
Planned, designed and oversaw the execution of new drug candidate safety evaluations; ensure that safety information supports drug development and registration, and met international regulatory requirements
- Prepared safety documentation for submission to regulatory authorities and presentations to senior management
- Represented Nonclinical Safety Department on cross-functional project teams; provided input to project decision-making and development of strategic direction; evaluate in-licensing opportunities
- Preclinical Leader for successful, simultaneous, global accelerated approval of Fuzeon marketing applications for HIV
- Led investigative efforts to resolve project-related issues of hepatotoxicity, neurotoxicity and immunosuppression
6-10 years of experience
Oversaw all toxicological assessments and toxicological testing of selected human and animal health drug candidates, crop protection chemicals and food additives, within company’s portfolio of products. Directed all aspects of studies, including protocol design, scheduling, contract administration, study monitoring, and report writing; compiled summaries of adverse effects (AEs). Evaluated preclinical data on drug candidates from Hoechst AG and Roussell for registration in U.S.; prepared preclinical sections of INDs, NDAs, and drug master files.
- Appointed as departmental representative on cross-functional New Drug Project Committees; served as corporate representative to FDA Bureau of Drugs and Bureau of Foods.
- Designed and negotiated acceptability of special toxicology studies in organ-damaged animals to assess product safety profile of a new artificial sweetener in selected at-risk human populations.
- Managed regulatory affairs functions of a new during development of artificial sweetener, acesulfame K, and represented company at meetings with FDA Bureau of Foods.
- Provided comprehensive, on-site support and regulatory guidance to associates, as well as contract laboratories, in Europe.
6-10 years of experience
- Oversaw LCMS maintenance; maintained daily, monthly, and yearly logs and scheduled maintenance.
- Proposed troubleshooting solutions to management, exceeding production needs and turnaround times.
- Performed daily extractions, transcription, and verification of all LCMS tests
- Train and serve as resource for onboarding new chemists
- Introduced a new testing approach for extracting buprenorphine that revolutionized the organization’s previous extracting method, accounting for nearly half of our daily confirmation tests from an SPE to a liquid-liquid extraction. The newly developed method has saved Calloway hundreds of thousands of dollars in materials and labor, which the organization is still reaping the benefits of.
- Assisted with the switch from LCMS assays to LDTD testing. Perform SPE, Zephyr, and Hamilton extractions.
- Recognized by the CEO for my efforts and awarded the “Glue Man” award for serving as the “glue” that binds our team together
- Currently in charge of smooth operation and workflow of all LDTD testing performed in house
- Experience with API 4000; API 5000 QTrap; Agilent 6400 LCMS; Agilent 1200 series LC; 1260 Infinity Binary LC; Shimadzus.
0-5 years of experience
- Performed and supervised court mandated urine toxicology for felony treatment diversion program
- Perform all data entry into unified court system program.
- Prepared samples for laboratory testing and placed orders for specimen containment units.
- Reported findings to CASAC Counselors and presiding Judge for determination of action.
0-5 years of experience
- Accessioned, aliquoted and prepared patient urine samples to be analyzed by immunoassay and LC/MS
- Analyzed, quantified, and verified data compiled by immunoassay and LC/MS
- Performed minor maintenance and troubleshooting on an immunoassay screening unit and LC/MS
- Worked with coworkers to ensure accuracy of patient results
- Coordinated with other offices within the practice on the shipment of samples to the laboratory
0-5 years of experience
- Ensured the proper testing and analysis of urine, oral fluid, and blood samples in accordance with state and federal laboratory processes and procedures.
- Cleaned and maintained equipment, including microscopes, PH meter, and analytical balance.
- Performed chemical analysis using buffers, eluents, in the extraction and processing of specimens.
- Received recognition during end of year review for overall performance of toxicology testing.
- Collaborated with team members to efficiently meet the required daily quota.
6-10 years of experience
Maintained Drug Safety data collection system as system manager and assisted in Toxicology research activities.
- Updated In-house data collection system to improve user functionality and report formats.
- Created SOPs and tests to ensure system compliance with the FDA’s 21 CFR Part 11 regulations.
- Created documents and guidelines for requesting and testing changes to data collection system.
0-5 years of experience
- Coordinated the Acute Toxicology Testing Program – initiated, monitored, and finalized the acute toxicology battery of studies required for product registration at the US EPA
- Reported adverse effects for all acute toxicology studies
- Designed and implemented a time-saving database containing US EPA regulatory and toxicological endpoints compiled from numerous documents, which eliminated the need to (re)evaluate the toxicology studies and US EPA reviews each time the information was needed
0-5 years of experience
Environmental Consulting & Testing
- Performed and managed sediment and water bioassays, statistical analyses, and chemical analyses in compliance with local, state and federal programs concerning water, ecological and environmental quality.
- Led team on environmental surveys and conducted sample collection for various programs and projects.
- Performed interlaboratory variable testing concerning Whole Effluent Toxicity (WET).
- Served as Expert Observer during dredging as part of Endangered Species Observer Program.
0-5 years of experience
- Conducted over 60 studies in ecotoxicology, determining environmental impacts on biological resources by exploring how pollutants impact the reproduction and growth of fish and invertebrates. Bred and grew test species and evaluated water quality by various testing methods.
- Extracted samples for histological analysis.
- Followed prescribed formats and standard operating procedures for consistent scientific data collection.
- Analyzed scientific data, including statistical analysis, to determine significant results on growth or reproduction from pollutants for use in a variety of genera.
- Collaborated on scientific data reports according to Environmental Protection Agency (EPA) guidelines.
0-5 years of experience
Conducted review of environmental and health data to determine, if health risks are posed from exposure to environmental contaminants.
- Prepared health documents including health advisories, consultations and assessments.
- Engaged with communities to relay findings and conduct public health follow up activities.
- Developed recommendations for public health actions.
- Served as expert toxicological resource for the branch.
0-5 years of experience
- Drafted technical documents such as study protocols, CTD tables, data tables, and reports
- Managed studies in compliance with appropriate regulations (FDA, ICH, OECD, and GLP)
- Maintained and enhanced knowledge of regulatory guidelines and industry standards
- Interacted collaboratively between external and internal partners
6-10 years of experience
- Prepared risk assessments and exposure modeling.
- Assessed safety data and prepared toxicological summaries for chemicals of concern.
- Conducted product toxicity studies.
- Performed Quality Assurance function for community based health survey.
0-5 years of experience
- Developed novel alternatives assessment methodologies for green chemistry
- Developed and maintained 125+ regulatory databases in (eco) toxicology and physical chemistry
- Provided regulatory toxicology consulting services for clients ranging from cosmetics to industrial
0-5 years of experience
- Published four peer-reviewed scientific manuscripts and a graduate thesis.
- Drafted protocols for complex laboratory techniques; as well as safety and animal husbandry
- Presented at national and international conferences.
0-5 years of experience
- Performed immunoassay screens on urine and blood for drugs of abuse
- Executed analytical confirmatory tests by GC-MS
- Prepared and analyzed Vitamin D blood analysis by LC-MS/MS
0-5 years of experience
Safety evaluation and approval of raw materials and finished products
- Regulatory compliance with global safety requirements for cosmetic ingredients and L’Oreal internal standards, collaborating with foreign affiliate colleagues
- Prepared risk assessments to support the use of raw materials for clinical testing and in marketed products
- Trade organization representative for L’Oreal to industry working groups and task forces
0-5 years of experience
- Checking in patients and scheduling appointments
- Taking vital signs, urine samples, and drawing blood from patients
- Checked vital signs, injections, obtained medical/family history, and chief complaint, E-Clinical EMR charting system
- Performed EKG’s, injections, while assisting doctor with patient charting and referrals
- Answered phone calls and scheduled patient appointments
0-5 years of experience
- Obtained Forensic Alcohol Analyst certification (January 2009)
- Completed testing in all areas of the forensic toxicology laboratory, including drugs of abuse screening and confirmation, alcohol quantification, and prescription drug identification and quantification
- Utilized various extraction, derivitization, column separation, GC-MS and LC-MS techniques to isolate, identify, and quantify analytes of interest
- Gained experience troubleshooting and maintaining toxicology instrumentation
- Educated other toxicologists and office staff of biohazard handling and disposal, contamination minimization, and information security as the only non-supervisory Medical Technologist on staff
0-5 years of experience
Vendor management to contract research organizations with regards to all outsourced in vivo animal studies conducted by the company. Study design, contract and protocol review, project management, invoicing and data analysis.
- Primary point of contact to company for vendors/CRO support for in vivo animal studies.
- Expertise in cross functional relationships between Senior Management, R&D, CRO, Business Development and Project Management.
- Collaborate with Project Management to ensure all timeline deliverables are met.
- Research, trouble shoot, and optimize all preclinical studies.
- DEA Site Specialist for the Warren, NJ laboratory. Oversee all aspects of registration, security compliance, record keeping and employee training.
- EHS Site Specialist for the Warren, NJ laboratory. Maintain all OSHA and DEP compliance and record keeping, perform safety inspections, monitor hazardous waste management, facilitate all employees to receive required training.
6-10 years of experience
Analyzed items of evidence submitted for analysis for the presence of alcohol or other intoxicating substances in biological specimens
- Testified as an expert in court and/or administrative hearings concerning the results of forensic examinations
- Performed administrative and/or technical reviews of criminalistic examination reports
- Operated and maintained instrumentation such as LC-MS/MS, GC-MS, and ELISA to obtain analytical results
0-5 years of experience
Worked with post-mortem specimen receipt, preparation, and analysis for the presence of drugs.
- Conducted initial analysis of GCMS data.
- Prepared calibration and control solutions for testing.
- Worked with complex matrices such as blood, urine, bile, brain, and liver.
- Performed solid phase and liquid-liquid extractions.
- Followed established chain of custody procedures.
- ABFT certified medical examiner laboratory.
- Operation and troubleshooting of GCMS instrumentation.
0-5 years of experience
- Interviewed and wrote incoming clients bio-social history.
- Facilitated groups and aided clients in participation.
- Assisted clients with goal setting.
- Admitted urine samples of 189 clients twice a week.
- Submitted group notes and weekly progress notes to director.
- Engaged in one on one sessions with caseload clients.
- Informed parole,probation and ACS Government officials of clients
0-5 years of experience
Provide clinical analysis and evaluation of biological specimens (urine, oral fluid) for drugs that are a part of a prescription regimen and/or for drugs of abuse.
- Initial testing/immunoassay instrument operation and trouble shooting.
- LC/MS/MS maintenance, operation, interpretation and trouble shooting.
- Proficient in Pharmacology and drug metabolism.
- Uses QuikLIMS (Laboratory Information Management Systems) and MassHunter software computer systems to process data, chromatography and certify toxicological reports.
- Works within a certification team to ensure proper turnaround time for participating clients.
0-5 years of experience
Dual role at the same time as being a Study Director
- Responsible for hiring, training and executing department goals and objectives.
- Conducted peer reviews and managed the report process for multiple people and studies.
- Capable of handling many responsibilities at a time. Expert at multi-tasking.
10+ years of experience
Perform complex drug quantitations using solid phase and liquid/liquid extraction methods
- Operate, maintain, and troubleshoot GC/MS, GC, and LC/MS/MS instrumentation
- Analyze and interpret data for forensic toxicology reports
- Perform legal blood alcohol analysis for law enforcement and autopsy cases
- Hazardous Chemical Safety Team: in charge of inventory, ordering, and waste disposal
- Routinely prepare chemical reagents using excellent laboratory techniques
6-10 years of experience
- Author human health risk assessments based on toxicological data and communicate results to global
- Provide Toxicology guidance for domestic and international legal/regulatory activities to support product
- Develop safety testing strategy, design relevant testing protocols and interpret toxicology data for regulated and non-regulated consumer products (ex. pesticides, OTC drugs, personal protective
- Support global business growth and innovation through cross-functional projects enabling competitive
- Provide technical guidance on product safety-related issues impacting manufacturing and end users in support of corporate Quality and Regulatory initiatives.
- Train internal and external stakeholders on product safety protocols and procedures.
6-10 years of experience
Oversee testing of blood, urine, autopsy samples in accordance with American Board of Forensic Toxicology standards.
- Accessions, analyzes, and reports 9,000 forensic and national interest cases for Department of Defense’s sole forensic toxicology laboratory.
- Manages operations in the processing and analysis of aircraft incident, fatality, and investigative cases from 1,700 departments.
- Examines specimens and secure chain of custodies vital to the Armed Forces Medical Examiner System.
0-5 years of experience
- Breed, feed and maintain aquatic animals used in testing
- Administer and observer testing materials for our clients for chronic or acute symptoms
- Sanitize and maintain all equipment and work place environment to ensure to accurate results
- Create different mediums and chemicals for feeding, housing and testing
- Recorded all finding and ensure that all processes follows all government protocol
0-5 years of experience
Perform complex chemical extractions on donor urine for GC/MS and LC/MS testing
- Perform drug confirmation extractions using quality control protocol and SOP guideline.
- Verify chain of custody and specimens received.
- Perform equipment maintenance and lab supplies/reagents inventory.
- Document chain of custody transfers.
0-5 years of experience
- Conduct quantitative risk and exposure assessments for regulatory submissions and successful settlements
- Provide expert witness and litigation support on Prop 65 Notice of Violations for consumer products
- Created profile database on chemical compounds used in consumer while filling data gaps when necessary
- Review critical reports relating to chemical control regulation
- Serve as a manuscript reviewer for professional manuscripts
- Plan and design experimental safety testing methodologies on consumer products with CROs
- Liaise findings with non-scientific legal counsel, external experts and regulators while developing strategies for continued testing on consumer products.
0-5 years of experience
Assured CDA & Contracts in place. Monitor GLP nonclinical toxicology studies. Write monitoring (audit) reports
- Conduct qualification inspections of CROs. Negotiate study cost and timelines; studies were kept within budget
- Perform literature searches and assist in preparation of the Pharm/Tox Section of NDA submission
- Review CRO protocols and reports. Assured tracking of studies. QC study report data. Write SOPs and revisions
0-5 years of experience
Serve as study director on acute and chronic Daphnia magna studies.
- Maintain accurate records for all data collections utilities.
- Prepare routine reports and data summaries of completed projects for incorporation into final reports.
- Develop study protocols according to testing facility guidelines.
- Assist in the training and orientation of staff to laboratory techniques.
- Work collaboratively with others to maintain a safe environment.
- Maintain awareness of accident prevention practices.
0-5 years of experience
Global chemical regulatory monitoring.
- Composing regulatory analysis summary for emerging regulations and regulatory updates.
- Global product stewardship.
- Regulatory assessment on client products.
- Serving as China liaison on product importation permitting for a confidential client.
- Classification of client products based on the Globally Harmonized System (GHS) and country-specific requirements.
0-5 years of experience
- Maintain and calibrate laboratory equipment (Olympus 5400, Rudolph, atago and pH meter)
- Ensure results are properly entered into computer system
- Prepare reagents, quality controls and other solutions for laboratory use following a standard procedure
- Provide proper chain of custody techniques