Sr. Analytical Chemist
Major Duties and Responsibilities
Responsibilities will include, but not be limited to:
- Perform analytical chemistry research to develop assays based on new and existing methodologies
- Develop establish and validate testing methodology used to control raw materials, production intermediates and final products
- Establish, validate and document new or existing compound identification methods
- Conduct work in compliance with cGMP, safety and regulatory requirements
- Knowledge of FDA, ICH and/or other regulatory guidance documents desirable
- Provide analysis and evaluation of material and products at all stages of development process
- Plan and execute laboratory research
- Maintain broad knowledge of state-of-the-art principles and theories
- Make major contributions to scientific literature and conferences
- May act as spokesperson on corporate research and development and advise top management
- May participate in development of patent applications
- Support company goals and objectives, policies and procedures, ISO/MDD/MDR requirements, the Quality System Regulation, and other regulatory requirements
Qualifications
Experience
- Minimum 6 years of relevant experience in transferable medical device/pharmaceutical industry
- Team player with an energy level and drive that motivates those around him/her to persevere through tough situations and ultimately to meet agreed-upon goals
- Cross-functional collaboration will be an essential part of the role in order to support overall company goals
- Good oral and written communication skills
- Basic computer skills
Education Requirements
Bachelor degree in Chemistry or equivalent education/experience required