Here are sample job postings for Toxicologist roles...

Toxicologist

Center For Toxicology and Environmental Health LLC

Little Rock, AR

A Toxicologist at CTEH provides support in the areas of toxicology, risk assessment, industrial hygiene, and emergency response and may participate as a member of an emergency response team responding to chemical release emergencies. A Toxicologist will assemble, prepare, and analyze data concerning toxicological, environmental, and human health risk assessments and provide support to Project, Senior, and Principal Toxicologists as well as CTEH project managers. Utilizing his/her knowledge of various scientific disciplines, he/she may conduct and/or supervise sampling, monitoring, and information collection. Position location is at CTEH’s main branch office in North Little Rock, AR. This is a career track opportunity starting at an entry level toxicologist with advancement to senior levels, commensurate with experience and education.

Vaccination against Covid-19 is strongly preferred. All employees will be subject to policies and procedures of the Company that may be dependent on vaccination status.

BENEFITS

• Health Insurance with PPO/HDP options

• Dental Insurance

• Vision Insurance

• Flexible Spending Account (with PPO)

• Health Savings Account (with HDP)

• Life Insurance/AD&D Insurance

• Short- & Long-Term Disability

• 401-K Retirement Savings Plan

• Short Term Incentive Pay

• Annual Incentive Compensation Plan

• Paid Time Off

• Paid Holidays

• Paid Sick Leave

• Paid Parental Leave

• Professional Development Assistance

• Employee Assistance Program

SCOPE OF WORK

• Availability for sudden and extended travel as a member of an emergency response team to chemical and/or natural disasters at clients’ requests to oversee/conduct air, water, and/or soil sampling, meteorological monitoring, and other scientific data collection;
• Provide data management and evaluation support to project managers in the areas of toxicology, risk assessment, industrial hygiene and emergency response;
• Participate in business development activities as assigned, including assisting in the development of articles and presentations;
• Evaluate project needs in the areas of toxicology, risk assessment, industrial hygiene, and emergency response and develop strategies to address issues related to each project;
• Prepare written reports summarizing scientific data and findings;
• Perform risk calculations and prepare risk assessment and toxicology summary reports;
• Compile, critically review and summarize scientific/technical data and literature;
• Act as a point of contact for clients of the company including taking calls related to CTEH’s worker exposure response program;
• Obtain appropriate training and experience in order to develop the skills necessary to serve as a project manager/director; and,
• Perform such other duties as assigned.

EDUCATION/EXPERIENCE

• Doctorate degree in Toxicology with 0 to 2 years of related post-degree work experience; and,
• Skilled with data management and word processing software including advanced computer skills in a Windows-based platform

Biocompatibility SME / Toxicologist (Remote)

BAXTER

Deerfield, IL 60015

At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You’ll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients.

Baxter’s products and therapies are found in almost every hospital worldwide, in clinics and in the home. For over 85 years, we have pioneered significant medical innovations that transform healthcare.

Together, we create a place where we are happy, successful and inspire each other. This is where you can do your best work.

Join us at the intersection of saving and sustaining lives— where your purpose accelerates our mission.

#This is where you have a direct impact on patient safety

The Biocompatibility SME / Toxicologist will support a diverse portfolio of medical devices for global registrations. In this role you will apply a proven understanding of medical devices and device packaging toxicology requirements to support safety evaluations and preclinical regulatory submission content development. Other responsibilities include design biological risk assessments/strategies for evaluating medical devices, monitor testing and interpret the results for project teams.

Your Team at Baxter

Within Quality, every role makes a difference. Products that Baxter makes are shipped worldwide for patients in need. Whether it's building a new process from scratch or facing a never-before-seen production hurdle, individuals within Quality are given the trust and opportunity to bring creativity to the table. Regardless of your specific role with a product, it is sure to touch a portion of our global operation.

The mission of Baxter is to save and sustain lives. This mission is embedded into everything we do. This means if there is a decision to be made where quantity and quality are at odds, we will always choose quality. Our patients come first, always.

The Quality function values both working together as a team and independently. We draw energy from working in a plant or an office where there are opportunities to collaborate. As the company evolves, so does the way our team approaches work as it strives to create top-of-the-line products.

We build relationships with each other to get work done. Building these relationships is easy because we all share common traits of being reliable, ethical, and caring. We lean on our colleagues for their expertise and hold each other accountable. We feel empowered to speak up when there's a new insight or opportunity to improve something. This open dialog builds trust within the team and helps create a better product for our customers.

What you'll be doing

• Develop testing strategies such as the biological evaluation plan to qualify medical devices according to global guidelines.
• Lead projects and coordinate safety testing for Baxter’s product portfolio. Review literature and identify relevant articles to support product development and registration.
• Interpret data and develop justifications to address safety in alignment with ISO 10993-1 Develop preclinical regulatory submission content for DMF files, USA FDA 510 K Submission, EU MDR and global submissions.
• Address potential inquiries related to safety assessments (biocompatibility / toxicology risk assessments) submitted to FDA, EU notified bodies or global ministries of health.
• Implement the use of ISO 10993 series, regional pharmacopeia, 21 CFR Part 58 Good Laboratory Practices for Non-Clinical Studies, and/or regulatory guidance documents to qualify Baxter products.
• Perform preclinical change control impact assessments and work with cross functional team members (engineering, extractables and leachables, regulatory, etc.) to determine a comprehensive testing strategy.
• Mentor junior team members and review test strategies.
  

What you'll bring

• Bachelor's degree in a scientific field with 15 years of relevant experience.
• MS with at least 10 years experience, or PhD with at least 3-4 years of relevant experienced required.
• Lab experience includes research in GLP/GMP environment, leadership of technical teams, and project management experience is desirable.
• Relevant technical knowledge in biocompatibility/toxicology and general understanding of material physical and chemical properties.
• Ability to understand and apply global regulatory guidelines including OECD, FDA GLP, ISO 10993 series, USP pharmacopeia and regional compendia.
• Experience in working in global cross-functional teams and study monitoring.
• Critical thinker with intellectual self-assurance and courage.
• Independent problem solver who can use a methodical approach to develop solutions and make recommendations.
• Ability to contribute to efforts beyond own scope of responsibilities to ensure project achievements are met.
• Optimally connect with internal and external partners.
• Good oral and written communication in English. Multilingual desired for communication with global teams highly desired but not required (i.e. Spanish, French, Italian, German). Excellent attention to detail.
• Software knowledge of Siemens Teamcenter Unified, Microsoft Office, Trackwise, and Documentum based systems, recommended.
• DABT or eligible highly desired.

Toxicologist

Momentive

Niskayuna, NY•Hybrid remote

Position Summary:This highly visible position is responsible for toxicology support for multiple Business Segments and is responsible for planning and monitoring toxicology testing programs, conducting product safety assessments, and supporting product regulatory compliance globally. This position will strategically support advocacy efforts by representing the company on industry consortia and contributing ideas and aiding in the design and conducting of toxicological studies.

Responsibilities:

• Plan, coordinate, and monitor mammalian and environmental toxicology studies including budget, timing, and compliance deadlines.
• Formulate testing strategies and work plans, review study protocols, monitor studies, interpret testing results and utilize results in product safety assessments.
• Serve as a Momentive expert in hazard assessment, and risk assessment activities.
• Ensure that testing meets all international & domestic test requirements according to ISO, GLP, EU REACH, US EPA/FDA, Japan guidelines, and potentially other world areas.
• Represent Momentive in silicone and chemical industry association and REACH consortia technical groups: Global Silicones Council (GSC) and Silicones Environmental, Health, and Safety Center (SEHSC), Centre Européen des Silicones (CES) and ReconSile.
• Interpret regulatory requirements and leads discussions with the Businesses and Technology to formulate product testing strategies for new and existing products. Must be able to effectively communicate complex information to a variety of internal and external audiences.
• Actively leads, participates, and supports Product and Application Risk Reviews to inform the Businesses and implements Product Stewardship standards to comply with company requirements.
• Partner with global customers, suppliers, Businesses, and other functions to develop and communicate product regulatory and compliance solutions; provide training and education; and answer customer inquiries.
• Support new substance notification, registration, and related activities by working closely with members of the global Product Stewards Organization. Includes preparing documentation for product registrations and reporting for regulatory agencies in various world areas, monitoring, and providing status reports on relevant testing.
• Monitor legislative and regulatory changes in various world regions, contribute to advocacy efforts, initiate necessary communications and actions related to changing global chemical regulations, and implement solutions to address these changes.
• Maintain and compile toxicology related registration information in the relevant registration IT tools, e.g. IUCLID, and internal data repositories.
• Conduct Exposure and Risk Assessment models such as EasyTRA, ECETOC, CHESAR and ChemSTEER
• Establish, manage, and report metrics for work and tie into global reporting to assure progress and accomplishment of work are communicated.

Key Metrics:

• Completion of toxicology strategy and related tasks in support of product registration/notification, business growth, compliance and consortia activities within deadlines and interim milestones.
• Advise on human health and environmental risks as part of Risk Reviews.
• Development and implementation of streamlined processes and operating procedures to ensure compliance, timely response, and appropriate documentation.
• Timely and accurate responses to customer inquiries, leveraging standard templates and responses, and maintaining necessary data.
• Monitor changes in relevant regulations, and provide proactive communication and strategic guidance to global team members, Businesses, Technology, and other functions

Regulatory Toxicologist

The Hershey Company

(part of Hershey Trust Company)

Hershey, PA•Hybrid remote

Seeking a regulatory toxicologist in our Regulatory Center of Excellence in Hershey, PA who enjoys evaluating chemical safety, problem solving, and tackling complex issues. In this role, you will support The Hershey Company’s regulatory compliance strategy and provide subject matter expertise on regulatory and safety related topics. You will conduct risk assessments and collaborate with, and provide technical advice to, a variety of functions, including R&D/product development, packaging, marketing, legal, communications, and manufacturing partners. This role will involve interacting with trade associations and regulators/government agencies and monitoring global regulatory impacts relevant to The Hershey Company’s portfolio. You will be part of a dynamic team ensuring the safety and regulatory compliance of Hershey’s products.

Role Responsibilities:

50% - Regulatory Compliance and Safety Support:

• Provide regulatory leadership for global topics and strategic approaches to assist regional regulatory subject matter experts and ensure compliance. Utilize internal and external tools and systems to evaluate ingredients and formulas to make proactive risk-based decisions
• Evaluate safety data for ingredients/packaging chemicals and conduct risk assessments to ensure food chemical safety and regulatory compliance.
• Support the development of specifications for chemicals in food and oversee internal chemical management programs for key ingredients to support the business while ensuring regulatory compliance.

40% - Business Engagement/Technical Leadership:

• Effectively communicate scientific information to nontechnical partners and provide safety and regulatory advice to cross functional colleagues (e.g., product development and marketing partners).
• Lead regulatory projects of medium to high complexity with minimal supervision. Develop regulatory standards, SOPs, programs, processes, and tools; and communicate regulatory policy to regional regulatory partners and other internal stakeholders.
• Monitor relevant regulatory actions and proposals from government agencies along with emerging topics and be able to highlight key impacts to the portfolio and potential options to address and ensure continued compliance.

10% - Other Regulatory Compliance Responsibilities:

• Conduct risk assessments and provide technical expertise to support the manufacturing facilities in incident management. Provide support and assistance to the analytical laboratory.
• Participate in trade associations and external working groups and provide input on relevant topics.
• Support Consumer Relations, Corporate Communications, and Sales by providing responses and external communication resources for questions related to safety and regulatory compliance

Qualifications:

• Education: Advanced degree preferred. Bachelor’s degree in science related field (Toxicology, Pharmacology, Chemistry, Food Science or comparable) with experience will also be considered.
• Experience: Experience preferred, but recent graduates with a PhD or Master’s degree are welcome to apply. B.S. with minimum 3 years of Regulatory Affairs/Toxicology experience
• Conducting literature reviews and summarizing toxicology testing data and complex scientific information
• Experience conducting human health risk assessments
• Understanding of global regulations and the use of adopted guidance documents and frameworks to support risk assessment and regulatory compliance
• Computational background/skills and/or proficiency in a programming language is a plus
• Excellent verbal and written communication skills
• Attention to detail and strong problem solving and critical thinking skills
• Excellent organizational skills and ability to prioritize work with overlapping deadlines
• Strong initiative, willingness to learn, and the ability to adapt in a fast-paced environment
• Ability to influence and make complicated subjects clear and presentable
• Must be able to work both independently and cooperatively in cross functional teams
• Impeccable ethics and must maintain a high level of confidentiality