Gmp, Assoc Scientist​/Eng-, Analytics

GMP ASSOCIATE SCIENTIST/ENGINEER I Position Overview

The Associate Scientist I will support the development, qualification and execution of analytical methods to enable optimization of processes, formulations and characterization of vaccine products. This role involves pharmaceutical and analytical development for GMP production of vaccine products and therapeutics.

• Perform pharmaceutical development and successful GMP release including analytical development.
• Develop product specific release and characterization methods.
• Qualify methods for product release and complete comprehensive characterization of clinical lots.
• Complete GMP testing in line with ICH and regulatory guidance.
• Develop formulations to stabilize vaccine products.
• Employ analytical characterization tools to inform product formulation design.
• Lead formulation & filling of vaccine products including tech transfer and production under GMP conditions.
• Execute and document development and GMP activities in compliance with regulatory requirements.
• Collaborate closely with other development teams to support development activities and understand how production process changes impact product quality.
• Compile data, perform analysis and draw conclusions regarding progress and results of work; summarize data, present results and propose next steps to advance development.
• Write and review development reports; write protocols for tech transfer and SOPs for GMP production; present data to project teams and larger settings.

Minimum:
Bachelor’s degree in a science, engineering, or related field.

Preferred:
None specified.

Competitive benefits package including health insurance plans, generous paid time off, retirement programs with employer contributions, tuition assistance for employees and their children, and more.

Duke is an Equal Opportunity Employer committed to providing employment opportunity without regard to an individual's age, color, disability, gender, gender expression, gender identity, genetic information, national origin, race, religion, sex (including pregnancy and pregnancy‑related conditions), sexual orientation, or military status.

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