Toxicologist Resume Samples

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IL
I Leuschke
Itzel
Leuschke
543 Reinger Parkway
Chicago
IL
+1 (555) 909 7816
543 Reinger Parkway
Chicago
IL
Phone
p +1 (555) 909 7816
Experience Experience
Houston, TX
Toxicologist
Houston, TX
Lemke-Steuber
Houston, TX
Toxicologist
  • Work proactively with cross-functional teams to ensure product safety is considered early in the development process
  • Coordinate and perform data analysis and prepare test reports
  • Working knowledge of Good Laboratory Practices regulations
  • Analyze and evaluate problems to develop sound experimental techniques for scientific studies
  • Design and manage toxicology research under Good Laboratory Practices (GLP) regulations
  • Design and manage toxicology research as a Study Director/Principal Investigator
  • Responsible for providing non-clinical safety support to in-licensing review teams
Houston, TX
Staff Toxicologist
Houston, TX
Nikolaus-McLaughlin
Houston, TX
Staff Toxicologist
  • Guides and develops the technical foundations of policies, procedures and initiatives to ensure development of consistent processes
  • Integrate with multiple functions across Boeing, including engineering, supplier management, Legal, government affairs, internal governance, etc
  • Participate in the proposal and bid development process
  • Proactively identify future biological safety challenges and develop strategies to address them
  • Perform other duties as assigned
  • Work Collaboratively with scientists, engineers, and regulatory specialists in multidisciplinary project teams
  • Review product safety data, identify gaps and perform risk analyses
present
New York, NY
Senior Toxicologist
New York, NY
Connelly-Klocko
present
New York, NY
Senior Toxicologist
present
  • Providing technical guidance to other 3M staff groups involved with regulatory and hazard communication issues for assigned businesses
  • Development of recommendations and draft reports
  • Development of technical publications, presentations at conferences, and proposal sections
  • Development of tools, guidance materials, and other resources
  • Review of work produced by others
  • Critical analysis and evaluation of toxicology studies, including study quality determination and identification of studies for dose-response analysis
  • Determination of chemical mode of action, including adverse outcome pathways
Education Education
Bachelor’s Degree in Toxicology
Bachelor’s Degree in Toxicology
University of Oregon
Bachelor’s Degree in Toxicology
Skills Skills
  • Ability to prioritize, multi-task, and work under strict deadlines in a fast-paced environment
  • Strong analytical skills
  • Strong written and oral communication skills
  • Excellent organizational and time management skills
  • Attention to detail
  • Be able to contribute positively to the social environment in the department
  • Demonstrate excellent presentation and communication skills and build trust with colleagues and stakeholders
  • Be a team-player while still having a strong drive to push forward and create results within tight deadlines
  • Proactive and problem-solving approach to challenges
  • Experience with addressing Adverse Outcome Pathways using in vitro techniques would be considered an advantage
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15 Toxicologist resume templates

1

Toxicologist Resume Examples & Samples

  • Research and data collection using peer-reviewed literature, on-line data sources, technical reports, and other sources
  • Critical analysis and evaluation of toxicology studies, including study quality determination and identification of studies for dose-response analysis
  • Determination of chemical mode of action, including adverse outcome pathways
  • Synthesis of information from multiple data streams (i.e., in vivo and in vitro) to support hazard, dose-response, and risk conclusions
  • Identification and analysis of data gaps
  • Development of recommendations and draft reports
  • Development of tools, guidance materials, and other resources
  • Interaction and correspondence with clients
  • Review of work produced by others
  • Development of technical publications, presentations at conferences, and proposal sections
  • Mentoring and training other technical staff
  • Advanced degree in toxicology, pharmacology, physiology, biochemistry, molecular biology, environmental health or related subject with focus on human health hazard and risk assessment
  • PhD plus 2 years of experience or Master’s degree plus 5 years of experience
  • Experience assessing human health impacts of chemicals
  • Experience with government regulatory programs (preferably U.S. EPA)
  • Proactive and problem-solving approach to challenges
  • Strong analytical skills
  • Strong written and oral communication skills
  • Excellent organizational and time management skills
  • Attention to detail
  • Ability to prioritize, multi-task, and work under strict deadlines in a fast-paced environment
2

Senior Toxicologist Resume Examples & Samples

  • Research and data collection using peer-reviewed literature, on-line data sources, technical reports, and other sources
  • Critical analysis and evaluation of toxicology studies, including study quality determination and identification of studies for dose-response analysis
  • Determination of chemical mode of action, including adverse outcome pathways
  • Synthesis of information from multiple data streams (i.e., in vivo and in vitro) to support hazard, dose-response, and risk conclusions
  • Identification and analysis of data gaps
  • Development of recommendations and draft reports
  • Development of tools, guidance materials, and other resources
  • Interaction and correspondence with clients
  • Review of work produced by others
  • Development of technical publications, presentations at conferences, and proposal sections
  • Mentoring and training other technical staff
  • PhD in toxicology, pharmacology, physiology, biochemistry, molecular biology, environmental health or related subject with focus on human health hazard and risk assessment
  • 10+ years of experience
  • Experience assessing human health impacts of chemicals
  • Experience with government regulatory programs (preferably U.S. EPA)
  • Proactive and problem-solving approach to challenges
  • Strong analytical skills
  • Strong written and oral communication skills
  • Excellent organizational and time management skills
  • Attention to detail
  • Ability to prioritize, multi-task, and work under strict deadlines in a fast-paced environment
3

Senior Toxicologist Resume Examples & Samples

  • 10-15 years related experience
  • Graduate training and experience in Industrial Toxicology (DABT certified, preferred)
  • Documented skill in quantitative risk assessment of chemicals and materials
  • Documented skill in structure activity analyses and predictions
  • Documented experience in the review, assessment and application of toxicology studies in both humans and animals. Documented understanding of global regulations applicable to materials and chemicals
  • The ability to understand business and apply these technical skills to IBM's global operations
4

Principal Toxicologist Resume Examples & Samples

  • The incumbent will document and provide accurate hazard identification, exposure characterization, safety assessment and product safety guidance for medical devices and consumer products globally (with a primary focus on medical devices in the North America region). The incumbent is required to design, communicate and implement product safety strategies in alignment with regulatory strategies and quality systems for new products and represent the GPS department on multi-functional technology, product development, and post-market support teams. The incumbent will author and communicate product safety and regulatory toxicology compliance information, safety point-of-view papers and human health risk assessments to internal and/or external technical experts, regulatory reviewers as well as functional and business unit leaders and management
  • The incumbent will lead and/or manage the design, monitoring and interpretation of chemical characterization analyses, pre-clinical toxicology, biocompatibility and microbiological safety studies conducted under Good Laboratory Practices (GLP), and when applicable, clinical studies conducted under Good Clinical Practices (GCP). The incumbent will document, author and disseminate human health safety (risk) assessments taking into consideration identified hazard, user or patient exposure according to intended product use or foreseeable misuse
  • The incumbent will participate in the life-cycle management of KCC medical devices and consumer products globally (with a primary focus on medical devices in the North America region) through the review of post-market surveillance data and other information as gathered by or disclosed to Kimberly-Clark. This may result in the incumbent developing responses to safety-related internal or external customer inquiries and the development of safety-related statements, policies or other documentation for internal or external distribution in collaboration with Regulatory, Medical Sciences, Quality, Corporate Communications and/or Legal
  • The incumbent is expected to understand and anticipate business unit requirements and/or needs and work collaboratively with the product development and manufacturing communities and other compliance functions such as Quality, Regulatory, Clinical Affairs, Medical Sciences and Legal. He/she is expected to effectively communicate assessments or scientific information to technical, program management and business communities. If necessary, he/she is required to effectively communicate and advocate product safety-related positions and influence scientific thought with global regulatory bodies, Key Opinion Leaders, non-governmental organizations, and trade associations and in support of potential litigation situations
  • The incumbent will conduct themselves in accordance with expected Kimberly-Clark leadership behaviors and corporate policies and procedures with an expectation to maintain and enhance their technical, professional, leadership and communication skills through continuing education and professional development courses, attendance and participation in scientific conferences and meetings, publication of appropriate work in peer-reviewed journals and other aspects of technical and leadership development. He/she will also participate on cross-departmental teams to contribute to the development or revision of departmental policies and procedures
  • Degree in toxicology, biomedical or related field of relevant product safety experience in the design, development, regulatory clearance/approval and maintenance of medical devices in global markets
  • O Bachelor’s degree with 7+ years of experience, or
  • Demonstrated ability or willingness to develop subject matter expertise in microbiology/microbial sciences and women’s health
  • Strong interpersonal skills, technical leadership and demonstrated proficiency as an effective contributor to research or product development teams. Demonstrated ability to independently manage multiple projects in a corporate setting and the ability to effectively communicate in written or oral presentation formats
  • Ability to travel up to 20-30% (domestic and international)
  • LI-POST
5

EPA Environmental Toxicologist Resume Examples & Samples

  • M.S. or Ph.D. in Environmental Toxicology, Ecotoxicology or related field
  • Minimum of 7 years experience
  • Experience with FIFRA
  • Experience with environmental exposure and risk assessment for pesticides
  • Research publications in peer-reviewed journals related to ecotoxicology
6

Investigative Toxicologist Resume Examples & Samples

  • Assist in developing and delivering an over-arching strategy for the delivery of toxicology, which may include internal resource and/or external partners
  • Aid in the development of a forward facing vision of the non-clinical sciences department, and support implementation of this vision
  • Provide internal expertise to understand the mechanisms of toxicity observed non-clinically and/or clinically in order to drive mitigation and/or back up strategies to minimize harm to patients
  • Build collaborative networks internal and external to the company to ensure rapid communication and cross functional investigation of emerging safety issues
  • Present data and interpretations in written and oral form to regulatory bodies to enable optimal clinical development and registration of novel drugs
  • Act as a non-clinical team representative responsible for the non-clinical safety strategy of novel target/therapeutic candidates. Your ability to understand the toxicity of the platform versus target related toxicities is key
  • Develop strong knowledge of the basic biology of the intended target of drug candidates
  • Represent Seattle Genetics in the external scientific environment – influencing partners and regulators in a positive way
  • DABT (or equivalent)
  • PhD
  • Proven success in scientific investigation of fundamental biology questions, either through scientific publications or drug development experience
7

Toxicologist Resume Examples & Samples

  • Planning toxicology operations in support for a given project
  • Organizing and monitoring toxicology studies done in CRO
  • Writing and organizing the preclinical dossier of submission in a given project
  • Lead multidisciplinary pre-clinical activities in given projects
  • A high academic degree (Ph.D., or equivalent) in Toxicology, Pharmacy, Pharmacology, DVM or a related field
  • Excellent verbal and writing communication skills
  • Experience in Industry as a toxicologist
  • Knowledge of regulatory toxicology and of the submission process
  • Preferably an accredited or registered toxicologist
  • A good understanding of related preclinical disciplines (e.g, ADME, Pharmacology, Biological Method Development)
  • Ability to lead multidisciplinary teams in a matrix organization
8

Toxicologist Resume Examples & Samples

  • Design and manage toxicology research as a Study Director/Principal Investigator
  • Design and manage toxicology research under Good Laboratory Practices (GLP) regulations
  • Analyze and evaluate problems to develop sound experimental techniques for scientific studies
  • Coordinate and perform data analysis and prepare test reports
  • Present data at client meetings or conferences
  • Train and mentor junior technical staff
  • Prepare cost and schedule estimates on proposed projects/assays in toxicology
  • Work around or with hazardous materials may be required and would be performed by following all safety guidelines to minimize exposure
  • DABT Certification
  • Experience working with extremely hazardous chemicals/biologicals
  • Knowledge of US Army rules and regulations surrounding chemical/biological agent operations
  • Understanding of GLP and ISO regulations
9

Product Stewardship Toxicologist Resume Examples & Samples

  • Master's degree in related discipline
  • 5 - 10+ years of related work experience
  • Chemical or allied industry experience
  • Knowledge of industrial organic chemistry
  • Regulatory affairs/product safety experience
  • PhD is highly preferred
  • Regulatory experience in industrial chemicals and polymers is preferred
10

Principal Scientist Regulatory Toxicologist Resume Examples & Samples

  • Integration of toxicology, human food safety, target animal safety, user safety and environmental assessments into submission documents
  • Response to regulatory queries (Global)
  • Toxicological assessments for residual solvents, excipients, impurities in the manufacturing process
  • Medical assessments supporting pharmacovigilance and product quality
  • User safety support for project teams (writes the documents, assembles various scenario calculations and risk mitigation proposals, packaging choice, label language)
  • Safety Expert Reports for registration renewals
  • Manufacturing: May aid in assessment of out of specification batches, segregation assessments, cleaning limits
  • Environmental Risk Assessments: potentially work with environmental risk assessments including project strategy, document preparation, contracting and monitoring studies, study report review
  • Occasional travel: <15% depending upon study involvement
  • PhD (or equivalent) plus at least 5 years of experience in a related field such as toxicology, pharmacology, environmental science is critical
  • Demonstrated skills in technical writing (protocols, reports, journal articles)
  • Some experience in writing regulatory toxicology and/or environmental safety dossiers, as well as experience in the design, implementation, and interpretation of studies evaluating in vivo toxicity or similar experience would be expected
  • The candidate should have excellent organizational and communication (verbal and written English) skills, and the ability to work and be effective in a demanding team environment of a global company
  • Board certification in toxicology
  • Knowledge of global regulatory requirements for the preparation of toxicology to support human food safety filings, and user safety assessments
  • Some familiarity with environmental assessments and with internationally accepted mathematical models used to predict concentrations of product active ingredients in the environment would be strongly considered
  • Experience in conducting studies in a regulated environment (GLP-compliance) is desirable
11

Senior Toxicologist Resume Examples & Samples

  • Providing division toxicology support to assigned 3M business units, particularly health care businesses, including technical guidance to product development and product responsibility teams, preparation of hazard/risk assessments and coordination of toxicity testing
  • Serving as Study Monitor for toxicology studies on 3M chemistries/products at contract research laboratories
  • Communication of toxicity testing and risk assessment results to internal, as well as external customers and scientific/regulatory groups through oral presentations and written reports/publications globally
  • Providing technical guidance to other 3M staff groups involved with regulatory and hazard communication issues for assigned businesses
  • Other duties as assigned
  • Master’s degree or higher from an accredited university
  • Minimum of five (5) years’ experience related to the conduct/design of mammalian toxicology studies and/or human health risk assessment
  • Ph.D. in Toxicology, Pharmacology or closely related discipline from an accredited university
  • Minimum of ten (10) years of applicable toxicology experience
  • Strong chemistry background also preferred
  • Board certification (DABT or equivalent)
  • Experience with evaluation of medical devices, drugs, combination products, and food safety products according to US and international regulatory standards, such as ISO 10993
  • Experience as a toxicology study monitor at contract research laboratories
  • Experience with the human health hazard evaluation/risk assessment process for new chemistries
  • Experience communicating toxicology results or human health hazard/risk assessments through both oral and written methods
  • Experience/Ability to work in a multi-disciplinary environment with good analytical, interpersonal, and professional judgment skills
  • Excellent written, verbal communication skills and strong organizational abilities
  • 3M is an equal opportunity employer. 3M will not discriminate against any applicant for employment on the basis of race, color, national origin, religion, sex, sexual orientation, gender identity, age, disability, or veteran status
12

Drug Development Toxicologist Resume Examples & Samples

  • Plan and manage nonclinical development activities for drugs, biologics, or devices for clients
  • Assist senior staff in providing nonclinical and toxicology guidance for client projects
  • Prepare planning, strategy, summary documents, etc. for use in communicating with Sponsors
  • Prepare or assist in preparation of nonclinical sections of regulatory documents and INDs
  • Working with a project manager, ensure maintenance of each development program’s applications, documentation, per regulations
  • Ensure CRO and consultant deliverables and activities are prepared or conducted on time and of high quality
  • Review study protocols, reports and related documents for compliance with regulatory requirements and good scientific principles
  • Act as Study Monitor or Sponsor representative for contracted nonclinical studies
  • Ensure compliance with GLP, GMP, and regulatory guidelines
  • BS degree in toxicology, biology, chemistry or related field with 6 or more years of experience, MS with 3 or more years of experience, or PhD with 0 or more years of experience in drug development activities. DABT certification a plus
  • Experience managing and/or monitoring nonclinical development activities, reviewing/writing protocols and study reports
  • Excellent oral and written communications skills and ability to communicate effectively with external clients
  • Awareness of or experience with regulatory submissions including IND briefing documents and IND applications
  • Solid understanding of GLP requirements and ICH guidelines
  • Demonstrated ability to work as a member of multiple project teams, and negotiate and achieve consensus in diverse groups
  • Ability to prioritize and multi-task concurrent project demands
  • Must be legally authroized to work in the United States and not require sponsorship now or in the future
13

Human Health Toxicologist Resume Examples & Samples

  • Review and evaluate toxicological data from laboratory studies for possible use in developing threshold values
  • Write technical reports and summaries of toxicological reviews and analyses
  • Evaluate analyses of human health data for purposes of developing threshold value
  • Education to include a degree(s) in toxicology, epidemiology, statistics, or related scientific disciplines relevant to human health risk assessment
  • Experience characterizing dose-response relationships, including benchmark dose modeling, specialized cancer modeling, and dose-response modeling of epidemiological data is a plus
  • Candidates with Board Certification in General Toxicology are preferred
14

Corporate Toxicologist Resume Examples & Samples

  • Assess APIs, intermediates, impurities for allowable daily exposure (ADE) / permitted daily exposure (PDE) according to guidelines of FDA / EMA in close cooperation with Quality Assurance (QA). Write and sign formally correct scientific reports
  • Assess APIs, intermediates, impurities for allowable occupational exposure levels (OEL) such as AHSK (Arbeitshygienische Stoff-Kategorie) in close cooperation with Occupational Hygiene Visp. Write comprehensive rationale
  • Document all correspondence, findings and reports in CISWEB EHS AHSK Database and in corresponding chemical substance folder
15

Discovery Toxicologist Resume Examples & Samples

  • Provide pharmaceutical drug project teams with expert advice and direction to improve the quality of therapeutics selected for further development based on proactive risk assessment of target- and chemotype-related toxicities
  • Develop comprehensive safety target reviews with risk mitigation plan for early drug discovery project teams based on literature, bioinformatics, and other predictive tools
  • Apply state of the art in silico and in vitro de-risking strategies to aid in the selection and optimization of large and small molecule therapeutics
  • Lead the development of early hypothesis-driven investigation into mechanisms of toxicity for the proactive management of potential safety liabilities and communication of impact to teams
  • Minimum of MS with 8 years of pharmaceutical experience or PhD in a scientific discipline with 3 years postdoctoral experience and/or 5+ years of experience working at a pharmaceutical company
  • Passion to decrease safety related attrition in drug discovery
  • Demonstrated experience and ability to work effectively in a matrix, global environment as part of a multidisciplinary team
  • Broad scientific knowledge including pharmacology, toxicology, pathology, physiology and biochemistry
  • Strong interpersonal and organizational skills
  • Excellent oral and written communication skills
16

Principal Global Mammalian Toxicologist Resume Examples & Samples

  • Provide team leadership, technical expertise, and strategic oversight of contract laboratories to ensure high quality data, sustainable scientific databases, effective interpretations, toxicology recommendations,and advocacy documents for insecticides, herbicides, fungicides, and biological products
  • Provide leadership, sound decision-making, project management, personnel support, and career development for Toxicology Team members located in USA, UK, and Denmark
  • Foster teamwork and collaborations, yet also provide individual contribution and critical-thinking to develop creative mammalian toxicology solutions that meet business objectives
  • Mentor mammalian toxicology staff and train other Global Regulatory Sciences team members on new toxicology, regulatory, or risk assessment developments
  • Serve as internal and external mammalian toxicology expert/specialist for broad knowledge to support a portfolio of active ingredients pesticides and biological plant health solutions
  • Promote sound decision-making needed to develop high-quality, compliant toxicology studies. Be knowledgeable in global toxicology and risk assessment pesticide registration requirements
  • Conceive, plan and oversee the work of contract research organizations (CRO) for all mammalian toxicity testing to meet global (USEPA, OECD, China, Brazil) regulatory requirements and product safety concerns
  • Act as Study Monitor of CRO for long term (sub-chronic and chronic) and complex toxicology studies (developmental/repro, mechanism of toxicity) for EPA, EU, and other regulatory agencies including protocol design, test material transmittal, oversight of contract scientists, critical evaluation of data, and working with QA and contract scientists to provide final reports
  • Review and summarize in-house toxicological study data and literature to prepare critical scientific reviews, chemical hazard and risk assessments, “white paper” advocacy documents, scientific rationales, position statements or monographs for the defense and growth of FMC products. Define and work to resolve major, complex problems coming from interactions of pesticides and a variety of mammalian physiology systems
  • Make recommendations on path forward in the registration of active ingredients or formulations technologies based upon toxicology data and regulatory requirements. Contribute to the development and execution of product defense strategies using toxicology and physiology knowledge and interactions with other scientific disciplines
  • Continually pursue creative low-cost, high-value streamlining, and time-centered initiatives for the development of compliant toxicology data
  • Understand and alert management and business customers about regulatory toxicology initiatives that will shape the regulatory environment for FMC products and our industry
  • Represent FMC and AGS Toxicology at professional meetings, training and workshops, and industry task forces to maintain and improve technical skills and professional connections. Publish or present scientific information at meetings and in peer-reviewed journals
  • Broad scientific knowledge in mammalian toxicology, physiology, and/or veterinarian medicineExpert knowledge of toxicology studies (design and interpretation of data generated) required for regulatory Agencies, especially long-term and specialized, complex study types
  • Experience managing and leading a small, diverse, global scientific team and completing workload to meet tight deadlines and Agency requirements
  • Strong leadership and interpersonal skills including negotiation, conflict resolution, influencing and motivating
  • Working effectively within a team environment – leading, exchanging ideas with colleagues, sharing workload, and interacting with upper management
  • Project management for self and team, including ability to organize, schedule, and prioritize workload and manage external contract scientists, to meet deadlines for concurrent projects
  • Strong analytical capability to analyze data, process information and provide recommendations to key staff and management
  • Experience communicating with non-science, business customers and global Registrations Managers and meeting their expectations
  • Excellent oral and written communication skills, including scientific reports, hazard evaluations, and position papers. Computer literate, experience with Microsoft Office products
  • Track record of effective interactions with Regulatory agencies in the US, Europe, or globally through white papers or in-person meetings
  • Knowledge and use of human health and worker Risk Assessment Models
  • Ability to work with senior management to manage resources and meet timelines
  • Strong commitment to and awareness of safety practices
17

Staff Toxicologist Resume Examples & Samples

  • Participate in the proposal and bid development process
  • Serve as a key contact for sponsors
  • Participate in and coordinate all phases of the study planning process with Client Services and technical and laboratory support operations
  • Responsible for study design and generation of protocols
  • Interpret study data
  • Develop and foster business relationships
  • Post Doctoral experience and DABT preferred
  • Attention to detail and excellent interpersonal and communication skills
18

Toxicologist Resume Examples & Samples

  • Support our discovery group in the safety testing of lead compounds, including introduction of new testing paradigms
  • Design, supervise, interpret, and report in vitro and in vivo nonclinical toxicology IND enabling studies and studies supporting more advanced clinical stages
  • Participate in the preparation of preclinical texts for worldwide regulatory submissions, including authoring the nonclinical safety components of regulatory dossiers (e.g. IB, INDs, NDAs) and communications as well as responses to inquiries from regulatory agencies
  • Work closely with internal functional groups such as Pharmacology, ADME-PK, CMC, Regulatory Affairs, Clinical Development, and Program Management, and actively participate in team strategy discussions for drug development programs
  • Lead teams of preclinical experts in respective projects
  • Responsible for providing non-clinical safety support to in-licensing review teams
  • DVM or PhD in pharmacology, toxicology, or related scientific discipline. Board certification (DABT) is a plus
  • 8+ years of relevant industry experience in toxicology, supporting drug discovery, research and development
  • Proficient knowledge of general toxicology and related disciplines
  • Experience with in vitro assays utilized in discovery and toxicological assessment
  • Familiar with regulatory toxicology guidelines, requirements and standards (GLP, OECD, ICH, CTD, etc.) and able develop nonclinical strategies that support clinical development
  • Experience in authoring nonclinical components of regulatory dossiers
  • Independent self-starter with the ability to work in a matrixed, cross-functional, team-based drug discovery/development environment
  • Excellent verbal and written communication skills; ability to communicate clearly and effectively with scientific colleagues and senior management
19

Staff Toxicologist Resume Examples & Samples

  • Plan and oversee in-vivo and in-vitro toxicological and biocompatibility studies that comply with national and international standards (ASTM, ISO…)
  • Review product safety data, identify gaps and perform risk analyses
  • Respond to notified bodies (FDA, BSI, CFDA, PMDA..) questions in a timely and thorough manner
  • Write toxicological assessment and biological evaluation reports
  • Work Collaboratively with scientists, engineers, and regulatory specialists in multidisciplinary project teams
  • Proactively identify future biological safety challenges and develop strategies to address them
  • Thorough knowledge of current global toxicological guidelines (USP, JP, Ph., Eur., etc.)
  • In depth knowledge of ISO 10993 standards
  • Working knowledge of analytical chemistry
  • Knowledge of orthopaedic / pharmaceutical industry desired
  • Ability to work within a multidisciplinary team setting with good interpersonal skills
  • MS or PhD degree in Toxicology (DABT certification a plus)
  • 5-8 years industrial experience, preferably in contract laboratories
20

Toxicologist, Product Safety Resume Examples & Samples

  • Conduct robust safety assessments that meet global regulations on raw materials and finished formulations for a category of products (e.g. Skin, Hair, Make-up or Fragrance) including OTC products
  • Evaluation of ingredients, raw materials and formulations for internal and external labs based on risk assessments conducted and communicate safety approvals through product specific meetings
  • Assist with compiling and reviewing of Cosmetic Safety Reports for compliance with EU and other global regulations
  • Provide appropriate in vitro and clinical safety support for finished products
  • Conduct literature searches as needed to generate robust safety assessments
  • Proactively participate in discussions on internal safety positions
21

Principal Toxicologist Resume Examples & Samples

  • Consulting industry experience (preferred) with extensive knowledge of toxicology, public health assessments and human health risk assessments related to chemical and microbial risks
  • Experience with of Australian chemical regulatory frameworks (e.g. NICNAS, APVMA)
  • Experience providing expert testimony at hearings
  • High level project and project team management skills
  • A relevant post graduate qualification in toxicology, public health or a similar field
  • DABT (desirable) or potential to seek toxicological certification
  • High industry profile within the public health, regulatory and toxicology/risk practice areas
22

Senior Project Toxicologist Resume Examples & Samples

  • Bachelors degree in a relevant scientific discipline
  • Significant experience (>3 years) as a project toxicologist across a broad range of stages in discovery and development
  • Non-clinical capability and experience coupled with an understanding of the interrelationships between disposition, safety and on/off target engagement as applied to the identification and articulation of critical needs and deliverables for projects
  • Experience in influencing scientific strategy and delivery for projects through a breadth of scientific knowledge of Drug Discovery and Development - experience in coaching/mentoring others in this respect
  • Experience in the application of non-clinical safety knowledge and tools in the integrated design, optimization and selection of quality driven candidate molecules and worldwide regulatory requirements for drug development and registration
  • Desirable to have experience of overseeing a portfolio of projects with assigned PTMs with variable levels of experience and background capabilities.Ability to work collaboratively in a highly matrixed, global organization
  • Demonstrated effective interpersonal, communications and negotiation skills for a wide variety of audiences, including senior management
  • Courage to lead and make tough decisions/strong influencing skills
  • Logical and independent thinking
  • Demonstrated high learning agility
  • Managing and delivering execution across multiple disciplines
  • Problem solver, innovative, creative with operational delivery solutions
  • Ability to coach and mentor others
  • Good judgment and personal flexibility to adapt to changes in R&D priorities
  • As a PTM (typically covering ≥3 compounds), represent non-clinical safety and potentially disposition (DMPK) on Project teams
23

Senior Forensic Toxicologist Resume Examples & Samples

  • Supervise analytical chemists that perform routine drug testing analyses
  • Provide day-to-day guidance and oversight for specimen accessioning/storage, drug screening/drug confirmation analyses, and data review
  • Assure that quality standards are followed and that all analyses are performed in accordance with laboratory SOPs and DoD drug testing policies
  • Certify laboratory results
  • Oversee method development, method validation and troubleshoot analytical challenges
  • Perform or delegate instrument maintenance
  • Assist with the development and implementation of a Laboratory Inventory Management System (LIMS)
  • Prepare monthly reports for leadership
  • Serve as a subject matter expert and an expert witness for military litigation proceedings
  • Perform or delegate immunoassay analyses, colorimetric analyses , spectrophotometric analyses in addition to solid phase and liquid /liquid extractions
  • Utilize Gas Chromatography/Mass Spectrometry, Liquid Chromatography/Mass Spectrometry, and Tandem Mass Spectrometry
  • Produce detailed notes and reports
  • Perform technical and administrative reviews of other analysts’ casework
  • Interact and collaborate with other group/team members and other forensic staff to ensure a high quality and accurate product
  • A minimum of a Bachelor of Science degree from an accredited college or university in the Physical Sciences (e.g., Chemistry, Pharmacology, Toxicology) coupled with 5+ years experience working in an accredited Forensic Toxicology laboratory; OR a Master of Science degree in the Physical Sciences (e.g., Chemistry, Pharmacology, Toxicology) coupled with 3+ years experience working in an accredited Forensic Toxicology laboratory
  • Proficient in Forensic Toxicology with advanced skills in solid phase and liquid/liquid extractions, immunoassays, Gas Chromatography/Mass Spectrometry and other chemistry analytical methodologies such as Liquid Chromatography Tandem Mass Spectrometry
  • Experience with toxicological casework involving postmortem, human performance, DUI/DUID, drug facilitated sexual assault investigations, and DoD drug demand reduction urinalysis toxicology
  • Laboratory supervisory / personnel management experience
  • Proficient working with Microsoft Office Suites, to include excel spreadsheets
  • Skilled communicator who can clearly articulate/communicate via email, telephone calls and video teleconferencing
  • Ability to obtain and maintain a DoD Secret clearance
  • Forensic Toxicology expert witness testimony
  • First authorship of scientific research in peer reviewed journal and/or presentation of scientific data
  • American Board of Forensic Toxicology (ABFT) certification
  • Knowledge and experience with method and instrument validations
  • Active in the field of Forensic Toxicology (e.g., Society of Forensic Toxicology member)
  • Familiar with database structure and/or a willingness to learn the necessary skills to configure and modify the Laboratory Inventory Management System (LIMS)
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Project Toxicologist Resume Examples & Samples

  • BS degree in a relevant scientific discipline including aspects of Toxicology/Safety Assessment
  • Minimum 3 years of relevant experience
  • Experience as a project team member covering a number of projects across a broad range of stages in development
  • Safety Assessment capability and experience coupled with an understanding of the interrelationships between disposition, safety and on/off target engagement as applied to the identification and articulation of critical needs and deliverables for projects
  • Knowledge and experience of the Safety Assessment aspects of worldwide regulatory requirements for drug development and registration
  • Broad knowledge / experience of drug disposition (ADME) an advantage
  • MS or PhD in a relevant scientific discipline
  • Diplomate, American Board of Toxicology or equivalent experience
  • Ability to work collaboratively in a highly matrixed, global organization
  • Demonstrated effective interpersonal, communication (written and verbal) and negotiation skills for a wide variety of audiences, including senior management
  • Demonstrated logical, independent thinking with strong influencing skills and courage to lead and to make tough decisions
  • Demonstrated high learning agility and ability to effectively manage multiple projects
  • Demonstrated problem solver, innovative and creative to provide operational delivery and scientific issue solutions
  • Good judgment and personal flexibility to adapt to changes in R&D priorities
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Principal Toxicologist / Director Resume Examples & Samples

  • Development of appropriate strategies to assess nonclinical safety of MedImmune assets; this includes high level input into designing studies and actively contributing to inclusion of pharmacodynamic readouts in these studies
  • Organising, planning and data monitoring of in vivo toxicology studies in collaboration with Associate Toxicologists and Toxicologists
  • Oversee the delivery of reviewed and approved final toxicology study reports, suitable for regulatory submission, in collaboration with Associate Toxicologists and Toxicologists
  • Contribute to regulatory documents (CTAs, IMPDs, INDs, BLAs, etc); be involved in interactions with regulatory authorities as needed
  • Communicate toxicology data internally and to Research Project and Product Development Teams, ensuring delivery in line with the business objectives of validity, integrity, quality, timing & cost
  • Attend and/or present at relevant governance committees, including but not limited to Research Review Committees (RRC), the MedImmune Safety Review Board (MSRB), and the Early and Late Stage Product Committees (ESPC, LSPC)
  • Identify threats to the nonclinical safety assessment plan, propose options for resolution or mitigation of these threats, and ensure implementation of appropriate adjustments to the nonclinical safety strategy
  • Act as a key functional expert in the field of nonclinical safety testing of biologics and maintain immunological and toxicological expertise; this includes, but is not restricted to, keeping up todate with the scientific literature, attend and contribute to relevant international meetings, and publish in peer reviewed journals
  • PhD degree in a relevant subject area
  • Extensive experience with managing CRO-based toxicology studies, including experience with studies in common toxicology species (rats and especially nonhuman primates)
  • Proven pharmaceutical industry experience in the field of nonclinical safety testing of biologics
  • Understanding of the regulatory requirements for the toxicology testing of biologics
  • Understanding of toxicological mechanisms as the basis of developing safe medicines
  • Experience with acting as nonclinical safety representative in early stage (lead optimisation-IND-Phase I) as well as later stage project teams (Phase II and beyond) Experience with preparing and submitting regulatory documentation (CTA/IND, briefing documents) and regulatory interactions
  • Other relevant professional qualifications or recognition, e.g. DABT/ERT
  • Specialist expertise in a field relevant to nonclinical safety testing of biologics, e.g. immunology/immunotoxicology
  • Recognised as an industry leader in the field of biologics safety testing as evidenced by publication record and involvement in professional organisation
  • LI-MEDI
26

Environmental Toxicologist / Entomologist Resume Examples & Samples

  • Designing, coordinating, and initiating testing program to characterize activity spectrum, non-target organism effects and ecological risk of new products
  • Preparing and reviewing ecological risk assessment reports to support registration of biotechnology-derived products
  • Keeping abreast of scientific and political developments relevant to U.S., OECD, and global regulatory guidelines for environmental safety assessments of plant incorporated protectants
  • Addressing agency and academic questions around ecotoxicology and ecological risk assessment of products with sound and supported scientific responses
  • Driving publications in accordance with product strategy
  • Representing Monsanto’s support for science based environmental risk assessment internally and externally with industry, academia, government and public stakeholders
  • Driving and leading new considerations/tools for NTO bioassays and ecological risk assessment on case by case basis--e.g. new modes of action
  • Minimum of Ph.D. in Ecotoxicology or a closely related discipline
  • Minimum of three or more years of professional experience monitoring and conducting GLP ecotoxicology studies and conducting ecological risk assessments for crop protection products
  • Functional knowledge of biostatistics, experimental design, exposure assessment, and analytical methodology
  • Strong project and time management abilities
  • Agility to work on multiple projects and flexibility to meet business objectives
  • Self-motivated and capable of functioning as an independent scientist while being able to work effectively in a team environment
  • Knowledge and/or experience interacting with regulatory authorities and issue management
  • Direct experience participating in industry task forces and/or work groups
  • Experience with U.S. and/or EU ecotoxicology test guidelines and risk assessment approaches for crop protection products including endangered species risk assessment
  • Prior experience leading scientific initiatives across functional areas
  • Prior experience working for a global company
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Medical Toxicologist Resume Examples & Samples

  • Provide advice and consultation to physician callers or poison center specialists on cases involving severe symptoms, and medical management questions
  • Provide phone or in person information when possible and/or needed
  • Other duties and responsibilities include teaching and research
  • Recent publications in the field of toxicology
  • Emergency medicine experience
  • Fellowship in Toxinology (specific to Envenomations)
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Clinical Toxicologist Resume Examples & Samples

  • Provide advice and consultation to physician callers or poison control center specialists on cases involving severe symptoms, and medical management questions
  • Provide other related information by phone or in person when possible and/or needed
  • There may be other teaching and research duties assigned as necessary related to this position
  • Completion of an accredited Toxicology Fellowship
  • Medical Toxicology Board certified or board eligible
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Quantitative Systems Toxicologist Resume Examples & Samples

  • PhD in Pharmacology, Toxicology, Biochemistry, Mathematics, Engineering, Physics or related disciplines with experience of applying mechanism based mathematical modeling techniques to biological systems. e.g. complex modeling approaches such as descriptive and predictive logic based models, PBPK models or mechanistic modeling in the pharmaceutical industry
  • Experience working in a computational toxicology/biology environment
  • Experience with quantitative systems modeling to design and develop new molecules with decreased safety liability
  • Experience of Scientific computing and programming e.g. experience in MATLAB + SimBiology and/or object oriented programming, together with one or more of the following (a) integration of discovery chemistry, extracting and analyzing decision-making data associated with chemical entities; (b) computational systems biology and toxicology and ability to integrate information at various levels of biological organization (molecular, cellular, organ, animal, population) using the Adverse Outcome Pathway framework; (c) and knowledge of semantic data mining and integration strategies (e.g. ontology’s, text analytics, database and tool interface development, computational chemistry)
  • Forward thinking, with evidence of scientific curiosity coupled with strong critical thinking, troubleshooting and problem solving skills in systems modeling in drug discovery and development
  • Demonstrated ability to work in multi-disciplinary teams with excellent interpersonal skills, particularly with regard to building strong working relationships within the computational community and external partners or customers
  • Excellent written and oral communication skills and the ability to interact effectively with scientists in other disciplines with a positive, collegial, and collaborative attitude
  • Knowledge of principles driving chemical reactivity and biological processes along with strong analytical skills resulting in demonstrable impact in a pharmaceutical/biotechnological environment
  • Evidence of commitment to developing self and others
  • Ability to prioritize amongst competing time demands
  • Demonstrated skills to programmatically collect, combine, mine and analyze complex biological and chemical data
  • Experience analyzing ‘omics data and building network models from data
  • Successfully leads in a matrix environment, working across functions/disciplines
  • Manages the planning and execution of projects until completion
  • Entrepreneurial mindset
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PHD Eco Toxicologist Resume Examples & Samples

  • Ph.D. in Eco-toxicology, Toxicology, Ecology, or Environmental Science with 3+ years experience in Environmental Risk Assessments; regulatory and research studies; and product safety/ compliance for agrichemicals, herbicides, pesticides, fertilizers, etc
  • Background in genetics and/or molecular biology is desirable
  • Experience working in a team-oriented environment managing multiple projects, possess excellent analytical, interpretive and communication skills, and be able to adapt technical skills to changing needs
  • A strong capacity for problem solving, planning, organization, and the ability to develop technical skills in disciplines beyond the candidate’s area of expertise
  • Strong written and verbal communication skills are essential for this position. A high level of advocacy skills and an ability to work with senior scientists
  • Travel- 15%
  • Only applicants authorized to legally work in the US without sponsorship can be considered
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Staff Toxicologist Resume Examples & Samples

  • Integrate with multiple functions across Boeing, including engineering, supplier management, Legal, government affairs, internal governance, etc
  • Guides and develops the technical foundations of policies, procedures and initiatives to ensure development of consistent processes
  • Represent the company with government agencies, suppliers, customers and industry and trade groups
  • Support regulatory compliance strategy for imports/exports and bans on chemicals present in our products or used in our manufacturing processes
  • Be able to effectively analyze complex information and communicate results to all levels within the company
  • Candidates must possess strong leadership, teaming, communication, project leadership, and computing skills
  • More than one year of toxicology experience is highly desired
  • Experience with aerospace operations and services is highly desired
  • An advanced degree in toxicology (or related field) is highly desired
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Environmental Toxicologist Resume Examples & Samples

  • Collaborates with multidisciplinary teams to assess and communicate environmental risks, perform environmental impact and fate & effects studies, address environmental issues during oil spill response, and identify and provide environmentally beneficial and cost-effective solutions to environmental issues
  • Typical activities include environmental risk assessment of operations, summary and critical analysis of literature data and regulations, creation and oversight of research programs, and participation in professional organizations and trade associations
  • Master’s degree in ecotoxicology/environmental toxicology or related environmental science discipline with 5+ years of petroleum industry experience OR Ph.D. in ecotoxicology/environmental toxicology or related environmental science discipline with 3 years of some petroleum industry experience
  • Broad training in environmental chemistry, fate and exposure assessment, and or ecotoxicology
  • Demonstrated ability to support Chevron’s Upstream and or Downstream Business Units in applying ecological risk assessment to address issues like discharges to water, ecological exposures and ecosystem health
  • Experience or ability to support Chevron’s Environmental Management Company project managers in applying ecological risk assessment to address remediation of impacted sites
  • Experience in lab and field methods used in environmental assessment is a plus, as are strong quantitative skills
  • Drive to create and actively implement new areas of work that intersect technical abilities and value to Chevron. Interest and ability to identify and implement science and technology R and D to provide innovative, cost-effective solutions to manage environmental risk
  • Excellent oral and written communication skills, including strong ability to communicate the business implications of environmental risks clearly, concisely and effectively
  • Demonstrated ability to negotiate with regulators on scientific merits of various approaches/interpretations
  • Ability to facilitate discussions and build collaborative relationships with diverse and multi-cultural audiences including ETC colleagues; business unit HES specialists and managers; external consultants; regulators; and other stakeholders
  • Skilled in managing the delivery of high quality, value-added technical HES consulting services that meet customer expectations within agreed budget and schedule including for international customers in different time zones
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Staff Toxicologist Resume Examples & Samples

  • Write toxicological risk assessment and biological evaluation reports
  • Collaborates with sites to investigate and troubleshoot issues concerning biological safety
  • Collaborates with sites to align processes, implement best practices, develop metrics and trending data to provide, both site and corporate management timely updates on product quality
  • Apply toxicological principles to address complex regulatory requirements for product submissions
  • Monitor regulatory trends, assess business impact to existing and future product lines relating to biocompatibility
  • Maintain high level of toxicological expertise by identifying and critically assessing emerging theories and methodologies and applying gained expertise to meet research objectives that align with strategic objectives
  • Knowledge of orthopedic / pharmaceutical industry desired
  • Demonstrated expertise to effectively communicate within all levels of the organization around concepts of design control, design verification and validation activities; ethylene oxide, irradiation, steam/moist heat and aseptic processing; sterile packaging validation; biocompatibility; production and process controls; cleanroom management and control; Corrective and Preventive Action (CAPA), complaints and risk management; and product quality improvement
  • Competency in using computer software such as Excel, Word and PowerPoint
  • Must be willing to travel (approximately 20%)
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Associate Toxicologist Resume Examples & Samples

  • Support existing products and development of new products contributing to safety assessments and regulatory submissions (NDIs, GRAS, FAP, etc
  • Help to manage contract laboratories conducting nonclinical toxicology studies by designing, reviewing, and finalizing study protocols and reports. You will report to the Principal Scientist of Toxicology & Kinetics
  • Prepare early safety assessments by literature/databases searches and using in silico tools (predictive QSAR models)
  • Identify safety profile of candidate compounds / chemical impurities in defined cases
  • Determine toxicological studies that are required to support regulatory clearances of products and manage the placement and conduct of those studies with contract laboratories
  • Contribute to experimental design and planning of nonclinical toxicology studies
  • Ensure compliance of studies in accordance with relevant guidelines and regulation (e.g. OECD/GLP guidelines and applicable FDA regulations)
  • Monitor studies conducted by CROs, review and finalize study protocols and reports
  • Analyze data and interpret results with input from senior staff on occasion
  • Summarize studies reports to be part of regulatory submissions (NDIs, GRAS, FAP, etc.)
  • Review current scientific literature on an ongoing basis
  • Present research findings to internal stakeholders
  • BS with 3-5 years’ experience or MS with 1-2 years of experience in toxicology, pharmacology or in a health or environmental sciences with a major emphasis in toxicology
  • General toxicology knowledge and expertise in conducting risk assessments
  • Experience w/ design and planning of nonclinical toxicology studies
  • Strong technical writing and oral communication skills, as well as excellent organizational skills are essential
  • Excellent computer skills, including knowledge of most common IT programs as Microsoft Office 2007 (2010)
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Toxics Reduction Toxicologist Resume Examples & Samples

  • Work experience within the fields of green chemistry and/or safer chemical alternative selection is highly preferred
  • A Ph.D. or Masters of Science degree with a focus on green chemistry and safer chemical alternative selection is highly preferred
  • Has completed a certificate program in green chemistry and/or safer chemical alternatives (Please see the University of Washington's Green Chemistry & Chemical Stewardship Certificate Program as an example)
  • Knowledge of industrial processes involving hazardous substances, generation of hazardous or solid wastes, air emissions and wastewater discharges to analyze the technical feasibility of alternative chemicals and reduce hazardous material use at industrial scale
  • Ability to present technical information (written and through presentation) with clarity to a wide audience
  • Ability to interact with a wide variety of individuals and exercise communication skills needed to network within Industrial and Toxics Reduction communities
  • A cover letter describing how your experience, skills and abilities meet the required qualifications of this position
  • A resume outlining your professional experience