Associate Scientist Analytical Development LCMS - Contract - Gaithersburg, MD
Proclinical is seeking an Associate Scientist to join a Analytical Development team. this is a temporary contract based in Gaithersburg, Maryland.
Primary Responsibilities:
The ideal candidate will be proficient in the development and application of HPLC and/or Size Separation based methods for the characterization of protein or vaccine products. This role involves supporting the development and qualification of molecular separation assays, troubleshooting, and writing SOPs and technical reports. A good understanding of FDA and ICH guidelines and practical knowledge with assay validation is essential.
Skills & Requirements:
- MS in analytical science, chemistry, biochemistry, or related field with industry experience in biopharmaceutical and/or vaccine development.
- Ability to critically analyze data using statistical tools and to compile and review technical reports.
- Ability to define priorities and process to get things done.
- Knowledge and expertise in the principles and practice of current Good Manufacturing Practices (GMPs) is preferred.
- Excellent record keeping abilities to adequately record, analyze, and document analytical data generated in support of regulatory requirements.
- Good understanding of statistical tools and knowledge of DOE (Design of Experiments) and QbD (Quality by Design) principles is a plus.
- Strong communication, presentation, and writing skills.
The Associate Scientist Analytical Development's responsibilities will be:
- Develop HPLC related methods for the separation and identity of related proteins and/or impurities in nanoparticle vaccine products.
- Lead experimental designs to characterize Drug Substance and Drug Product materials.
- Test in-process samples using HPLC to support process development and stability studies of nanoparticle vaccines.
- Draft qualification and/or validation protocols for test methods to evaluate in-process samples.
- Participate in cross-functional workflows and provide scientific guidance to teams.
- Apply new technologies to improve throughput for in-process testing and enhance product characterization.
- Perform method transfers to QC and other groups and external partners.
- Maintain effective communication within Analytical Development and cross-functional teams.
- Present scientific findings at internal and external meetings.
If you are having difficulty in applying or if you have any questions, please contact Parker Jensen at (+1) 267-297-3376 or p.jensen@proclinical.com.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.
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