Toxicologist job description

Gradient, an environmental consulting firm, is seeking a high energy individual to assist colleagues and clients in toxicological risk assessments and biological safety evaluations for medical devices.

Excellent benefits, friendly, hybrid work environment with locations in Boston, MA; Seattle, WA and Charlottesville, VA.
Applicants should possess the following:
Willingness to learn Biological Safety regulations (ISO 10993 and ISO 18562) and geography-specific requirements for both the USA and European Union to support regulatory submissions. Review and analyze technical data from multiple sources to assess potential toxicological risks and compliance to current regulations. Ability to conduct strategic biological safety evaluation programs for medical devices that include: hazard identification, literature reviews, use of new and existing biological safety data, design of chemical characterization studies for extractables and leachables, and toxicological risk assessments. Ability to coordinate with external labs to communicate test methods, sample submission, and review of test lab reports. Experienced in medical device material selection and manufacturing processes to evaluate patient/product safety is a plus.



Position requires at least an M.S. in toxicology or related field. Candidates must have excellent writing and quantitative skills, and the ability to work independently in a challenging and fast-paced work environment. Prior consulting or industry experience in medical device field, including managing projects with multiple staff is a plus. Strong data management experience is a plus.



Benefits:
Our benefits are comprehensive and include:
Medical and dental insurance
Disability insurance (short- and long-term)
Life insurance
Retirement savings
Paid time off (holidays, vacation, and sick leave)
Tuition reimbursement
Professional development allowances
Company-wide bonus program
Company-paid public transportation options
Professional registration fee reimbursement
Company events
Gradient provides employees with the right tools to meet challenges and to excel and grow both personally and professionally.

Remote
90-103/hr.
Plays a pivotal role in characterizing the environmental and occupational attributes of Pfizer’s product portfolio. This is a foundational building block in initiation of risk assessment to enable effective decision making related to worker and environmental protection aligned with Purpose Breakthroughs that change patients’ lives. The role affords an unparalleled opportunity for the candidate to shape the future direction of key EHS programs using intelligence gained from evaluating emerging areas of R&D and business interest. Holds responsibility for the hazard characterization and communication program, evolving it as necessary to meet the needs of the company’s biopharmaceutical portfolio. In scope includes timely development and timely communication of Environmental Interest Levels (EILs) and Predicted No-Effect Concentrations (PNECs) to facilitate environmental protection, Occupational Exposure Values (OEVs) to support worker safety programs and Product Classifications and Acceptable Daily Exposure (ADE) values to ensure product/patient safety. Establishes and maintains effective partnerships with business leaders to ensure program priorities remain aligned with business developments; building program strategies to address emergent modalities as needed. Establishes and maintains effective relationships with EHS and operational teams contributing to the development of effective risk assessments and implementation of contemporary control practices.
Toxicologist Responsibilities

• With oversight of the Occupational Toxicology and R&D EHS Lead develops and maintains the operational standards, practices and methodologies applied by the Technical Review Committee (TRC) and Environmental Technical Review Committee (eTRC); innovating as necessary to address emerging modalities and improve operational efficiency
• Drives TRC and eTRC work plans, aligned with pipeline priorities equipping team members with preparatory information to enable decision making
• Evaluates the potential hazards of Pfizer programs (including proprietary substances) to worker safety, product/patient safety, and the environment; on the basis of study reports and guided by published scientific information and industry benchmark data
• Authors / oversees development of work products (e.g., PNEC, OEL, and ADE value monographs), providing traceability to data sources used in the decision-making process. Interfaces with Safety Data Sheet (SDS) authors to ensure timely and accurate development / updates
• Leads periodic reviews to assess program effectiveness, e.g., through stakeholder surveys and data accuracy sampling within key Digital systems (e.g., Compound Profile)
• Oversees worker and environmental safety testing programs at external toxicology labs to augment available non-clinical and clinical data relevant to hazard characterization for new product introduction and to support chemical registration data requirements (e.g., European Union (EU) Registration, Evaluation, and Authorization of Chemicals (REACH))
• Maintains active and productive engagement with industry forums, Research & Development lines (small / large molecule, vaccines), and New Product Development and Business
• Development teams to determine trends in emergent modalities, future business direction, and priorities for hazard characterization program development; uses the intelligence gathered to build operational practices, further increasing the robustness of the hazard communication programs
• Establishes and maintains processes to enable effective communication and education of key stakeholders on the hazard classifications and expected actions; develops briefing and training materials
• Partners with EHS and operational teams to develop risk assessments, leading to the selection and implementation of contemporary control practices
• Engages Global EHS program leads and partner lines (e.g., engineering, operations) to facilitate further development of technical programs to address novel modalities; thereby ensuring appropriate risk mitigation strategies/controls are established ahead of new product introduction
• Contributes to Occupational Risk Evaluations for EHS topics aligned with technical skillsets and competencies

Toxicologist Qualifications

• Project planning, tracking and management skills to ensure actions and commitments are delivered to plan
• Excellent oral, written and interpersonal communications skills and the ability to work across multiple countries and cultures
• Ability to develop conclusions on available scientific data that may be incomplete; and apply that to assess EHS risks and business implications in order to secure stakeholder commitment to action
• Environmental / occupational toxicology program experience; including leading complex risk assessment, and hazard communication program development
• Graduate degree in Toxicology (ideally with an occupational and environmental focus
• Board Certification in Toxicology (e.g., American Board of Toxicology (ABT) or Academy of Toxicological Sciences (ATS)); with maintenance of the formal continuous professional development requirement
• Occupational Hygiene / Biosafety / Environmental or related program experience
• Track record of leading cross functional and virtual teams in complex environments.
• Experience working in dynamic complex, matrixed business models.

Title: Toxicologist I

Department: Toxicological Services

Job Type: Regular Full Time

Schedule: Tuesday through Saturday 8:00am to 4:30pm

Company Summary:

NMS Labs has developed an extensive menu of more than 2,500 tests to support clients in forensic, criminalistic, public health and clinical fields. For over 50 years, our clients have relied on NMS Labs for unique testing solutions that demonstrate our company core values of Quality, Integrity, Service, Innovation and Engagement. As we work to increase the company's positive impact on public health and public safety, we are seeking talented professionals to join us for the journey! We invite you to learn more about our company by visiting NMSLabs.com.

NMS is seeking a Toxicologist I to work in their Toxicological Services Department at the Horsham, PA location. After the training period, the candidate may choose to work a hybrid (home/lab) schedule.

The Toxicologist I will perform the following:

* Performs final review of data, administrative information, and provided case history prior to release of reports to ensure report accuracy.
* Identifies potential laboratory-related issues and makes the appropriate notifications.
* Review litigation packets for acceptability.
* Responds to questions from Laboratory Operations, Expert and Client Support Services.
* Provides testimony.
* Other duties as assigned.

Knowledge, Skills, & Abilities:

* Working knowledge of analytical procedures including a basic understanding of analytical terminology, methods and theory, and methods of data interpretation.
* Working knowledge of pharmacology and toxicology including pharmacokinetics; pharmacodynamics; integration of case-related issues to proper analyses; interpretation of analytical results.
* Ability to testify in court about laboratory processes and explanation of analytical findings.
* Strong verbal and written communication skills.
* Ability to communicate and coordinate closely and effectively with toxicologists, client services personnel, laboratory staff, and clients (including physicians, lawyers, and client service reps from external organizations).
* Comprehend regulations and apply them to work-related tasks.
* Define and resolve problems, collect data, establish facts and draw valid conclusions.

Requirements:

* Master's degree + 2 yr. relevant experience with 1 yr. post-graduate experience OR
* Ph.D. degree + 1 yr. relevant experience
* ABFT board eligibility or certification is required
* Travel for courtroom testimony as needed
* Must have completion of at least 24 semester hours in chemistry including general chemistry, organic chemistry, and analytical chemistry (to include instrumentation), 1 interpretive science course (e.g., biochemistry, pharmacology, toxicology, etc.), 1 statistics course, and a graduate degree in a relevant scientific discipline

Physical Demands:

* Ability to talk, hear, stand, reach with hands and arms, and use hands and fingers to manipulate instrument/equipment controls, computer keyboard, office equipment, objects, or tools.
* Moving from one work location to another to sit and stand, sometimes for extended periods of time.
* Specific vision abilities (with correction) including color vision, distance vision, peripheral vision, depth perception, and the ability to adjust focus.
* Ability to travel as needed.

Offers of employment are made contingent upon a nationwide background investigation and urine drug screen with results satisfactory to standards of employment at NMS. NMS requires all employees to show proof of full COVID-19 vaccination.

We are an equal opportunity employer and will not discriminate against any employee or applicant for employment because of race, creed, sexual orientation, color, religion, sex, national origin, age, marital status, citizenship status, otherwise qualified disability, or protected veteran status (disabled Armed Forces Service medal, recently separated, active duty or campaign badge), domestic violence victim status, arrest record, or predisposing genetic characteristics.