R&D Chemist Ii

Job Title: R&D Chemist I

Department/Division: Laboratory

Reports to: Analytical Sr. Scientist

Job Summary:

Duties/Responsibilities:

· 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.

Education and Experience:

· 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.

Preferred Skills/Abilities:

· 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

Job Type: Full-time

Pay: $67,000.00 - $73,000.00 per year

Schedule:

• Day shift

Ability to Relocate:

• Saint Paul, MN 55118: Relocate before starting work (Required)

Work Location: In person