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Senior Analytical Method Development Scientist

2 months ago

Indianapolis Indiana, United States Eurofins USA PSS Insourcing Solutions Full time
Job Summary

We are seeking a highly skilled Senior Analytical Method Development Scientist to join our team at Eurofins USA PSS Insourcing Solutions. As a key member of our analytical team, you will be responsible for developing and characterizing stability-indicating methods for early-phase pharmaceutical small to medium molecules.

Key Responsibilities
  • Method Development and Validation: Develop and validate analytical methods for pharmaceutical small molecules using instrumentation such as UPLC/HPLC, Dissolution, GC, Thermogravimetric DSC/TGA, and KF titration.
  • Technical Discussions and Problem-Solving: Participate in technical discussions with project leads to recommend alternatives, research new methods/techniques, and discuss potential solutions to problems.
  • Experimental Planning and Execution: Plan critical laboratory experiments to investigate aberrant results, determine root cause, and recommend action plans.
  • Documentation and Reporting: Write Standard Operating Procedures (SOPs), assist in generating technical reports, prepare data for presentations/technical discussions, and transfer methods internally and externally.
  • Mentorship and Training: Assist and mentor junior-level scientists on analytical techniques and troubleshooting issues.
  • Project Management: Ensure project deliverables are scientifically accurate and meet timeline expectations.
  • Compliance and Safety: Comply with all laboratory safety guidelines, including Personal Protective Equipment (PPEs), and maintain general cleanliness of the lab.
Requirements
  • Deep Understanding of Analytical Sciences: Possess a deep understanding of analytical sciences, drug development process, GMP/GLP requirements, and pharmaceutical industry trends.
  • Pharmaceutical Experience: Have previous experience in pharmaceutical oral solid dosage & parenteral drug product analytical testing.
  • Knowledge of Pharmacopoeias and ICH Guidelines: Have good knowledge of three main pharmacopoeias (Japanese; JP, US; USP and European; Ph. Eur.) and ICH guidelines related to method development and validation.
  • Empower Software and Data Analysis: Have experience in developing pharmaceutical small molecules analytical chemistry methods for dissolution multi-media screening and analyzing data using compendial methods.
  • Project Management and Communication Skills: Possess excellent project management skills, ability to communicate complex scientific findings/recommendations and project resource requirements, and elevate relevant issues to project lead and line-management.
  • Teamwork and Adaptability: Be able to work independently and as part of a team with internal and external clients, self-motivation, adaptability, and a positive attitude.
  • Continuous Learning and Innovation: Be able to learn new techniques, perform multiple tasks simultaneously, keep accurate records, follow instructions, and comply with company policies.
  • Transfer of Analytical Technologies: Have experience in exploration and application of innovative technologies/approaches to analytical development activities and transfer of analytical technologies.
  • Performance Management and Prioritization: Be able to drive performance by tracking and managing key performance indicators using internal and external metrics and prioritize complex workloads and manage changing priorities.
  • IT Skills: Possess proficiency in IT-related skills such as Microsoft Excel, Word, PowerPoint, etc.