Sr. Manager, Manufacturing Sciences & Technology

About the role

Veloxis Pharmaceuticals, an Asahi‑Kasei Group Company based in Cary, NC, focuses on transforming transplant medicine by developing new therapies and programs for transplant healthcare providers and their patients. The company offers a dynamic, innovative workplace that encourages professional development and embraces diversity. The Senior Manager, Manufacturing Sciences & Technology (MS&T) role is based in Cary, NC with regular on‑site presence at the U.S.-based CDMO partner, and involves 30‑40% domestic and international travel in a hybrid work arrangement.

Responsibilities

• Serve as the MS&T Product Lead for the commercial small molecule product throughout its lifecycle, including its expanding portfolio of scales, suites, and line extensions.
• Serve as MTO lead for all inspection readiness and actual inspection activities for the Company.
• Develop and execute manufacturing science strategies supporting a high-volume commercial program (100+ batches per year), supply continuity, regulatory compliance, and operational excellence.
• Provide advanced technical leadership supporting commercial manufacturing campaigns, parallel scale changes, and new manufacturing suite start‑ups at the CDMO.
• Ensure manufacturing processes remain robust, compliant, validated, and inspection ready, with particular attention to coating uniformity and dissolution performance.
• Drive continuous improvement initiatives focused on process capability, manufacturing reliability, product quality, and operational efficiency across a high‑throughput program.
• Lead process development activities as needed for new scales, suites, or line extensions, including pre‑PPQ technical ownership where a dedicated Process Development lead has not yet been assigned.
• Lead execution of process validation and PPQ studies for new scales and suites, and own the process technically upon PPQ completion.
• Own CPV strategy, execution, and data trending across the commercial program, with emphasis on coating, dissolution‑related process parameters and inspection performance.
• Lead manufacturing investigations, deviations, CAPAs, and change controls, and lead troubleshooting of complex technical issues related to coating, dissolution, and other critical quality attributes.
• Lead implementation of process, scale, equipment, and site changes across parallel initiatives while maintaining validated process performance.
• Partner closely with Process Development to ensure successful transfer of process knowledge and scientific understanding into manufacturing for new scales and suites.
• Responsible for ensuring all process history is properly documented.
• Collaborate with Quality Assurance to ensure manufacturing compliance, deviation management, investigations, CAPAs, and inspection readiness.
• Work closely with Quality Control to ensure analytical and dissolution testing performance supports manufacturing