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Job: Senior Toxicologist, General, knoellUSA, Home Office, NC

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General Information

Job title:
Senior Toxicologist, General
Job location:
Home Office, NC  99999 United States
Requisition code:
Date posted:
Job category:
Regulatory Affairs
Employment type:
Full time

Job Description

Company Background
knoell is a global company with headquarters in Germany that researches, processes and evaluates scientific data across all scientific specialties. Our vision is to be the trusted industry leader in worldwide regulatory solutions. We compile registration dossiers and submit them to national and international authorities. The size of our company allows us to act as a full service provider and assemble a team of the required size and expertise to serve clients in agrochemical, biocides, food contact, industrial chemicals, product safety, veterinary medicine and medical devices. With 20 locations in 14 countries, we are able to serve our clients needs with a global team of >400 experts.

knoell USA is part of an extensive network of scientific and regulatory experts who partner with major multi-national, mid-tier and start-up clients. Services include scientific consulting, analytical services, technical writing, and document management services with offices in Pennsylvania, North Carolina, and Tennessee.

The Senior Toxicologist is responsible for leading toxicology activities on client projects. The Senior Toxicologist will work as part of the global centralized toxicology team with opportunities to work in a variety of projects, including agriculture, chemicals, food contact, and/or medical devices.

Essential Functions
• Manage toxicology activities for client projects
• Complete safety assessments in one or more areas, such as agriculture, chemicals, food contact, consumer products, or medical devices
• Ability to conduct toxicological literature searches and literature reviews, summarizing scientific literature and study reports
• Experience with use of SAR Modeling (Structure Activity Relation) and read-across techniques
• Experience with use of databases such as ToxTree, LeadScope, ToxPlanet, etc.
• Participate in drafting regulatory reports, contributing to the safety assessment portion of these reports
• Preparation of the toxicology portion of global regulatory submissions
• Support the completion of Food Contact Notifications, including the Comprehensive Toxicology Profile and Safety Narrative.
• Author waiver submissions
• Review technical reports and finalize deliverables for client
• Manage projects from initial client contact stage to project completion, within the prescribed timeline
• Organizing project-related materials and files in line with confidentiality and security requirements
• Interact with clients in-person, via email or phone
• Engage directly with regulatory authorities
• Oversee project management activities, including status reports for client as needed
• Management experience in supervising direct reports & other toxicologists
• Oversee lab testing plans and subcontracting efforts
• Placement and Monitoring of Toxicology Studies
• Support business development/acquisition activities, including participation in conferences and other activities to promote the business
• Speaking at webinars and conferences in order to promote knoell services
• Participate in trade organizations such as Society of Toxicology (SOT), Personal Care Product Council (PCPC), etc.

Job Requirements

• Expertise in Regulatory Compliance (FDA, EPA, EU)
• MS or Ph.D. degree in toxicology, forensic science, chemistry, or a related discipline
• Post-doc or professional experience (7-10 years) in toxicology
• Experience in the following industries: food contact, chemical, agribusiness, consumer products, medical devices or pharmaceutical.
• Diplomat of the American Board of Toxicology (DABT) or related certification is preferred or willingness to become board certified.
• Experience with submission to the following regulating bodies: US Food and Drug Administration and/or EFSA or similar agencies internationally.
• Sound scientific principles, flexibility, and willingness to learn.
• Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization and the client’s organization if applicable.
• Strong organizational and follow-up skills, as well as attention to detail.
• Strong project management including ability to manage time versus budget.
• Excellent written and verbal skills, including authoring of proposals, assisting in drafting regulatory reports, and preparing of FDA submissions for no-objection letters.
• Must be self-motivated and effective with time management.
• Ability to work within a global matrixed team and collaborate on workflows and prioritization.
• Strong ability to prioritize multiple projects with competing deadlines.

knoell offers competitive compensation and benefits package, including medical, dental, vision, life, disability, 401(k) with company match, and tuition reimbursement.

We are an Equal Opportunity Employer and do not discriminate against applicants due to veteran status or on the basis of disability. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, or national origin.

knoell is a drug-free workplace. As a condition of employment, all new hires are required to pass a pre-employment drug test.
(Job number: 4048470)
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