Senior Scientist I, Potency and Impurities

The Role
- Serve as subject matter expert for potency and immunoassays for early stage biotherapeutics across multiple platforms
- Perform method development, qualification, and routine sample testing
- Apply knowledge of ICH, FDA, EMA, and USP guidelines relevant to analytical testing
- Participate in process development teams; may serve as analytical team lead and interface with internal teams and external clients
- Author and review technical documents including methods, qualification/development reports, and SOPs
- Present data to internal teams, clients, and at industry conferences
- Lead cross-functional teams and initiatives and junior team members
- Ensure lab equipment maintenance/calibration; oversee reagent and consumable management
- Contribute to continuous improvement to enhance throughput, robustness, and compliance

Who You Are (Qualifications)
- PhD with 3+ years relevant industry experience, or BS with 10+ years; degree in Biochemistry, Biology, Bioengineering, or related field
- Immunoassay method development and qualification experience
- GMP Testing experience
- Comprehensive knowledge of ICH/USP guidelines on analytical and potency methods
- Excellent communication skills; cross-functional work in a fast-paced CDMO environment
- Strong organizational skills; manage multiple priorities and meet deadlines

Additional Qualifications (Preferred)
- Experience with SoftMax Pro, JMP, Microsoft Office, ELN
- Experience developing BLI or SPR methods
- Knowledge of impurity methods for biotherapeutics
- Experience with compendial method testing

Application Instructions
- Apply today.