Senior Scientist II, Discovery Analytical Chemistry

Responsibilities

• Design, develop, optimize, qualify, and transfer analytical methods to support development and manufacturing activities.
• Lead analytical characterization studies for drug substances, intermediates, and related materials.
• Develop and execute analytical strategies to assess product identity, purity, potency, impurities, and stability.
• Interpret analytical data, investigate trends, and provide scientific recommendations to project teams.
• Support method lifecycle management, troubleshooting, and continuous improvement activities.
• Provide scientific and technical oversight of analytical development, testing, method qualification, and transfer activities conducted at CDMOs.
• Review protocols, reports, deviations, investigations, and technical documents generated by external partners.
• Monitor project timelines, deliverables, and analytical performance to ensure project objectives are achieved.
• Serve as the primary analytical subject matter expert during interactions with CDMOs and contract testing laboratories.
• Collaborate with Process Development, Manufacturing, Quality Control, Quality Assurance, Regulatory Affairs, and CMC teams to support program milestones.
• Contribute to analytical control strategy development and product specification setting.
• Present analytical findings and recommendations to internal teams and management.
• Author and review analytical sections of regulatory submissions, including INDs, IMPDs, CTAs, BLAs, and other global regulatory filings.
• Support responses to regulatory agency questions and inspections.
• Ensure analytical activities comply with applicable GMP, ICH, FDA, EMA, and other regulatory requirements.
• Participate in quality investigations, change controls, risk assessments, and CAPA activities as needed.

Requirements

• PhD in analytical chemistry or close related fields with 5+ years pharmaceutical relevant industry experience; or M.S. with 8+ years of relevant industry experience; or 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.
• Able 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.

Preferred

• Hands-on Experience with Size Exclusion Chromatography coupled with Multi-Angle Light Scattering (SEC-MALS) is preferred but not necessary.
• 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.