Strategic Leader, Global Analytical Development & QC

Otsuka Pharmaceutical Co., Ltd.; United States; Remote; USD 231,000 - 345,000; Full time

Benefits offered by this job

Comprehensive medical

Dental coverage

Vision coverage

Prescription drug coverage

401(k) match

Tuition reimbursement

Paid holidays

Paid leave programs

Job summary

Otsuka Pharmaceutical Co., Ltd. is seeking a Senior Director of Analytical Development & QC (Small Molecules) to lead strategic and operational analytical efforts across drug substance and product development, clinical supply, and lifecycle management.

The role partners with Process Development, Manufacturing, Quality, and Regulatory Affairs, guiding external CDMOs and CROs while driving data integrity and regulatory readiness for filings and inspections.

Qualifications

• PhD in Analytical Chemistry, Biochemistry, Pharmaceutical Sciences, or related field.
• 15+ years of experience in analytical development and/or QC within biopharmaceutical or pharmaceutical industry.
• 7+ years in people leadership roles with experience building and scaling teams.
• Direct experience supporting late-stage development and commercial products; strong regulatory submission track record.

Responsibilities

• Define and execute analytical development and QC strategy across lifecycle.
• Lead method development, qualification, validation, and transfer for drug substances and products.
• Oversee QC testing labs, ensure cGMP compliance, data integrity, and CAPA implementation.
• Author and review analytical sections of regulatory submissions (INDs, NDAs, BLAs, MAAs).
• Lead CRO/CMO external partnerships with governance and performance metrics.

Skills

Analytical development

QC oversight

Regulatory interactions

People leadership

CMC collaboration

External partnerships

Budget management

Education

PhD in Analytical Chemistry, Biochemistry, Pharmaceutical Sciences, or related

Job description

Otsuka Pharmaceutical Co., Ltd. is seeking a Senior Director of Analytical Development & QC (Small Molecules) to lead strategic and operational analytical efforts across drug substance and product development, clinical supply, and lifecycle management.

The role partners with Process Development, Manufacturing, Quality, and Regulatory Affairs, guiding external CDMOs and CROs while driving data integrity and regulatory readiness for filings and inspections.