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Senior Scientist/Principal Investigator-BioAnalytical Services

Frontage Laboratories, Inc

Exton (Chester County)

On-site

USD 80,000 - 110,000

Full time

30+ days ago

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Qualifications

  • Ph.D. or Master’s in relevant fields with significant experience in bioanalytical methods.
  • Strong understanding of regulatory compliance and ability to work in teams.

Responsibilities

  • Validate and run bioanalytical assays for TK/PK assessment.
  • Coordinate projects and maintain regulatory compliance for studies.

Skills

LC-MS/MS bioanalytical assays
Data analysis
Regulatory compliance
Experimental design
Communication skills

Education

Ph.D. in Analytical Chemistry, Biochemistry, or Pharmacology
Master’s degree in related disciplines
Bachelor’s degree in related disciplines

Tools

Sciex Analyst software
Watson LIMS
Data collection and analysis software

Job description

Senior Scientist/ Principal Investigator, Bioanalytical Services

Location: Exton, PA (Corporate)

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
  • Ability to work on multiple projects at the same time
  • 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 PI’s and management to deliver quality results on time for clients.

Education and 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.

Salary and Benefits:

Frontage Laboratories Inc. is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a protected veteran, among other things, or status as a qualified individual with disability.

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