Sr. Manager, CMC Analytical Development

Overview

The Asahi Kasei Group operates with a commitment to creating for tomorrow. Veloxis Pharmaceuticals is an Asahi-Kasei Group Company based in Cary, NC. Veloxis focuses on transforming transplant medicine by partnering with the transplant healthcare community and patients, developing new therapies and programs to assist providers and patients. The company offers a dynamic and collaborative environment with opportunities for professional development and a competitive compensation package including health and insurance benefits, training, and performance-based bonus eligibility.

Summary of the position:
This role provides analytical support for the Company’s product portfolio and pipeline from early-stage development through post-approval requirements. It involves working with partners to ensure testing complies with Quality, Regulatory, and Company requirements, managing multiple projects, and providing scientific oversight for outsourced work related to method development, qualification/validation, sample analysis, characterization, data delivery, and reporting.

The base compensation range for this role is $150-160K and is influenced by factors such as tenure, experience, skills, performance, and business conditions.

• 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, ensuring deadlines are met.
• Authors appropriate documentation to support regulatory filings (IND, IMPD, NDA/BLA, and pre/post-approval changes).
• Authors, reviews, and/or approves technical protocols, SOPs, change controls, and reports, ensuring delivery to Manufacturing & Technical Operations, Clinical, Quality Assurance, Regulatory Affairs, external vendors, and/or license partners.
• 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, including pre-approval inspections at Company facilities and key contractors’ facilities.
• Stays abreast of scientific literature and regulatory guidelines pertinent to CMC analytical development and the therapeutic areas of the Company’s products.

• 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 and 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 regulatory submission requirements for CMC development; this includes all 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 knowledge.
• Extensive knowledge of ICH, pharmacopoeias, and industry groups related to CMC analytical development.
• Ability to assess and act on programs of work to meet business goals.
• Proficiency in quality procedures (e.g., GMPs, data integrity).
• Strong scientific/technical problem-solving skills with proven execution capability.
• Effective time management, multitasking, and prioritization; proactive work approach.
• Excellent interpersonal and communication skills; ability to present to internal and external audiences.
• Proficiency in MS Office Suite (Outlook, Excel, Word, PowerPoint) and Adobe Pro.
• Travel:
  Approximately 30%

As an equal opportunity employer, Asahi Kasei believes a diverse workforce will provide the company with the ability to support changes in the economy, society, and environment.