Scientist, Toxicology Full-time

Nonclinical Drug Safety Scientist

The Nonclinical Drug Safety (NDS) group at the West Point, PA site is seeking a highly motivated individual with strong technical and communication skills and attention to detail to join the Central Pharmacy laboratory within the Toxicological Sciences group. Central Pharmacy is responsible for the preparation of vehicle and test article dosing formulations to support Good Laboratory Practices (GLP)-compliant and exploratory nonclinical studies. Additional study support activities include maintaining documentation in an electronic document management system, coordinating collection of samples of dosing formulations for analysis, authoring the test and control article information section of study reports, and receiving and shipping materials to support internal and Contract Research Organization studies. Scientists also maintain the pharmacy's test and control article, chemical, GLP reserve sample, and controlled substance inventories.

This position is for a 5 day/week work week, including coverage of weekends and holidays on a rotational basis.

Primary Responsibilities:

• Follow Standard Operating Procedures (SOPs), GLP's, and safety requirements.
• Perform tasks to execute assigned nonclinical studies.
• Collaborate with study stakeholders.
• Review and verify the test and control article section of the study protocol.
• Create dosing formulation preparation instructions to support various routes of administration including oral, intravenous, intramuscular, and subcutaneous.
• Perform accurate weighing of test and control articles.
• Prepare suspension and/or solution dose formulations daily or in bulk based on stability information using weight to weight or weight to volume techniques.
• Utilize standard formulation equipment such as a stir plate, water bath sonicator, pH meter, and homogenizer.
• Compile test and control article documentation needed to support the study.
• Author the test and control article sections of study reports.
• Apply sound basic laboratory skills that include observing, recording, and assessing data.
• Maintain accurate and highly detailed laboratory records.
• Work with several data acquisition computer systems/applications.
• Maintain laboratory functionality and inspection readiness by accurate maintenance of the CP inventory including compounds, lab supplies, and equipment.

Other responsibilities may include:

• Contribute to Central Pharmacy and cross-functional projects.
• Train and work cross-functionally in other areas within NDS and Preclinical Development.

Educational Minimum Requirements:

• BS/BA in Chemistry, Biology, or a related discipline with some relevant laboratory experience.

Required Experience and Skills:

• 1+ year of relevant laboratory experience.
• Knowledge of the chemistry of solutions and suspensions, including concentration, weight, and volume measurements, density, and other aspects of weight to volume/weight preparations.
• Strong listening, communication (verbal and written), and collaboration skills.
• Ability to problem solve in a fast-paced environment and deliver results to meet timelines.
• Ability to work independently on assigned nonclinical studies and projects as well as being able to work in teams both within Central Pharmacy and cross departmentally, while adhering to the highest standards of trustworthy and ethical behavior in all interactions.
• Familiarity with recording and assessing laboratory data.
• Working knowledge of Microsoft Office suite, predominately Outlook/Teams, Word, Excel, and PowerPoint.

Preferred Experience and Skills:

• Experience in the pharmaceutical industry or biotech, or similar.
• Regulatory awareness, including GLP and ALCOA principles.
• Experience with electronic data capture for nonclinical studies.
• Basic knowledge of the drug development process.

Required Skills:

Chemical Safety, Communication, Detail-Oriented, Experimentation, Laboratory Maintenance, Laboratory Techniques, Regulatory Awareness, Standard Operating Procedure (SOP), Teamwork

Preferred Skills:

Good Laboratory Practices (GLPs), Pharmaceutical Sciences, Toxicology