CMC Analytical Development Lead

Asahi Kasei Therapeutics; Cary (NC); Hybrid; USD 150,000 - 160,000; Full time

Job summary

Asahi Kasei Therapeutics seeks a senior professional to provide analytical leadership for the Company’s CMC portfolio, driving testing, method development, and regulatory documentation through CRO/CDO/CMO partnerships. You will manage qualification/validation, stability programs, and data review to ensure compliance with GMP and ICH guidelines.

The role emphasizes cross-functional collaboration with Regulatory, Manufacturing, and Quality Assurance, as well as preparation for regulatory

Qualifications

• Advanced degree in analytical chemistry or related field with relevant pharmaceutical experience.
• Strong background in CMC analytical development and regulatory context.

Responsibilities

• Oversees conduct of all CMC testing at CRO/CDO/CMOs.
• Oversees CMC method development, validation, qualification, and transfers at CRO/CDO/CMOs.
• Oversees CMC stability programs at CRO/CDO/CMOs.
• Reviews and trends CMC analytical data from CRO/CDO/CMOs.
• Leads technical aspects of CMC analytical testing and transfer.
• Ensures documentation for regulatory filings (IND/IMPD/NDA/BLA).
• Supports regulatory inspections and interactions with partners.

Skills

Analytical Chemistry

CMC analytics

HPLC

Mass spectrometry

Capillary electrophoresis

Regulatory submissions

ICH guidelines

Data analysis

GMP/Data integrity

Project management

Communication

MS Office

Travel readiness

Education

BS/MS/PhD in Analytical Chemistry

Tools

HPLC

Mass spectrometry

Capillary electrophoresis

CMC testing equipment

Job description

Asahi Kasei Therapeutics seeks a senior professional to provide analytical leadership for the Company’s CMC portfolio, driving testing, method development, and regulatory documentation through CRO/CDO/CMO partnerships. You will manage qualification/validation, stability programs, and data review to ensure compliance with GMP and ICH guidelines.

The role emphasizes cross-functional collaboration with Regulatory, Manufacturing, and Quality Assurance, as well as preparation for regulatory