Managing Toxicologist

Trinity Consultants - SafeBridge; United States; On-site; USD 120,000 - 160,000; Full time

Job summary

SafeBridge Consultants, Inc. is seeking a Consulting Toxicologist to join our team of experts in industrial hygiene, safety, toxicology, risk assessment, and analytical chemistry. You will gain on-the-job training to advance applied toxicology in a consulting setting.

You will evaluate chemical and biological risks, advise on exposure limits, hazard assessments, and regulatory compliance, and lead projects from scoping through delivery with client communications and budgeting oversight.

Qualifications

• Experience conducting hazard and quantitative risk assessments.
• Ability to evaluate animal, clinical and mechanistic data with weight of evidence considerations.
• Strong scientific writing supporting toxicology assessments and regulatory safety reports.
• Ability to explain conclusions clearly to clients and translate to risk management actions.
• Strong organizational skills to manage multiple projects and deadlines.

Responsibilities

• Prepare, review, and approve hazard and risk assessments for pharmaceutical/biotech compounds and materials.
• Develop occupational exposure limits, OHCs, PDEs/ADEs, and SDSs.
• Create product safety assessments to support cleaning validation and impurity assessment.
• Evaluate data quality and justify weight of evidence with transparent rationales.
• Provide clients with practical toxicology, risk, and regulatory-compliance advice.

Skills

Hazard and risk assessments

Critical evaluation of data

Scientific writing

Explain scientific conclusions

Project management

Education

PhD preferred in toxicology or related field

Master's degree with relevant experience

5+ years of toxicology experience

Job description

Please note: We are only considering W2 candidates at this time. Applications from third-party vendors or C2C arrangements will not be considered.

SUMMARY

SafeBridge Consultants, Inc., a trusted provider of high-level safety, health, and environmental consulting services to the pharmaceutical, chemical, biotechnology, and food/consumer products industries, is seeking a Consulting Toxicologist to join our growing team. This role offers an excellent opportunity to work alongside a senior team of recognized experts in industrial hygiene, safety, toxicology, risk assessment, and analytical chemistry. You will receive comprehensive on-the-job training to develop your skills and expertise in applied toxicology within a consulting environment. As a Consulting Toxicologist at SafeBridge, you will contribute to evaluating chemical and biological risks, advising clients on exposure limits, hazard assessments, and regulatory compliance, supporting toxicology-related aspects of workplace safety and environmental health programs.

DUTIES AND RESPONSIBILITIES:

• Prepare, critically review and approve high-quality toxicological hazard and risk assessments for pharmaceutical and biotechnology compounds, process intermediates, impurities, contaminants and other materials.
• Develop occupational toxicology documents, including occupational exposure limits (OELs), occupational health or hazard categorizations (OHCs), acceptable surface limits (ASLs) and safety data sheets (SDSs).
• Develop product safety assessments, including permitted or acceptable daily exposures (PDEs/ADEs), to support cleaning validation, cross-contamination control and the assessment of impurities and other contaminants.
• Evaluate the quality, relevance and limitations of toxicology data; select appropriate points of departure and adjustment factors; and document transparent, scientifically defensible rationales.
• Provide clients with practical toxicology, risk assessment, and regulatory-compliance advice relevant to pharmaceutical development and manufacturing.
• Lead projects from scoping through delivery, including defining the technical approach, managing budgets and schedules, and maintaining clear client communication.
• Support client relationships, proposals and appropriate business-development activities within the candidate's areas of expertise.
• Provide technical oversight, coaching and review to other consultants, supporting consistent scientific quality and professional development.
• Maintain current knowledge of relevant pharmaceutical guidance, toxicology methods and regulatory expectations.

REQUIRED SKILLS/ABILITIES:

• Demonstrated experience conducting hazard and quantitative risk assessments.
• Ability to critically evaluate animal, clinical and mechanistic data, including limited datasets, and to document the application of weight of evidence, read-across and uncertainty factors in a scientifically defensible manner.
• Strong scientific writing skills, evidenced by authorship of toxicological assessments, health-based exposure limits, regulatory safety assessments or comparable technical reports.
• Ability to explain and defend scientific conclusions clearly to clients and colleagues and to translate them into practical risk-management advice.
• Strong organizational and interpersonal skills, with the ability to manage multiple projects, priorities and deadlines.

Highly desirable

• Direct experience deriving OELs, OHCs, PDEs/ADEs or other health-based exposure limits for pharmaceuticals.
• Experience assessing highly potent active pharmaceutical ingredients, biologics, antibody-drug conjugates, novel modalities, impurities or extractables and leachables.
• Toxicology consulting experience, including project scoping, client management, technical review and mentoring.
• Professional toxicology certification, such as ERT or DABT, or clear eligibility and willingness to obtain an appropriate certification.
• Knowledge of relevant global pharmaceutical and workplace-safety guidance, including ICH, EMA, FDA, OSHA and USP expectations.

EDUCATION AND EXPERIENCE:

• An advanced degree in toxicology, pharmacology or a closely related discipline. A PhD is preferred; a relevant master's degree combined with strong directly applicable experience will also be considered.
• A minimum of five years of directly relevant professional toxicology experience after completion of the qualifying degree; eight to ten years is preferred.
• Substantial hands-on experience assessing pharmaceutical or biotechnology compounds. This may have been gained within the pharmaceutical industry, biotechnology, a CDMO/CRO or an occupational toxicology consultancy.

SUPERVISORY RESPONSIBILITIES:

This position does have supervisory responsibilities.

PHYSICAL REQUIREMENTS:

The physical requirements listed below represent the minimum standards that an employee must meet to perform the essential functions of this role successfully. Reasonable accommodations can be made to enable individuals with disabilities to perform these functions.

• Regularly required to sit, use hands, and communicate verbally.
• Occasionally required to stand, walk, and reach with hands and arms.
• Must occasionally lift and/or move up to 10 pounds.