Principal Analytical Chemist (Milpitas, CA)
Responsibilities will include, but not be limited to:
- Initiate, direct, and execute all scientific research and/or development strategies in research and/or development
- Investigate the feasibility of applying a wide variety of scientific principles and concepts to potential inventions, products, and problems
- Plan and execute laboratory research for your own work while aiding others as needed
- Maintain broad knowledge of state-of-the-art principles and theories
- Provide support to junior team members with knowledge and guidance for analytical test results, investigations, and analytical team activities
- Develop, establish, and validate testing methodology used to control raw materials, production intermediates and final products (new or existing)
- Establish, validate and document new or existing compound methods
- Conduct work and review of work in compliance with cGMP, safety, and regulatory requirements
- Author research reports, stability reports, test protocols and test reports while aiding others as needed
- May participate in development of patent applications
- Support company goals and objectives, policies and procedures, ISO/MDD/MDR/FDA/ICH requirements, the Quality System Regulation, and other regulatory requirements
- Perform other duties as assigned as needed, collaborating with other functions
Experience:
- Minimum 10 years of relevant, hands-on experience in the medical device/ pharmaceutical/ Biotechnology industry
- Team player with an energy level and drive that motivates and guides those around them to persevere through tough situations and ultimately to meet agreed-upon goals
- Cross-functional collaboration experience in order to support overall company goals
- Good oral and written communication skills
- Basic computer skills
- Bachelor’s degree in science or equivalent relevant experience
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