Senior Scientist/Principal Investigator-BioAnalytical Services

Frontage Lab • Exton, PA

90d

About The Position

The Senior Scientist/Principal Investigator in Bioanalytical Services at Frontage Laboratories is responsible for validating unique scientific methods, assays, and techniques, and running sensitive, reliable, and efficient LC-MS/MS bioanalytical assays for TK/PK assessment. This role involves performing high-volume sample analysis, data analysis, quality control, and data interpretation while maintaining project schedules and timelines. The position requires effective communication of project timelines and statuses to the Principal Investigator, addressing any issues that may arise. The candidate will simultaneously handle method development and routine sample analysis projects, coordinating study activities to ensure efficiency and quality. Additionally, the role includes maintaining regulatory compliance, aiding in the preparation of study summaries and reports, and mentoring junior scientific staff. The Senior Scientist will also be responsible for the overall conduct of bioanalytical studies, including sample receipt, analysis, reporting, and archiving.

Requirements

• Understanding of experimental design and planning, data collection, and analysis software
• Experience using Sciex Analyst software, and Watson LIMS, a plus
• Proven ability to successfully work in a team environment
• Excellent oral and written communication skills
• Ph.D. in Analytical Chemistry, Biochemistry, Pharmacology or related scientific discipline with 1-2+ years direct experience, OR Master's degree in same disciplines with 4+ years direct experience, OR Bachelor's degree in same discipline with 6+ years direct experience

Responsibilities

• Validate unique scientific methods, assays, techniques, reports, etc.
• Run sensitive, reliable and efficient LC-MS/MS bioanalytical assays for TK/PK assessment
• Perform high-volume sample analysis and/or data analysis, data QC, and data interpretation
• Maintain schedule of projects and timelines
• Communicate project timelines, status, and data to Principle Investigator effectively addressing any issues that may arise
• Simultaneously handle method development routine sample analysis projects as required
• Coordinate study activities with Principle Investigator to ensure efficiency and quality
• Coordinate with Project Management and QC for timely sample analysis and results assessment
• Aid in the preparation of study summaries and/or reports
• Maintain the proper level of regulatory compliance for each study, helping to address QA audit findings
• Maintain tools, computer programs, and SOPs required for studies
• Research literature and external sources and identify new techniques and procedures that strengthen Frontage's capabilities
• Help with training and/or mentoring of junior scientific staff
• Ensure that GLP regulations and SOPs are followed in all bioanalytical service activities
• Set-up, utilize, and maintain complex instrumentation
• Follow safety precautions
• Responsible for overall bioanalytical study conduct, timeline, and communications
• Acts as a primary point of study contact
• Responsible for the scientific and compliance conduct of the study from sample receipt through analysis and reporting including archiving and sample disposition and revenue recognition
• Responsible for all technical related discussion and method development, validation and sample analysis
• Direct, schedule, and mentor lab scientists on projects assigned, and results
• Work with support teams including sample management, lab support, metrology, QC, TW, PM & QA, BD as well as other PIs and management to deliver quality results on time for clients

Benefits

• Health and dental insurance
• 401(k) plan
• Short and long-term disability insurance
• Life insurance

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Industry: Professional, Scientific, and Technical Services
• Education Level: Ph.D. or professional degree
• Number of Employees: 501-1,000 employees