Great opportunity for a Chemist to join this top medical device company and be a part of their R&D team. This is a direct-hire opportunity located in St. Paul. Be a part of some cutting-edge work!
As an R&D Chemist you will:
- 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 4-6 years experience.
- A minimum 4-6 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.
- 6+ 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
- Leadership and previous supervisory experience a plus
DAVIS Companies partners with the top employers locally and nationally. They choose us because of our reputation for finding high quality talent, fast, but also our experience for evaluating and representing the best candidates in the marketplace. We make every effort to provide updates and feedback to candidates at each stage of the process as we appreciate how stressful looking for a new role can be. Apply today and experience “The DAVIS Difference”.