Job Description

MAJOR DUTIES AND RESPONSIBILITIES

Responsibilities will include, but are not limited to:

1. Initiate, direct, and execute all scientific research and/or development strategies in research and/or development.
2. Investigate the feasibility of applying a wide variety of scientific principles and concepts to potential inventions, products, and problems.
3. Plan and execute laboratory research for your own work while aiding others as needed.
4. Maintain broad knowledge of state-of-the-art principles and theories.
5. Provide support to junior team members with knowledge and guidance for analytical test results, investigations, and analytical team activities.
6. Develop, establish, and validate testing methodology used to control raw materials, production intermediates, and final products (new or existing).
7. Establish, validate, and document new or existing compound methods.
8. Conduct work and review of work in compliance with cGMP, safety, and regulatory requirements.
9. Author research reports, stability reports, test protocols, and test reports while aiding others as needed.
10. May participate in development of patent applications.
11. Support company goals and objectives, policies and procedures, ISO/MDD/MDR/FDA/ICH requirements, the Quality System Regulation, and other regulatory requirements.
12. Perform other duties as assigned as needed, collaborating with other functions.

QUALIFICATIONS

Experience:

1. Minimum 10 years of relevant, hands-on experience in the medical device/pharmaceutical/Biotechnology industry.
2. 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.
3. Cross-functional collaboration experience in order to support overall company goals.
4. Good oral and written communication skills.
5. Basic computer skills.

EDUCATION REQUIREMENTS

• Bachelors degree in science or equivalent relevant experience.

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