PLS Scientist 3 - BioPharma
$80,000–$90,000 year
On-site · Oakdale, Minnesota, United States
Job Summary
Lead the design, optimization, and qualification/validation of analytical methods for biopharmaceutical drug substances and drug products (including peptides, oligos, proteins, mAbs), serving as a bioanalytical technical expert for ELISA, plate-based assays, SDS-PAGE, cell-based assays, qPCR, ddPCR, Sanger Sequencing, CE, and cIEF. Develop strategy aligned with ICH Q2(R2) and evolving regulatory expectations for biologics; stay current with ICH/USP/EP; author/review method development reports, validation protocols/reports, and lab methods. Provide scientific leadership during investigations, troubleshooting, and method lifecycle management; mentor junior scientists; present data to client organizations and collaborate cross-functionally.
Required Qualifications
- Bachelor's degree in Chemistry, Biochemistry, Analytical Chemistry, or a related scientific discipline with 8-10 years of relevant laboratory experience
- Master’s Degree in Chemistry, Biochemistry, Analytical Chemistry, or a related scientific discipline with 4-7 years of relevant laboratory experience
- Ph.D. in Chemistry, Biochemistry, Analytical Chemistry, or a related scientific discipline with 1-4 years of relevant laboratory experience
- Demonstrated expertise in bioanalytical method development and validation for biologics
- Strong hands-on experience with key biopharmaceutical analytical platforms
- Familiarity with GMP, ICH guidelines, and regulatory expectations for biologics
- Excellent technical writing skills and experience
- Strong communication, leadership, and project management capabilities
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