Sr. Manager, CMC Analytical Development

NCBiotech; Cary (NC); Hybrid; USD 150,000 - 160,000; Part time

Job summary

Veloxis Pharmaceuticals, Inc. in Cary, NC, seeks an experienced CMC analytic leader to oversee testing, method development, validation, and data review across CRO/CDO/CMOs in a collaborative hybrid environment.

The role drives regulatory filings support (IND/NDA/BLA) and ensures timely delivery of analytical data, trends, and quality standards, working with cross-functional partners to meet project timelines and product development goals.

Qualifications

• BS/MS/PhD in Analytical Chemistry, Biochemistry, or related field.
• 10+ years in CMC analytical in pharmaceutical testing environments.
• Knowledge of development/validation of CMC analytical methods.
• Proficiency with various CMC analytical techniques (HPLC, mass spectrometry, etc.).
• Ability to troubleshoot and resolve CMC lab investigations and deviations.
• Familiarity with regulatory submissions for CMC (3.2.S/3.2.P).
• Ability to transform CMC data into actionable knowledge.
• Knowledge of ICH/guidance and pharmacopoeia related to CMC.
• Experience with GMP/data integrity.
• Strong time management and communication skills.

Responsibilities

• Oversee conduct of CMC testing (large molecule) at CRO/CDO/CMOs.
• Lead CMC method development, validation, qualification and transfers at CRO/CDO/CMOs.
• Manage CMC stability programs at CRO/CDO/CMOs.
• Review and trend CMC analytical data from CRO/CDO/CMOs.
• Lead reference materials lifecycle management and characterization.
• Serve as technical lead for CMC analytical testing.
• Manage CMC methods and release/stability specifications.
• Communicate tasks and timelines with external partners to meet deadlines.
• Prepare regulatory documentation (IND, IMPD, NDA/BLA) and changes.
• Prepare and review protocols, SOPs, change controls, and reports.
• Support partners in CMC analytical development activities.
• Assist in achieving departmental goals and audits.
• Support QA in auditing CRO/CDO/CMOs.
• Prepare for regulatory inspections at company facilities and contractors.
• Stay current with literature and regulatory guidelines.

Skills

CMC analytics experience

CMC method validation

CMC analytical techniques

Troubleshooting CMC labs

CMC regulatory filings

CMC data analysis

ICH guidance

GMP compliance

Multitasking

Communication skills

Education

BS/MS/PhD in Analytical Chemistry or Biochemistry

Tools

MS Office Suite

Adobe Pro

Job description

The Asahi Kasei Group operates with a commitment of creating for tomorrow. Our business sectors, Material, Homes, and Health Care, contribute to the development of society by anticipating the changing needs of those around the world. We look for candidates that offer a fresh perspective and a variety of skills to help us achieve our commitment.

Veloxis Pharmaceuticals is an Asahi-Kasei Group Company based in Cary, NC. Our purpose is to transform transplant medicine as the primary partner to the community of transplant healthcare providers and their patients; our focus is in developing new therapies and programs to help transplant healthcare providers and the patients they treat. Veloxis provides a dynamic and innovative place to work that encourages professional development and embraces diversity. We seek creative, intelligent, action-oriented, and passionate individuals who thrive in a collaborative team environment. If you are interested in being part of a patient-centric company, then we invite you to learn more about the employment opportunities available at Veloxis. Our success is tied to the contribution of every team member, which is why we provide a valuable and competitive compensation package that includes health and insurance benefits, training, and development opportunities, as well as performance-based bonus eligibility.

Company:

Veloxis Pharmaceuticals, Inc.

Job Description:

This position provides analytical support of the Company’s product portfolio and pipeline from early-stage development through post-approval requirements and works directly with the Company’s partners to ensure testing is compliant with Quality, Regulatory, and Company requirements, necessitating a high level of external communication and interaction as well as ability to manage multiple projects. The incumbent works on project teams to drive the growth and development the Company’s products, as well as with contract research/development/manufacturing organization (CRO/CDO/CMO) partners on study activities to meet established timelines and provide necessary scientific oversight for outsourced work on method development/re-development, qualification/validation, sample analysis, characterization, data delivery, and reporting.

The base compensation range for this role is $150-160K. Base Compensation is influenced by many factors including, but not limited to: time in the role, previous experience, skills, knowledge, performance, work requirements, internal equity, and business / economic conditions.”

Summary Of 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.
• Efficiently communicates project tasks, deliverables, and timelines to external partners, ensuring that critical deadlines are agreed upon and met.
• 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, ensuring delivery of those reports to other Company departments (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 the Company’s facilities and key contractors’ facilities.
• Stays abreast of scientific literature and regulatory guidelines pertinent to CMC analytical development and the therapeutic area(s) of the Company’s products.

Required Qualifications And Skills

• 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.
• Travel Requirements: Approximately 30%

Hybrid

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