Scientist, Pharmacokinetics Full-time

Bioanalytical Scientist

The Department of Pharmacokinetics, Dynamics, Metabolism, and Bioanalytics (PDMB) is seeking a bioanalytical scientist to join our Regulated PK & ADA Bioanalytical group at West Point, PA. We are looking for a highly motivated candidate with experience in advanced analytical method design through the use of automation and operational support of bioanalytical labs conducting bioanalysis of biotherapeutics in regulated drug development studies. Collaboration, innovation, teamwork, and accountability are highly valued within our team. The successful candidate will play a key role in designing, planning, and utilizing automation methods during method development, validation, and sample analysis of bioanalytical assays for our Company's pipeline.

Main Responsibilities include but are not limited to:

• Assist in establishing and managing bioanalytical lab operations, including lab automation, analytical instrumentation, and data handling.
• Contribute to the development, validation and implementation of novel automated workflows.
• Work collaboratively with department members to operate and troubleshoot automated laboratory equipment and systems in support of various bioanalytical assays within our Company's pipeline.
• Manage data integrity through automated processes.
• Support timely delivery of high-quality quantitative data to cross-functional collaborators for bioanalytical analysis.
• Collaborate to identify, evaluate, and recommend novel and cutting-edge automation and assay strategies to drive our development programs, including machine learning and artificial intelligence.

Education Minimum Requirements:

• B.A./B.S. in Engineering, Automated Sciences, Chemistry, Biochemistry, Pharmaceutical Sciences, or related discipline with a minimum of 3 years of relevant experience.
• Master's Degree with 1 to 3 years of relevant experience

Required Experience and Skills:

• Demonstrated expertise operating various automation platforms (e.g. Hamilton, Tecan, Biomek) to perform method development and sample testing of preclinical and clinical assays
• Experience in development and execution of quantitative and qualitative bioanalytical assays (e.g. ELISA, mass spectrometry)
• Knowledge of GLP requirements and understanding of current industry trends and regulatory expectations associated with bioanalytical science.
• Knowledge and experience with data visualization tools (i.e. PowerBI, Spotfire, etc.)
• Strong verbal and written communication skills
• Experience in good documentation practices.
• Self-starter with ability to work independently.
• Ability to follow procedures and thoroughly document experiments.
• Capable of working efficiently and multitasking in a fast-paced environment
• Ability to re-prioritize workload to support team based on immediate need
• Emphasizes a team-based approach and is dedicated to collaborative and harmonious work with others.

Preferred Experience and Skills:

• Experience with computer languages and building applications (e.g. VB, Python, C#, labview, Microsoft PowerApps)
• Previous work experience in regulated industry environment and a solid understanding of current GLP standards

Required Skills:

Bioanalysis, Biochemistry, Data Analysis, Data Visualization, Detail-Oriented, Drug Metabolism, Ethical Compliance, GMP Documentation, Good Laboratory Practices (GLPs), Immunoassays, Ligand Binding Assay, Liquid Chromatography-Mass Spectrometry (LC-MS), Pharmacokinetics

Preferred Skills:

Analytical Instrumentation, Automated Liquid Handling Systems, Biochemistry Techniques, Biological Analysis, C# Automation, LabVIEW(Laboratory Virtual Instrument Engineering Workbench), Microsoft Power Apps, Programming Languages, Python (Programming Language)