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Sr. Manager, Manufacturing Sciences & Technology

Job in Cary, Wake County, North Carolina, 27518, USA
Listing for: Asahi-Kasei
Full Time position
Listed on 2026-09-16
Job specializations:
  • Design & Architecture
    Manufacturing Engineer, Regulatory Compliance Specialist
Salary/Wage Range or Industry Benchmark: 160000 - 175000 USD Yearly USD 160000.00 175000.00 YEAR
Job Description & How to Apply Below
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  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:

The Senior Manager, Manufacturing Sciences & Technology (MS&T) serves as the MS&T Product Lead for a commercial small molecule product, leading execution of the manufacturing science strategy across a high-volume, actively evolving commercial program. The product's complicated coating and challenging dissolution profile make process robustness, in-process control, and analytical alignment central to the role. The commercial network produces over 100 batches per year at a single U.S.

-based CDMO partner, with several additional development activities, scale changes, and new manufacturing suites coming online in parallel.

This Senior Manager position is responsible for leading execution of PPQ studies for new scales, suites, and process improvements entering the network, and is responsible for the execution and ongoing performance.

The Senior Manager serves as the MS&T Subject Matter Expert (SME) for the product and owns manufacturing investigations, change controls, and continuous process verification (CPV) collection and evaluation across a high-throughput commercial program, with particular technical focus on coating uniformity, dissolution performance, and process capability at commercial scale. The role authors the technical content of regulatory submissions supporting global filings and launch expansion, including NDAs, CBE-30s, annual reports, and international market submissions, and supports production timing and capacity planning with Supply Chain and Commercial Operations to sustain an active, high-volume manufacturing calendar.

The position is based in Cary, NC, with regular on-site presence expected at the Company's U.S.

-based CDMO partner to support ongoing manufacturing and process and equipment upgrades.

The base compensation range for this role is $160-175K. 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 Product & Manufacturing Technical Leadership 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.

Serves 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.

Process Development, Validation & Lifecycle…
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