Analytical Development Principal Research Associate (Biotech)

TL;DR

Analytical Development Principal Research Associate (Biotechnology): Designing and executing characterization and release assays for cell-based products with an accent on assay performance and regulatory compliance. Focus on optimizing analytical platforms like RT-qPCR, ELISA, and Flow cytometry to support pluripotent stem cell Process Development.

Location: On-site in Boston, MA (five days per week)

Salary: $100,755.00 - $128,500.00 per year

Company

Vertex is a global biotechnology company that invests in scientific innovation.

What you will do

• Design, develop, and execute characterization and release assays for cell-based products using platforms such as RT-qPCR, ELISA, Flow cytometry, and ddPCR.
• Support pluripotent stem cell Process Development through the execution of test methods.
• Troubleshoot, optimize, and trend assay performance to ensure reliability.
• Author technical documents, including analytical development protocols, qualification reports, and recommendations for management.
• Qualify and manage analytical reagents in accordance with regulatory standards.
• Establish assay design criteria using Design of Experiments (DOE) and perform statistical analysis for specificity and accuracy.

Requirements

• Master's degree in Biochemistry, Cell & Molecular Biology, Pharmacology, or related field with 2 years of experience, OR a Bachelor's degree with 6 years of experience.
• Must be based in Boston, MA, and work on-site five days per week.
• Demonstrable experience developing analytical methods in compliance with ICH guidelines.
• Hands-on experience with assay platforms: RT-qPCR, ELISA, Western blots, or Flow cytometry.
• Experience with the culture of multiple mammalian cell types and combination drug products.
• Ability to write complex technical documents and qualification protocols.

Culture & Benefits

• Competitive compensation including annual bonus and annual equity awards.
• Comprehensive medical, dental, and vision insurance.
• Generous paid time off, including company-wide summer and winter shutdowns.
• Educational assistance programs, including student loan repayment.
• 401(k) plan and commuting subsidies.