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.
• The salary range for this role is $117,000.00 - $184,200.00; The successful candidate will be eligible for annual bonus and long-term incentive, if applicable; We offer a comprehensive package of benefits.

Matching Summary

Salary

Base: $117,000.00 - $184,200.00; Bonus/Equity: Eligible for annual bonus and long-term incentive; Benefits: Comprehensive package including medical, dental, vision, retirement, 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 LIMS, Empower, electronic notebooks
• Knowledge of cGxP, USP, EP, ICH, and FDA guidelines

Work Rights