Scientist – Toxicology

Scientist – Toxicology

Requirements

• Bachelors degree in life sciences or related field and 2+ years experience in CRO and/or pharmaceutical industry in the conduct of small molecule Toxicology/Safety Pharmacology programs.
• Experience in managing preclinical CROs.
• Experience in the conduct of in vitro or in vivo toxicology techniques to support investigative toxicology or pharmacokinetic activities, including dose preparation and dosing of animals.
• Experience with conduct of pharmacokinetic and metabolism studies is highly desirable.
• Experience with micro-sampling techniques is a plus OR MS/MA degree Toxicology or related field and some relevant experience preferred.
• Working knowledge of the conduct of in vitro or in vivo toxicology techniques to support investigative toxicology or pharmacokinetic activities, including dose preparation and dosing of animals; pharmacokinetic and metabolism studies and micro-sampling techniques.
• Effective report writing and oral presentations skills.
• Must be able to build excellent working relationships & maintain confidentiality regarding intellectual property and proprietary endeavors of the company.
• Understanding of SOPs, IACUC requirements, NIH guidelines, CDER guidance, ICH guidance OECD guidelines, and related regulations.
• Ability to determine project requirements, study designs, and to perform data analysis of reports from studies conducted in-house.
• Recognizes fundamental anomalies in data points and identifies issues in experiments / processes.
• Begins to understand how to think outside of the technical process and consider the impact decisions will have on the broader scientific goals.
• Strong knowledge of one scientific discipline.
• Good knowledge of scientific principles, methods and techniques.
• Good knowledge and demonstrated ability working with a variety of laboratory equipment/tools.
• Ability to work as part of a team.
• Strong computer skills.
• Good communications, problem-solving, analytical thinking skills.
• Detail oriented.
• Ability to meet deadlines.
• Good project management skills.

Responsibilities

• Work collaboratively with other scientists and colleagues as part of multidisciplinary project teams to ensure tasks are conducted accurately and meet intended scientific objectives.
• Plan, write study protocols, and conduct controlled experiments to characterize toxicological and PK properties of new investigational drugs in accordance to best practices/SOPs.
• Prepare dose formulations and other reagents as instructed.
• Perform test article dosing (IP, IM, SQ, IC, PO), non-terminal biological sample (e.g., blood, CSF, urine, feces, tissues) collection, necropsies, and terminal sample collections.
• Document in vivo study data including but not limited to clinical observations, body weights, food consumption, and environmental findings.
• Perform cell culture, in vitro test article administration, sample collection/processing, and biochemical assays.
• Document in vitro study data including but not limited to culture method, cell viability, and biochemical assay findings.
• Perform ex vivo methods such as DNA/RNA/miRNA/Protein isolation, PCR, NGS, traditional and automated western blot, and immunoassay (e.g., ELISA, Luminex); and related data recording and analysis.
• Perform histopathology (e.g., tissue/cell processing, embedding, microtomy, H&E and special stains, in situ hybridization, immunohisto- and immunocytochemistry, imaging/analysis) and related documentation.
• Collect, analyze, and communicate results as well as assist in preparing reports.
• Attend professional meetings, trainings and/or workshops to gain vital insight into the global toxicological sciences’ landscape and/or present scientific information; and publish in peer-reviewed journals.
• Performs other duties as assigned.

Preferred Qualifications

• Experience with conduct of pharmacokinetic and metabolism studies is highly desirable.
• Experience with micro-sampling techniques is a plus OR MS/MA degree Toxicology or related field and some relevant experience preferred.