Analytical Development Principal Research Associate

About the role

The Analytical Development Principal Research Associate position at Vertex is responsible for independently performing complex experimental procedures and developing assays in compliance with USP guidelines. The role involves working closely with cross-functional teams to achieve program goals within established timelines.

Responsibilities

• Independently perform complex experimental procedures using various technical platforms, including ELISA, flow cytometry, cell culture, cell-based bioassays, and HPLC.
• Independently develop ELISA and plate-based binding assays with minimal oversight, in accordance with USP guidelines for biologic assays.
• Improve and transfer a research-grade assay to a GMP test lab.
• Work collaboratively with cross-functional teams providing technical support to achieve program goals within established timelines and demonstrating excellent documentation skills.
• Report experimental findings and results to team members in an organized and clear manner.
• Author method documents, analytical protocols, and reports.
• Contribute to lab organization and efficient lab functioning.
• Design development studies with the ability to efficiently assess assay performance.
• Perform statistical analysis of experimental data and interpret results.
• Trend method performance of GMP release and stability assays, identify areas of improvement, and conduct experiments.
• Interact with vendor and contract test labs to transfer and qualify methods following ICH, USP and EP guidelines.
• Design, conduct, and trend stability studies using appropriate statistical tests per ICH and EMA guidelines.
• Present data at cross-functional meetings.

Requirements

• A Bachelor’s degree, or foreign equivalent, in Biology, Analytical Sciences, Biochemistry, Biological Sciences, Pharmacology and Drug Development, or a related field and 5 years of experience in the job offered or in an Analytical Development Principal Research Associate-related occupation.
• Alternatively, a Master’s degree, or foreign equivalent, in Biology, Analytical Sciences, Biochemistry, Biological Sciences, Pharmacology and Drug Development, or a related field and 3 years of experience in the job offered or in an Analytical Development Principal Research Associate-related occupation.
• Demonstrable experience in cell culture of primary and secondary cell lines, cell line transfections, polymerase chain reaction (PCR), enzyme-linked immunosorbent assay (ELISA), flow cytometry, gel electrophoresis, high performance liquid chromatography (HPLC), statistical programs including John’s Macintosh Project (JMP), and GraphPad Prism.
• Method development and troubleshooting experience with plate-based binding assays including ELISA, AlphaLISA, and HTFR.
• Proven technical proficiency and demonstrated skill in designing, executing, and interpreting experiments. Experiments include linearity, accuracy, precision, spike recovery, and forced degradation.
• Analysis and interpretation of complex experimental data with proficiency in problem solving.
• Emerging knowledge of regulatory guidance for analytical development. Regulatory guidance includes International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) Quality Modules for method development and validation and United States Pharmacopeia (USP) guidance chapters for biologic method development and validation.
• Knowledge and hands-on experience with analytical platforms including JMP and GraphPad Prism used for characterization and release assays.

Pay

$109,533.00 - $128,500.00