Senior Manager, Analytical Development - Small Molecules

Otsuka Pharmaceutical Co., Ltd.; United States; À distance; USD 135 000 - 201 000; Plein temps

Avantages offerts par ce poste

Medical, dental, vision coverage

Life and disability insurance

401(k) match

Paid leave & holidays

Résumé du poste

Otsuka Pharmaceutical Co., Ltd. in the United States seeks a senior analytical leader to oversee analytical activities at third-party laboratories, develop/validate/transfer methods, and support stability and regulatory filings across early to late-stage drug development for small molecules, peptides, and related modalities.

This role partners with R&D, regulatory, quality, and CMC teams to ensure compliance, drive scientific excellence, and deliver actionable insights.

Qualifications

• Must have advanced degree in analytical science or chemistry with extensive experience in analytical testing of pharmaceuticals in a GXP environment.
• Experience leading method development, validation, transfer, and stability testing in CRO/CMO settings.
• Strong written and oral communication skills with ability to author technical reports and CMC sections.

Responsabilités

• Oversee analytical activities at third-party laboratories, including method development/validation/qualification, stability testing, and regulatory support.
• Collaborate cross-functionally with R&D, regulatory affairs, QA, and other departments to drive scientific excellence and compliance.
• Lead method development, optimization, and transfer for synthetic small molecules testing at contract labs.
• Provide actionable insights to optimize project outputs, monitor progress, mitigate risks, and align with strategic objectives.
• Develop and implement analytical strategies aligned with regulatory requirements and industry best practices.
• Provide analytical data to support drug substance and product development, including purity analysis and structure elucidation using MS.
• Manage stability studies for IND/NDA activities and ensure regulatory compliance.
• Author technical reports and CMC sections; mentor and train team members.

Connaissances

Leadership

Communication

Regulatory knowledge

GXP experience

Data review

Cross-functional collaboration

Formation

Bachelor’s or Master’s degree in analytical science, chemistry or related science

PhD in analytical science, chemistry or related science

Outils

MS Excel

MS Office

Description du poste

Otsuka Pharmaceutical Co., Ltd. in the United States seeks a senior analytical leader to oversee analytical activities at third-party laboratories, develop/validate/transfer methods, and support stability and regulatory filings across early to late-stage drug development for small molecules, peptides, and related modalities.

This role partners with R&D, regulatory, quality, and CMC teams to ensure compliance, drive scientific excellence, and deliver actionable insights.