Senior Analytical Development Lead | Strategy & CMC Expert

Otsuka Pharmaceutical Co., Ltd; Northern (KY); Hybrid; USD 135,000 - 201,000; Full time

Benefits offered by this job

Comprehensive benefits package

401(k) match

Paid holidays and leave

Job summary

Otsuka Pharmaceutical Co., Ltd. seeks a senior analytical leader to oversee strategy and technical analytics across third party labs. The role drives method development, validation, and transfer for small molecules and peptides, ensuring GMP/GxP compliance and alignment with regulatory expectations.

You will collaborate across regulatory affairs, QA, and development teams to resolve complex issues, mentor staff, and deliver scientific insights that advance IND/NDAs and clinical milestones.

Qualifications

• Requires PhD or MSc with substantial pharma analytics experience in a GXP environment.
• Demonstrated leadership, communication, and stakeholder management skills.
• Experience with regulatory requirements and quality standards in drug development.

Responsibilities

• Lead analytical strategy and lab testing across CRO/CT labs.
• Develop/validate/transfer analytic methods for small molecules and peptides.
• Provide regulatory support and compile CMC sections.
• Mentor team members and ensure compliance with timelines and quality standards.

Skills

Analytical leadership

Regulatory communication

Cross-functional collaboration

MS Office/Excel

Mass spectrometry (MS)

Data review

GXP compliance

Education

PhD in analytical science/chemistry

Bachelor’s or Master’s in analytical science/chemistry

Tools

Mass spectrometry (MS)

MS Office (Excel)

Job description

Otsuka Pharmaceutical Co., Ltd. seeks a senior analytical leader to oversee strategy and technical analytics across third party labs. The role drives method development, validation, and transfer for small molecules and peptides, ensuring GMP/GxP compliance and alignment with regulatory expectations.

You will collaborate across regulatory affairs, QA, and development teams to resolve complex issues, mentor staff, and deliver scientific insights that advance IND/NDAs and clinical milestones.