Senior CMC Analytical Development Lead

Pharmaceutical Compliance Forum Inc; Cary, Northern (NC, KY); Hybrid; USD 150,000 - 160,000; Full time

Job summary

Veloxis Pharmaceuticals, Inc. in Cary, NC seeks a Sr. Manager, CMC Analytical Development to lead all CMC testing and method development across CRO/CDO/CMO partners. The role ensures compliance with quality, regulatory, and company standards while guiding multiple projects end-to-end.

The position requires 10 years in CMC analytics, extensive GMP knowledge, and strong collaboration with regulatory affairs, manufacturing, and QA to support IND/NDA submissions and inspections.

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 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.

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.
• Communicates project tasks, deliverables, and timelines to external partners.
• Authors documentation to support regulatory filings (IND, IMPD, NDA/BLA).
• Supports partners in activities related to CMC analytical development.
• Prepares for regulatory inspections at company facilities and contractors.
• Stays abreast of scientific literature and regulatory guidelines.

Skills

CMC analytical development

HPLC

Mass spectrometry

Peptide mapping

Capillary electrophoresis

Data integrity

Regulatory submissions

GMP

Troubleshooting

Communication

Education

BS/MS/PhD in Analytical Chemistry or related field

Tools

MS Office

Adobe Pro

Job description

Veloxis Pharmaceuticals, Inc. in Cary, NC seeks a Sr. Manager, CMC Analytical Development to lead all CMC testing and method development across CRO/CDO/CMO partners. The role ensures compliance with quality, regulatory, and company standards while guiding multiple projects end-to-end.

The position requires 10 years in CMC analytics, extensive GMP knowledge, and strong collaboration with regulatory affairs, manufacturing, and QA to support IND/NDA submissions and inspections.