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. Key Responsibilities 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. Required Qualifications and Skills 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 workgroups. 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. Compensation and Benefits 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. Travel Requirements Approximately 30% travel. Equal Opportunity Employer Asahi Kasei believes a diverse workforce provides the ability to continuously support changes in society, economy, and environment. We are an equal opportunity employer. #J-18808-Ljbffr Veloxis Pharmaceuticals, Inc.