Sr. Manager, CMC Analytical Development

Veloxis Pharmaceuticals, an Asahi Kasei Group company based in Cary, NC, is focused on transforming transplant medicine as the primary partner to transplant healthcare providers and their patients. We develop new therapies and programs to support this community, offering a dynamic, innovative, and patient-centric workplace that values professional development, diversity, and collaboration.

About the role

This position provides analytical support for the company’s product portfolio and pipeline—from early-stage development through post-approval requirements—while working directly with partners to ensure testing complies with Quality, Regulatory, and Company standards. The role involves high levels of external communication, project management, and scientific oversight of outsourced activities, including method development, validation, sample analysis, and reporting.

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 documentation to support regulatory filings (e.g., IND, IMPD, NDA/BLA, pre- and post-approval changes).
• Authors, reviews, and/or approves technical protocols, SOPs, change controls, and reports for internal departments, external vendors, and license partners.
• Supports partners in CMC analytical development activities.
• Assists in executing departmental and area goals efficiently.
• Supports Quality Assurance in auditing CRO/CDO/CMOs.
• Prepares for regulatory agency inspections, including pre-approval inspections at company and contractor facilities.
• Stays current with scientific literature and regulatory guidelines related to CMC analytical development and therapeutic areas.

Requirements

• BS, MS, or PhD in Analytical Chemistry, Biochemistry, or a related field.
• 10+ years of experience in CMC analytical work within pharmaceutical testing environments.
• Extensive knowledge of CMC analytical method development and validation.
• Proficiency in CMC analytical techniques (e.g., HPLC, ligand binding assays, capillary electrophoresis, CCIT, endotoxin testing, process impurity methods, peptide mapping, mass spectrometry).
• Demonstrated expertise in troubleshooting and resolving CMC-related laboratory investigations and deviations.
• Knowledge of regulatory submission requirements and strategies for CMC development, including analytical modules for drug substance and drug product (3.2.S and 3.2.P).
• Ability to analyze and interpret CMC data (release and stability) to drive decision-making.
• Extensive knowledge of ICH guidelines, market-specific regulations, national pharmacopoeia, and industry workgroups related to CMC analytical development.
• Ability to assess and act on work programs to meet business goals.
• Proficiency in Quality procedures (e.g., GMPs, including data integrity).
• Consistency in applying and advancing scientific/technical concepts to resolve issues efficiently.
• Strong time management, multitasking, and prioritization skills; structured and proactive work approach.
• Excellent interpersonal, communication (verbal and written), and presentation skills for internal and external audiences.
• Proficiency in MS Office Suite (Outlook, Excel, Word, PowerPoint) and Adobe Pro.

Pay

The base compensation range for this role is $150,000–$160,000, influenced by factors such as time in the role, previous experience, skills, knowledge, performance, work requirements, internal equity, and business/economic conditions.

Schedule

Hybrid work arrangement with approximately 30% travel required.