Related skills
gxp glp ada lims sops📋 Description
- Lead scientist on ADA/PK assay development projects
- Lead assay validation and data generation
- Present data to clients and stakeholders
- Write validation plans and reports
- Ensure adherence to GLP standards
- Manage timelines and data integrity in milestone projects
🎯 Requirements
- BS in a related field + 6+ yrs lab exp; or MS with 4+ yrs; or PhD with 2+ yrs
- Experience developing immunoassays (ELISA, MSD-ECL, PK/ADA)
- Strong knowledge of GLP and GxP
- Experience with PK/biomarker/ADA assays or potency/NAb assays
- Proficient in MS Excel and Word; strong communication
- Supervisory experience leading teams
- Familiarity with LIMS and SOPs; study design experience
🎁 Benefits
- Medical, dental, and vision coverage
- Flexible Spending Account (FSA)
- Short/Long-term Disability
- 4 weeks PTO annually
- Parental leave; paid holidays
- 401k with employer match; Employee Referral Program
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