Scientist - Reference Standards Qualification

Role: Sr. Scientist – Reference Standards Qualification Responsibilities: Support lifecycle management of reference standards, assay controls, and critical reagents through qualification, stability monitoring, and technical assessments. Author and review GMP and regulatory documents such as protocols, reports, and Certificates of Analysis. Monitor analytical method performance via data trending and collaborate with internal teams and external partners to ensure timely execution of activities. Qualifications & Skills: Bachelor's degree in a lab sciences field; 2+ years (Master's) or 4+ years (Bachelor's) experience in analytical lifecycle management. Knowledge of ICH, GMP, and regulatory guidelines; experience with biological products, reference standard qualification, and analytical techniques like immunoassays and molecular biology. Strong technical writing, data analysis, and interpretation skills. Experience supporting cell and gene therapy, biologics, or CRISPR programs is preferred. Skills: Ability to prioritize, work in a lab setting with hazardous elements, and communicate effectively with diverse groups. Proficiency with statistical tools and laboratory equipment. Capable of handling multiple projects and working under pressure. Work Environment: Onsite role in a laboratory setting, adhering to GMP safety standards. Physical ability to lift up to 25 pounds and work upright or standing for periods. Flexibility to work in non-traditional environments and handle potentially hazardous materials. This full-time position offers competitive compensation, benefits, and career development opportunities. The salary range is estimated at $95,000–$100,100, with potential bonuses and comprehensive employee benefits including health plans, paid time off, retirement plans, and stock purchase options.