R&D Chemist

• Location: Saint Paul, Minnesota
• Type: Direct Hire
• Job #66963
• Salary: $64,480

Leading pharmaceuticals company in Saint Paul, MN is looking for an R&D Chemist to join their growing team. This is a direct hire opportunity

Responsibilities of the R&D Chemist:

• Provide analytical support to a designated range of products enabling revenue growth, increased laboratory capability, and enhanced lab quality compliance.
• Ensure all feasibility work, analysis, validation, stability, industry trials, and development are performed on time, meeting QbD standards and meet all regulatory requirements.
• Analytical support for all KPIs for the laboratory and operations.
• Analytical support scale up activities for all projects to commercial scale.
• Analytical development, optimization and scale up of all dosage forms.
• Create and review technical documents including analytical method development reports, method development/validation protocols and reports, standard operating procedures in compliance with regulatory requirements.
• Perform bench work such as HPLC, GC and dissolution.

• Bachelor's degree in relevant science field with minimum 1-3 years' experience.
• A minimum 1-3 years' experience in a cGMP or cGLP laboratory environment required.
• Knowledge of analytical techniques including HPLC. (GC, FTIR and dissolution experience a plus)
• Experience using chromatographic software (Empower 3 - strongly preferred).
• Excellent analytical, technical writing, communication and data management skills to present data to internal technical and project teams & potentially to clients.
• Proven scientific and technical ability to design and execute experimental studies as well as statistically analyze data, author and review protocols and reports.
• Must be able to think critically and troubleshoot typical analytical (HPLC) instrumentation problems.
• Knowledge & experience with cGMP, cGLP, USP and the regulatory requirements for pharmaceuticals.
• Highly motivated and self-driven individual with ability to work independently, and multi-task, adhere to aggressive timelines in support of department and company objectives.
• 2-3 years' experience in the FDA drug/pharmaceutical industry
• Demonstrated in-depth scientific knowledge & experience in analytical method development, & validation
• Experience in the development of pharmaceutical dosage forms and polymeric drug delivery systems with emphasis in transdermals.
• Experience in statistical data analysis and QbD principles
• An understanding of polymer science, analytical development, drug and formulation characterization, optimization and scale-up