Senior Analytical Development Scientist
2 weeks ago
Job Summary
EPM Scientific is seeking a highly skilled Principal Scientist of Analytical Development to join our team. As a key member of our Analytical Department, you will be responsible for leading multiple projects from early to late stages of development, designing and executing experiments to support drug development programs, and analyzing data to ensure the accuracy and reliability of analytical methods.
Key Responsibilities
- Lead projects ranging from early to late stages of development, ensuring timely and cost-effective delivery of results.
- Design and execute experiments to support drug development programs, including method development, optimization, and validation.
- Analyze data and interpret results to ensure the accuracy and reliability of analytical methods, and make recommendations for process improvements.
- Ensure compliance with regulatory requirements and industry standards in all analytical activities, and maintain up-to-date knowledge of relevant regulations and guidelines.
- Contribute to the strategic direction of the analytical development function within the organization, and collaborate with cross-functional teams to support product development and regulatory submissions.
- Mentor and train junior scientists to develop their technical skills and expertise in analytical development, and provide guidance and support to ensure their success.
- Stay up-to-date with new technologies and trends in analytical development, and continuously improve processes and capabilities to ensure the organization remains competitive.
- Participate in scientific conferences, publications, and industry forums to share knowledge and expertise in the field of analytical development, and stay informed about industry developments and best practices.
Requirements
- A Ph.D. or Master's degree in Analytical Chemistry, Pharmaceutical Sciences, or a related field, with 6+ years of experience in the pharma industry.
- Extensive experience in small molecule analytical method development, validation, and characterization of pharmaceutical products, in a research and development setting.
- Strong knowledge of analytical techniques, such as HPLC, GC, spectroscopy, mass spectrometry, and chromatography.
- Experience with regulatory requirements and guidelines, such as FDA, ICH, and USP.
- Demonstrated leadership and project management skills, with the ability to lead and mentor a team of scientists.
- Excellent communication skills, both written and verbal, to effectively collaborate with cross-functional teams and present scientific findings.
- Strong problem-solving skills and attention to detail to ensure the accuracy and reliability of analytical methods.
- Ability to work independently and prioritize tasks in a fast-paced and dynamic environment.
- Continuous learning mindset to stay updated on new technologies and trends in analytical development.
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