Sr. Manager, CMC Analytical Development

Job Description

This position provides analytical support of the Company’s product portfolio and pipeline from early-stage development through post-approval requirements. The incumbent works directly with company partners to ensure testing complies with Quality, Regulatory, and Company requirements and collaborates with CRO/CDO/CMO partners on study activities to meet established timelines.

• Oversees conduct of all CMC testing (large molecule) at CRO/CDO/CMOs.
• Oversees CMC method (large molecule) 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.
• Communicates project tasks, deliverables, and timelines to external partners, ensuring critical deadlines are met.
• Authors relevant documentation to support regulatory filings (IND, IMPD, NDA/BLA, post‑approval changes).
• Authors, reviews, and/or approves protocols, SOPs, change controls, and reports, ensuring delivery to Company departments and external vendors.
• Supports partners in all activities related to CMC analytical development.
• Assists in the department’s efficient execution of departmental/area goals.
• Supports the Quality Assurance department in auditing activities of CRO/CDO/CMOs.
• Prepares for regulatory agency inspections, including pre‑approval inspections of Company and contractor facilities.
• Stays abreast of scientific literature and regulatory guidelines pertinent to CMC analytical development and therapeutic areas.

• BS, MS or PhD in Analytical Chemistry, Biochemistry, or related field.
• 10 years of experience in CMC analytical in pharmaceutical testing environments.
• Extensive knowledge of development, validation, and qualification of CMC analytical methods.
• Extensive knowledge of CMC analytical techniques (HPLC, ligand binding assays, capillary electrophoresis, CCIT, endotoxin, process impurity methods, peptide mapping, and mass spectrometry).
• Demonstrated expertise in troubleshooting and resolving CMC‑related laboratory investigations and deviations.
• Knowledge of regulatory submission requirements for CMC development, including analytical modules for drug substance and drug product (3.2.S and 3.2.P).
• Ability to analyze and transform CMC data (release and stability) into actionable knowledge.
• Extensive knowledge of ICH, market‑specific guidance, national pharmacopoeia, and industry work groups.
• Demonstrated ability to assess and act on programs of work to meet business goals.
• Proficiency in quality procedures (GMPs, including data integrity).
• Consistent application of scientific/technical concepts to resolve issues efficiently and effectively.
• Efficient time management, capable of multi‑tasking and prioritization; structured and proactive work approach.
• Excellent interpersonal and communication skills (verbal, written, presentation) to both internal and external audiences.
• Proficiency in MS Office Suite (Outlook, Excel, Word, PowerPoint) and Adobe Pro.

Base compensation range for this role is $150,000‑$160,000, influenced by experience, skills, performance, and business conditions. The package includes health and insurance benefits, training, development opportunities, and performance‑based bonus eligibility.

Approximately 30% travel.

Asahi Kasei believes a diverse workforce provides the ability to continuously support changes in society, economy, and environment. We are an equal opportunity employer.