Job Summary

• The role involves developing and performing analytical methods for raw materials testing, authoring and maintaining Standard Operating Procedures (SOPs), supporting instrument qualification, and collaborating with production for timely, compliant raw material release for clinical batch production.
• The incumbent will work with stakeholders such as Technical Operations, Manufacturing, Analytical Development, Large Molecule Assay Validation, Quality Assurance, and CMC Regulatory Affairs to solve technical issues, offer scientific guidance throughout development, and manage deliverables to advance the pipeline.
• We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days.

Matching Summary

Salary

Base: $117,000.00 - $184,200.00; Bonus/Equity: Annual bonus and long-term incentive, if applicable; Benefits: Medical, dental, vision, 401(k), paid holidays, vacation, sick days

Skills & Requirements

Key Requirements

• Ph.D. or M.S. with 3 years experience or B.S. with 7 years experience
• Knowledge of biologics manufacturing materials
• Proficient in spectroscopy and compendial methods
• Experience with GMP and data integrity principles

Work Rights