CMC Analytical Development Lead (Senior Manager)

Asahi Kasei Therapeutics, Inc.; Cary (NC); On-site; USD 150,000 - 160,000; Full time

Job summary

Asahi Kasei Therapeutics, Inc. is seeking an experienced analytical leader to oversee CMC testing and method development at CRO/CDO/CMOs. The role drives validation, transfers, and data review to support regulatory filings for our large molecule programs.

You will coordinate with partners, ensure compliance with GMP and ICH guidelines, and lead technical reviews of analytical data. A PhD/MS/BS in analytical chemistry and 10 years’ CMC experience are required.

Qualifications

• BS, MS or PhD in Analytical Chemistry, Biochemistry, or related field.
• 10 years' experience in CMC analytical in pharmaceutical testing environments.
• Extensive knowledge of development and validation of CMC analytical methods.
• Extensive knowledge of CMC analytical techniques (e.g., HPLC, ligand binding assays, capillary electrophoresis, CCIT, endotoxin, process impurity methods, peptide mapping, and mass spectrometry).
• Regulatory submissions knowledge for CMC development; this includes all analytical modules for drug substance and drug product (3.2.S and 3.2.P).
• Ability to transform CMC data into knowledge and present to stakeholders.

Responsibilities

• Oversees conduct of all CMC testing (large molecule) at CRO/CDO/CMOs.
• Oversees CMC method development, validation, qualification, and transfers at CRO/CDO/CMOs.
• Oversees CMC stability programs at CRO/CDO/CMOs.
• Provides expert review, assessment, and trending of CMC analytical data from CRO/CDO/CMOs.
• Oversees characterization, qualification, and life-cycle management of reference materials.
• Serves as technical lead for CMC analytical testing.
• Manages CMC methods and specifications for release and stability.
• Authors documentation to support regulatory filings (IND, IMPD, NDA/BLA, post-approval changes).
• Authors/reviews change controls, SOPs, and reports for multiple departments and partners.
• Stays abreast of scientific literature and regulatory guidelines relevant to CMC.

Skills

CMC analytical development

HPLC method development

Regulatory submissions support

Data analysis & interpretation

GMP/compliance

Education

BS/MS/PhD in Analytical Chemistry or Biochemistry

Tools

MS Office Suite

Adobe Acrobat Pro

Job description

Asahi Kasei Therapeutics, Inc. is seeking an experienced analytical leader to oversee CMC testing and method development at CRO/CDO/CMOs. The role drives validation, transfers, and data review to support regulatory filings for our large molecule programs.

You will coordinate with partners, ensure compliance with GMP and ICH guidelines, and lead technical reviews of analytical data. A PhD/MS/BS in analytical chemistry and 10 years’ CMC experience are required.