Senior Manager, CMC Analytical Development

Asahi Kasei

Provides analytical support for CMC product development and oversees testing compliance at Veloxis Pharmaceuticals. Works with partners to drive product pipeline from development through post-approval requirements.

Posted 7/10/2026full-timeCary • North Carolina • 🇺🇸 United StatesSenior💰 $150,000 - $160,000 per yearWebsite

About the role

Key responsibilities & impact

Provides analytical support of the Company’s product portfolio and pipeline from early-stage development through post-approval requirements
Works directly with the Company’s partners to ensure testing is compliant with Quality, Regulatory, and Company requirements
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
Efficiently communicates project tasks, deliverables, and timelines to external partners
Authors appropriate documentation in a timely manner to support regulatory filings, including but not limited to IND, IMPD, NDA/BLA, and pre- and post-approval changes
Authors, reviews, and/or approves all technical related protocols, SOPs, change controls, and reports, as needed
Supports partners in all activities related to CMC analytical development
Assists in the department’s successful and efficient execution of departmental/area goals
Supports the Quality Assurance department in auditing activities of CRO/CDO/CMOs
Prepares for regulatory agency inspections

Requirements

What you’ll need

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 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)
Demonstrated expertise in troubleshooting and resolution of CMC related laboratory investigations and deviations
Knowledge of requirements and strategy for regulatory submissions related to CMC development; this includes all analytical modules for drug substance and drug product (3.2.S and 3.2.P)
Demonstrated ability to analyze and transform CMC data (release and stability) into knowledge
Extensive knowledge of ICH, market specific guidance, national pharmacopoeia, and industry workgroups related to CMC analytical development
Demonstrated ability to assess and act on programs of work to meet business goals
Proficiency in Quality procedures (e.g., GMPs, including data integrity)
Demonstrated consistency in applying and furthering scientific/technical concepts and techniques to resolve scientific/technical issues efficiently and effectively
Efficient time management, capable of multi-tasking and prioritization; structured and proactive work approach
Excellent interpersonal and communication (verbal and written); effective presentation skills to both internal and external audiences
Proficiency in MS Office Suite (Outlook, Excel, Word, PowerPoint) and Adobe Pro.

Benefits

Comp & perks

health and insurance benefits
training and development opportunities
performance-based bonus eligibility

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

CMC Analytical TechniquesMethod ValidationRegulatory Filings (IND, NDA/BLA)Troubleshooting Laboratory InvestigationsData AnalysisStability Programs ManagementCharacterization of Reference MaterialsAnalytical Protocols and SOPsQuality Assurance AuditingCMC Specifications Management

Soft Skills

Excellent Communication SkillsInterpersonal SkillsTime ManagementMulti-taskingProactive Work Approach