Associate Scientist

We're Hiring : Associate Scientist!

We are seeking a dedicated and analytical Associate Scientist to join our research team and contribute to innovative scientific projects. The ideal candidate will have strong laboratory skills, research experience, and the ability to conduct experiments, analyze data, and support product development initiatives.

Location : Gaithersburg, MD

Work Mode :  On-site

Role : Associate Scientist

Summary of Responsibilities :

The qualified individual should have demonstrated proficiency with the development and application of HPLC and / or size separation-based methods for phase-appropriate characterization of protein or vaccine products , including :

Ion Exchange Chromatography (IEX)

Size-Exclusion Chromatography (SEC)

Residual assays via HPLC-UV or HPLC-FLD analysis

The candidate will support the development and qualification of molecular separation assays, OOS investigations, troubleshooting, and writing of SOPs, development reports, and technical reports for testing vaccine products. Collaboration with cross-functional teams is expected.

A solid understanding of FDA and ICH guidelines , as well as practical knowledge of assay validation , is required.

Key Responsibilities (include but are not limited to) :

Develop HPLC-related methods for the separation and identification of related proteins and / or impurities in nanoparticle vaccine products

Lead experimental designs to characterize Drug Substance and Drug Product materials from Novavax and / or CMO sites

Follow SOPs to test in-process samples using HPLC in support of process development and stability studies

Draft qualification and / or validation protocols for test methods used to evaluate in-process samples

Participate in cross-functional workflows and provide scientific guidance to internal teams

Minimum Requirements :

MS in analytical science, chemistry, biochemistry, or related field with 4+ years of industry experience in biopharmaceutical and / or vaccine development

BS in analytical science, chemistry, biochemistry, or related field with 6+ years of industry experience in biopharmaceutical and / or vaccine development

Ability to critically analyze data using statistical tools and compile and review technical reports

Ability to define priorities and follow through to get things done

Knowledge and expertise in the principles and practice of current Good Manufacturing Practices (GMPs) is preferred

Excellent record-keeping skills to adequately record, analyze, and document analytical data for regulatory requirements

Understanding of statistical tools; knowledge of DOE (Design of Experiments) and QbD (Quality by Design) principles is a plus

Strong communication, presentation, and writing skills