Scientist I, Analytical Sciences

Job Responsibilities

• Conduct assay development, transfer, optimization, assessment, and routine testing for ELISA-based assays, PCR-based assays, and cell-based assays.
• Design and execute experiments to develop, optimize, and troubleshoot analytical methods for biologics characterization.
• Generate, analyze, and document data with high scientific rigor, ensuring accuracy and compliance to quality standards.
• Interpret analytical data and provide scientific insights to support process development and product understanding.
• Lead iCMC and standalone analytical projects as Analytical Sciences Function Lead, including client communication, cross-team communication, analytical strategy development, method selection, and project execution.
• Collaborate with cross-functional teams (PD, MFG, QC, MSAT) to support project deliverables.
• Support lab operations including lab equipment maintenance, lab cleaning and organization, reagent preparation, and inventory management.
• Utilize electronic systems or analytical software tools for data documentation and analysis.
• Trained on GMP practices and support GMP activities on a need basis.
• May be required to work on weekends or during off hours.

Qualifications

• Bachelor’s degree in Analytical Chemistry, Biochemistry, or related field with a minimum of 4 years of industry analytical development or quality control experience.
• Or Master’s degree in Analytical Chemistry, Biochemistry, or related field with a minimum of 2 years of industry analytical development or quality control experience.
• Hands-on experience with qPCR-based, ELISA-based assay is required.
• Hands-on experience with cell-based assay is required.
• Knowledge on HPLC-based assays, CE-SDS, UV-Vis Spectroscopy and iCIEF is preferred.
• Knowledge on drug life cycle management is prefered.
• Strong data analysis, organizational, and documentation skills.
• Strong communication and presentation skills.
• A minimum of two years of hands-on experience in qPCR-based, and ELISA-based assay.
• A minimum of one year of hands-on experience in cell-based assay.
• Knowledge in PCR-based, ELISA-based assay principles.
• Knowledge in mammalian cell culture and cell-based assay.
• Understanding of antibody and protein structural characteristics.
• Knowledge in large molecule drug development and life cycle management is preferred.

Soft Skills - Behavioral Competencies

• Ability to adapt to fast-pace working environment.
• Ability to adapt to frequent shift in responsibilities.
• Good communication and ability to work in a team-oriented environment.
• Able to be organized and keep positive attitude in high-stress working environment.

Pay

The anticipated salary range for this position is $60,200-96,300.