Sr. Manager, Manufacturing Sciences & Technology

Veloxis Pharmaceuticals, Inc.; Cary (NC); Hybrid; USD 160,000 - 175,000; Full time

Job summary

Veloxis Pharmaceuticals, Inc. in Cary, NC is seeking a Senior Manager for Manufacturing Sciences & Technology (MS&T) to lead the science strategy for a high-volume commercial program.

The role emphasizes coating robustness, dissolution performance, and CPV across the network and requires regular on-site collaboration with a CDMO partner. The position oversees process development, PPQ validation, lifecycle management, and cross-functional leadership across QA, QC, regulatory, and supply, while

Qualifications

• 10+ years of pharmaceutical or biotech manufacturing experience.
• Experience with technology transfer, process validation, CPV, and change controls.
• Experience with film-coated, modified-release dosage forms and dissolution testing.
• Experience supporting a high-volume commercial program and parallel scale-up.
• Experience supporting regulatory inspections and global submissions.
• Ability to mentor junior staff in a global organization.

Responsibilities

• Lead MS&T product strategy for a high-volume commercial program (100+ batches/year).
• Act as MTO lead for inspection readiness and activities.
• Develop and execute manufacturing science strategies ensuring regulatory compliance and operational excellence.
• Provide technical leadership for campaigns and scale-ups at the CDMO.
• Ensure robust, compliant, validated processes with strong dissolution performance.
• Drive continuous improvement across the program.

Skills

Fluent English

Technical leadership

Coaching

Cross-functional

Problem solving

Education

Bachelor's degree in Engineering or related

MS/PhD/MBA preferred

Job description

Company

Veloxis Pharmaceuticals, Inc. is an Asahi‑Kasei Group Company based in Cary, NC. Our purpose is to transform transplant medicine by partnering with the transplant healthcare community and developing new therapies and programs to help clinicians and patients.

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.

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.

Job Title

Senior Manager, Manufacturing Sciences & Technology (MS&T)

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.

The Senior Manager is responsible for leading execution of PPQ studies for new scales, suites, and process improvements entering the network, and for the ongoing performance and continuous process verification (CPV) collection and evaluation across a high‑throughput program.

The position is based in Cary, NC, with regular on‑site presence expected at the Company’s U.S.‑based CDMO partner to support manufacturing and process and equipment upgrades.

Base compensation range: $160–175 k. Base compensation is influenced by many factors including time in the role, previous experience, skills, knowledge, performance, work requirements, internal equity, and business/economic conditions.

Key Responsibilities

Product & Manufacturing Technical Leadership

• Serve as the MS&T Product Lead for the commercial small molecule product throughout its lifecycle, including expanding scales, suites, and line extensions.
• Act 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 Management

• Lead process development activities 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, emphasizing coating, dissolution‑related process parameters and inspection performance.
• Lead manufacturing investigations, deviations, CAPAs, and change controls, and troubleshoot 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.

Cross‑Functional Technical Leadership

• Partner closely with Process Development to transfer process knowledge and scientific understanding into manufacturing for new scales and suites; ensure all process history is properly documented.
• Collaborate with Quality Assurance to maintain manufacturing compliance, manage deviations, investigations, CAPAs, and inspection readiness.
• Work closely with Quality Control to ensure analytical and dissolution testing performance supports manufacturing and lifecycle management.
• Partner with Supply Chain to support production timing, capacity planning, and supply continuity for a high‑volume, multi‑suite manufacturing calendar.
• Build strong collaborative relationships across Manufacturing, Regulatory Affairs, Analytical Development, and Commercial Operations to support global launch expansion.

External Manufacturing Leadership

• Serve as primary technical representative to the Company’s U.S.‑based CDMO partner, with regular on‑site presence to support commercial production and parallel start‑up activities.
• Drive supplier technical performance through governance meetings, business reviews, performance metrics, and continuous improvement initiatives.
• Support technical readiness for new manufacturing suites and scale changes coming online at the CDMO.
• Resolve complex manufacturing issues through collaboration with internal and CDMO technical teams.

Regulatory & Quality Support

• Author the technical content of regulatory submissions supporting global filings and launch expansion, including NDAs, regulatory updates, annual reports, and international market submissions.
• Serve as technical representative during regulatory inspections and CDMO audits.
• Ensure manufacturing processes remain compliant with global cGMP requirements across all commercial markets.
• Support inspection readiness across internal functions and the CDMO partner.

Technical Leadership & Organizational Development

• Serve as the MS&T subject‑matter expert, providing day‑to‑day technical guidance and sound scientific judgment on coating, dissolution, and process performance matters.
• Coach and mentor scientists, engineers, and junior team members, building technical capability and an inclusive, learning‑oriented culture.
• Promote technical excellence through hands‑on problem solving, knowledge sharing, and continuous learning.
• Drive implementation of best practices and process improvements within MS&T.
• Build alignment among internal stakeholders to ensure consistent execution of technical strategy across parallel initiatives.

Required Qualifications and Skills

Education

• Bachelor’s degree in Engineering, Pharmaceutical Sciences, Chemistry, Chemical Engineering, Biology, or a related scientific discipline.
• Advanced degree (MS, PhD, or MBA) strongly preferred.

Experience

• 10+ years of progressively responsible pharmaceutical or biotechnology manufacturing experience.
• Demonstrated experience in technology transfer, process validation, CPV, lifecycle management, manufacturing investigations, and change controls.
• Experience with film‑coated, modified‑release solid oral dosage forms and associated dissolution testing strongly preferred.
• Experience supporting a high‑volume commercial manufacturing program, including parallel scale‑up or new suite qualification activities.
• Experience supporting regulatory inspections and global regulatory submissions.
• Demonstrated ability to mentor and develop junior technical staff within a global manufacturing organization and contract manufacturing network.

Core Competencies

• Strong technical understanding of pharmaceutical manufacturing processes.
• Working knowledge of film coating and dissolution science for modified‑release solid oral dosage forms.
• Effective communication and coordination skills.
• Strong coaching and mentoring skills with a focus on developing technical talent.
• Ability to apply sound scientific and technical judgment to day‑to‑day execution decisions.
• Ability to manage multiple parallel technical initiatives in a fast‑paced commercial environment.
• Fluent in English.

Travel Requirements

30–40%, domestic and international.

Hybrid

Hybrid work environment.