Senior Scientist II, Discovery Analytical Chemistry
$130,000–$150,000 year
On-siteMadison, Wisconsin, United States
Job Summary
Design, develop, optimize, qualify, and transfer analytical methods to support pharmaceutical development and manufacturing activities. Lead characterization studies for drug substances, intermediates, and related materials, while executing strategies to assess product identity, purity, potency, impurities, and stability. Provide technical oversight of analytical development and testing at CDMOs, reviewing protocols and documents to ensure compliance with GMP, ICH, FDA, and EMA requirements. Author regulatory submission sections and support agency responses. Collaborate with Process Development, Manufacturing, Quality, and Regulatory teams to drive project milestones and control strategy development.
Required Qualifications
- PhD in analytical chemistry or close related fields with 5+ years pharmaceutical relevant industry experience
- M.S. with 8+ years of relevant industry experience
- B.S. with 10+ years of relevant industry experience
- Extensive knowledge of Oligo, mAb, ADC or AOC-related analytical techniques and applications
- Demonstrated expertise with chromatographic methods, including HPLC, UHPLC, and related analytical platforms
- Experience with GMP-regulated analytical development and testing environments
- Strong understanding of method transfer, validation, and lifecycle management principles
- Experience authoring analytical CMC documentation for regulatory submissions
- Strong scientific problem-solving and troubleshooting skills
- Excellent technical writing and communication abilities
- Ability to manage multiple projects in a fast-paced environment
- Strong organizational skills and attention to detail
- Effective collaborator with demonstrated ability to influence cross-functional teams and external partners
- Candidates must have current, valid authorization to work in the country where this role is located
Desired Qualifications
- Hands-on Experience with Size Exclusion Chromatography coupled with Multi-Angle Light Scattering (SEC-MALS)
- Experience supporting biologics, oligonucleotides, ADC, AOC or other complex modalities
- Prior experience managing external laboratories and CDMOs
- Familiarity with ICH guidelines and global regulatory expectations
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