GMP, Associate Scientist/Engineer I, Analytics

Duke Clinical Research Institute; Durham (NC); On-site; USD 48,000 - 87,000; Full time

Job summary

Duke Human Vaccine Institute in Durham, NC seeks an Associate Scientist I to support analytical development and GMP production of vaccine products. The role involves developing release and characterization methods and ensuring GMP compliance.

The position emphasizes collaboration with cross-functional teams, data analysis, and documentation to advance development and regulatory readiness. Competitive benefits are provided by Duke University.

Qualifications

• Bachelor's degree in science, engineering, or related field.
• Experience with pharmaceutical development and GMP release preferred.
• Ability to write and review development reports and SOPs.

Responsibilities

• Perform pharmaceutical development and GMP release including: Analytical development.
• Develop product release and characterization methods.
• Qualify methods for product release and complete comprehensive characterization of clinical lots.
• Lead formulation & filling of vaccine products including tech transfer under GMP.

Skills

Analytical development

GMP knowledge

Tech transfer

Data analysis

Education

Bachelor's degree in science/engineering

Job description

School of Medicine Established in 1930, Duke University School of Medicine is the youngest of the nation's top medical schools. Ranked sixth among medical schools in the nation, the School takes pride in being an inclusive community of outstanding learners, investigators, clinicians, and staff where interdisciplinary collaboration is embraced and great ideas accelerate translation of fundamental scientific discoveries to improve human health locally and around the globe. Composed of more than 2,600 faculty physicians and researchers, nearly 2,000 students, and more than 6,200 staff, the Duke University School of Medicine along with the Duke University School of Nursing, and Duke University Health System comprise Duke Health, a world-class academic medical center. The Health System encompasses Duke University Hospital, Duke Regional Hospital, Duke Raleigh Hospital, Duke Health Integrated Practice, Duke Primary Care, Duke Home Care and Hospice, Duke Health and Wellness, and multiple affiliations.

GMP ASSOCIATE SCIENTIST/ENGINEER I

GMP Analytics - Duke Human Vaccine Institute

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 incumbent in this position will be involved in pharmaceutical and analytical development for GMP production of vaccine products and therapeutics.

Minimum Requirements:

Generally requires a bachelor's degree in a science, engineering, or related field.

Preferred Qualifications:

N/A

Position Description:

• 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.
• Formulation development 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 provide support for development activities and will work diligently with other development functions to understand how the production process changes impact product quality.
• Compile data and perform analysis and interpretation and draw conclusions regarding progress and results of work, utilizing the data in appropriate decision making; summarize data, present results and propose next steps to advance development.
• Write and reviews development reports; writes protocols for tech transfer and SOPs for GMP production, and presents data to project teams and larger settings.

Choose Duke.

Join our award-winning team and be part of an inclusive culture that values excellence, innovation, and discovery. Duke University is consistently ranked among the top universities worldwide and is renowned for its cutting-edge research across disciplines. Beyond the engaging work, you'll also benefit from Duke's 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.

Anticipated Pay Range: Duke University provides an annual base salary range for this position as USD $48,137.00 to USD $86,631.00. Duke University considers factors such as (but not limited to) scope and responsibilities of the position; candidate's work experience, education/training, and key skills; internal peer equity; as well as market and organizational considerations when extending an offer.

Your total compensation goes beyond the dollars on your paycheck. Duke provides comprehensive and competitive medical and dental care programs, generous retirement benefits, and a wide array of family-friendly and cultural programs to eligible team members. Learn more at: https://hr.duke.edu/benefits/

Equal Opportunity Employer: 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.

Duke aspires to create a community built on collaboration, innovation, creativity, and belonging. Our collective success depends on the robust exchange of ideas-an exchange that is best when the rich diversity of our perspectives, backgrounds, and experiences flourishes. To achieve this exchange, it is essential that all members of the community feel secure and welcome, that the contributions of all individuals are respected, and that all voices are heard. All members of our community have a responsibility to uphold these values.

Essential Physical Job Functions:

Certain jobs at Duke University and Duke University Health System may include essential job functions that require specific physical and/or mental abilities. Additional information and reasonable accommodation(s) can be requested with Duke Access and Accommodations Services (email: [e-mail]; phone: [phone]).