Process Development Associate Scientist

Role Summary

Process Development Associate Scientist responsible for applying GMP principles in late-stage development, performing analytical characterization of protein-based therapeutics, and supporting method development and transfers. You will maintain instrumentation, document results in ELNs, and train/oversee contract analytical staff to ensure robust and compliant analytical performance.

Responsibilities

• Apply phase-appropriate GMP principles to ensure compliance and high-quality documentation in support of late-stage development activities.
• Conduct in-depth analysis of late-stage protein-based therapeutics using analytical techniques including CE-SDS, HPLC/UPLC, HIAC, CIEF, CEX, SEC, HILIC, HIC, RP chromatography, spectrophotometry, and mass spectrometry.
• Support the development, optimization, and troubleshooting of separation-based purity methods; contribute to method qualifications, transfers, and validation studies to ensure robust analytical performance.
• Perform hands-on maintenance and troubleshooting of CE and LC instrumentation to ensure consistent operational performance.
• Use analytical data processing software (e.g., Empower) and electronic laboratory notebooks (ELNs) for documentation, protocol development, and report authorship.
• Provide training, troubleshooting support, and oversight of analytical workflows executed by Rapid Analytics contract staff.
• Monitor assay control charts to assess ongoing performance of analytical testing conducted by the Rapid Analytics team.

Qualifications

• Master’s degree (or foreign equivalent) in Food Science, Chemistry, Biochemistry, Biotechnology, or related field, plus completion of a university-level course, research project, internship, thesis, or one year of relevant experience in the following areas:
• Capillary electrophoresis (CE-SDS), HPLC/UPLC, MS, and chromatography methods including CEX, SEC, HILIC, HIC, and RP.
• Experience with CE and LC instruments, including maintenance, troubleshooting, and ensuring operational performance.
• Data processing software including Empower and experience with electronic laboratory notebooks (ELNs) for data documentation and analysis.
• Understanding of phase-appropriate GMP compliance and documentation practices; contribution to method qualifications and transfers in late-stage protein therapeutics development.
• Experience in providing training, troubleshooting support, and oversight of analytical workflows to ensure quality control.
• Experience with spectrophotometer-based spectroscopy (UV and fluorescence detectors).

Skills

• Analytical instrumentation operation and maintenance (CE, LC, MS).
• Analytical method development, qualification, transfers, and validation.
• Data analysis and documentation (Empower, ELNs).
• Training and oversight of contract analytical staff.
• Strong attention to GMP-compliant documentation and data integrity.
• Problem-solving and troubleshooting within analytical workflows.