Research Associate, Analytical Development

Summary:

Join Lumen as a Research Associate to support analytical development and assay execution to characterize Lumen’s products, with a particular emphasis on product stability. In this role, you will optimize assays, prepare and label samples, execute testing plans (including stability studies), analyze results, and communicate findings to cross-functional partners to support overall program timelines.

This position is a strong fit for someone who is hands-on, detail-oriented, and highly organized with meticulous laboratory documentation. You will develop and optimize analytical methods for drug substances, drug products, and process intermediates across multiple programs, prepare, generate, and track key assay reagents and materials, analyze and track data to inform method development, and refine and document protocols for routine use and consistency. You will execute assays to characterize product attributes and assay performance, set up, execute, and maintain stability studies to assess product stability, record, review, and trend results while maintaining clear data traceability, and identify, escalate, and help troubleshoot assay or study issues to drive timely resolution. You will communicate across scientific specialties, support assay transfer and lot release, and work in compliance with cGMP requirements as needed.

If you bring a proactive problem-solving approach with a continuous improvement mindset, high integrity, and a strong commitment to quality, we encourage you to apply.

Duties & Responsibilities:

• Method Development:
  • Develop and optimize analytical methods for drug substances, drug products, and process intermediates across multiple programs. 
  • Prepare, generate, and track key assay reagents and materials. 
  • Analyze and track data to inform method development. 
  • Refine and document protocols for routine use and consistency. 
• Assay Execution:
  • Execute assays to characterize product attributes and assay performance. 
  • Set up, execute, and maintain stability studies to assess product stability. 
  • Record, review, and trend results while maintaining clear data traceability. 
  • Identify, escalate, and help troubleshoot assay or study issues to drive timely resolution. 
• Cross-Functional Collaboration:
  • Communicate across scientific specialties, most often partnering with the Quality team. 
  • Support assay transfer and lot release to meet overall program timelines.
  • Work in compliance with cGMP requirements as needed.

Qualifications & Requirements:

• Education and Experience:
  • Bachelor’s or master’s degree in biochemistry, microbiology, or related scientific field. 
  • Minimum of 2 years of relevant experience in one or more of the following: analytical development, immunoassays, and/or high-throughput sample processing. 
• Skills and Attributes:
  • Hands-on, detail-oriented, and highly organized with strong documentation practices. 
  • Strong written and verbal communication skills. 
  • Proactive problem-solver with a continuous improvement mindset. 
  • Experience with analytical assays such as immunoassays, qPCR, enzyme assays, and/or cell-based assays. 
  • Willingness to work in BSL-2 conditions. 
  • High integrity and a strong commitment to quality. 

Physical Requirements:

• Ability to sit/stand for extended periods of time (2 or more hours)
• Occasionally lift or carry up to 23 kg
• Perform delicate manual procedures in the laboratory