Senior Project Scientist

Company: Celerion
Location: Lincoln
Posted on: November 22, 2021

Job Description:

Celerion is committed to swift, exceptional clinical research through translational medicine. Every day, we use our experience, agility, and innovative research strategies to help get drugs to market faster. Celerion offers one of the most experienced clinical pharmacology research networks in the industry. Are you looking for an opportunity to support a business creating life-saving treatments? If so, we can't wait to meet you! Celerion in Lincoln, NE is seeing a full-time Senior Bioanalytical Project Scientist to join our Bioanalytical Division. As a Senior Project Scientist, you will provide scientific review and oversight of bioanalytical projects with all levels of complexity and with minimal supervision. You will support associates in production and validation, provide guidance and technical training, problem-solving, assist with study scheduling and bioanalytical study management. You will be responsible for mentoring and project oversight of studies assigned to a Bioanalytical Project Scientist and /or Assistant Project Scientist. Essential Functions*

• Work with Method Development personnel during the early stages of a project to ensure the method is suitable
• Support validation activities.
• Design pre-study plan and guide analysts in pre-study work.
• Identify issues with assay performance and work with appropriate personnel to resolve and/or troubleshoot
• Review and approve study data.
• Conduct all work in compliance with applicable GLPs, SOPs, policies, safety, and other regulatory requirements.
• Document event observations and deviations and assist BPI with testing plans and impact assessments.
• Mentor and train bioanalytical analysts and project scientists in all aspects of production and validation support.
• Support BPI to ensure all QC/QA findings are completed in a timely manner.
• Support the BPI in the overall study management.
• Positively influence junior staff to achieve results that are in the best interest of the organization and contribute to a positive work culture.
• Author and review standard operating procedures. Qualifications
  • Bachelor's degree in a science-related field or equivalent training with 10 years of analytical experience preferred OR
  • Masters degree in a science-related field or equivalent training with 3-5 years analytical experience preferred OR
  • Ph.D. in science-related field or equivalent training with 2-3 years analytical experience preferred.
  • 2 years experience in method validation or 3 or more years as a Project Leader preferred.
  • 3-6 years previous laboratory and/or GLP knowledge preferred.
  • Knowledge of all regulatory compliance procedures.
  • Excellent oral and written skills.As a leader in transitional medical research, Celerion considers COVID safety of paramount importance. We have participated in COVID vaccination trials and related research. We have also implemented strict protocols to ensure the safety of our onsite associates and study participants. We continue to refine our approach and processes as CDC guidance and our understanding of the virus evolves. Celerion Values: Integrity Trust Teamwork Respect Are you ready to join our team? Celerion is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, age, sexual orientation, gender identity, genetic information, marital status, qualified protected veteran status, or disability.

Keywords: Celerion, Lincoln , Senior Project Scientist, Other , Lincoln, Nebraska