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Fellow - Analytical Sciences - OINDPs
3 months ago
Kelly Science has a new opening for Fellow-Analytical Sciences in OINDPs in the Miami FL metro area for one of our growing clients. This is a great opportunity to join a team of motivated scientists helping to create products to help those in need.
Provides expertise in Analytical Sciences, offering leadership in the selection and implementation of analytical techniques for various projects. Manages the development, optimization, and validation of analytical methods. Drafts scientific documents compliant with regulatory standards. Oversees laboratory activities and conducts physico-chemical characterization studies, particularly focusing on liquid chromatography, spectroscopy, and aerosol performance techniques for orally inhaled and nasal drug products (OINDP). Leads evaluation of raw materials and formulation studies, ensuring compliance with cGMPs and relevant guidelines. Develops extractables and leachables (E&L) methods and evaluates new analytical technologies. Analyzes and communicates analytical data, mentors team members, and contributes to regulatory dossiers.
Essential Duties and Responsibilities:
- Provide expertise in Analytical Sciences.
- Lead selection and implementation of analytical techniques.
- Conduct physico-chemical characterization studies for OINDP.
- Act as a subject matter expert in analytical methodologies for OINDPs.
- Lead characterization studies for raw materials and formulation.
- Oversee laboratory activities and data analysis.
- Draft protocols, reports, and submission documents.
- Supervise analytical activities for regulatory submission.
- Present data and recommendations to senior management.
- Communicate effectively with team members and stakeholders.
- Troubleshoot technical issues and propose solutions.
- Drive continuous improvement in laboratory processes.
- Develop and implement training programs.
- Mentor junior scientists.
- Ensure compliance with SOPs and safety rules.
Qualification Requirements:
- Ph.D. or 12-15 years of experience in relevant fields.
- Expert knowledge of analytical chemistry and aerosol characterization.
- Advanced understanding of method validation and E&L concepts.
- Proficiency in data analysis tools and regulatory documentation.
- Experience in OINDP characterization and project management.
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