Principal Analytical Chemist (Milpitas, CA)

MAJOR DUTIES AND RESPONSIBILITIES
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

QUALIFICATIONS
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

EDUCATION REQUIREMENTS

• Bachelor's degree in science or equivalent relevant experience