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Senior Analytical Chemistry Specialist
2 months ago
As a Senior Analytical Chemistry Specialist at CoreRx Inc, you will play a pivotal role in ensuring compliance with pharmaceutical standards and regulations. Your expertise will contribute to the development and implementation of analytical methodologies that adhere to GLP, cGMP, and ICH-QbD guidelines.
KEY RESPONSIBILITIES
- Possess a thorough understanding of pharmaceutical regulations and best practices in analytical chemistry, aiding in the strategic planning for innovative and cross-functional projects.
- Lead or actively participate in functional sub-teams, contributing your analytical expertise to various cross-functional initiatives.
- Utilize advanced technical skills to design and execute study protocols, conducting experiments with sophisticated analytical instruments such as HPLC, GC, FT-IR, and UV-VIS spectrophotometry.
- Independently assess and interpret complex analytical methods, ensuring timely implementation in laboratory settings.
- Apply foundational concepts of HPLC methods to support validation processes effectively.
- Implement ICH regulations for method validation in early-phase development projects.
- Conduct method feasibility studies, making necessary adjustments to parameters to achieve optimal results.
- Document laboratory activities meticulously in reports and other essential documentation.
- Exhibit strong scientific leadership in separation science, consistently delivering high-quality results.
- Troubleshoot intricate analytical challenges, devising innovative solutions through collaboration and creativity.
- Mentor colleagues in the use of complex instrumentation, providing guidance across multiple projects.
- Manage diverse tasks efficiently, adhering to standard work practices while executing projects with minimal oversight.
- Demonstrate excellent communication skills, fostering effective interactions with cross-functional teams.
- Contribute to scientific advancements through presentations, posters, and publications.
- Ensure the timely achievement of project milestones while optimizing resource utilization.
A minimum of 4 years of experience in a pharmaceutical laboratory environment is required.
EDUCATIONAL BACKGROUND
A Bachelor’s degree in a scientific discipline is required; a Master’s degree with 2 years of relevant experience is preferred.