Chijinma Nancy Ewelike
MSAT Leader/ Advanced Therapies / Tech Transfer & Regulatory Strategy
Rosharon,TX
Summary
Strategic MSAT leader with 10+ years of experience driving technology transfers, process scale-up, and lifecycle support for cell and gene therapies. Proven record in regulatory-facing role, PPQ execution, and cross-functional leadership across CDMOs, QA/QC, and regulatory affairs. Trusted subject matter expert (SME) in viral vector and CAR-T platforms. Recognized for enabling clinical and commercial readiness through robust CMC execution and operational excellence.
Overview
10
10
years of professional experience
Work History
Manufacturing Science and Technology Scientist III
Lonza Biologics
04.2023 - Current
- Led MSAT workstreams supporting PPQ and late-stage tech transfer to cGMP manufacturing.
- Led MSAT project portfolio to support clinical and commercial readiness.
- Acted as SME during deviation investigations and regulatory inspections (0 major findings).
- Reviewed CMC content, provided critical input for BLA/MAA submissions and supported on-site audits.
- Mentored junior MSAT scientists.
- Drove technical governance and risk mitigation for high-impact CMC programs.
- Drove process troubleshooting and complex deviation investigations, providing SME input for CAPAs and change controls.
- Coordinate with cross-functional teams including Quality, Supply Chain, and Regulatory to deliver on-time project milestones.
- Simultaneously managed several complex projects, meeting all pertinent milestones.
MSAT Scientist II
Lonza Biologics
03.2022 - 04.2023
- Delivered technical support across several cell therapy platforms, resolving instrumentation-based deviations.
- Simultaneously managed several complex projects, meeting all pertinent milestones.
- Performed complex troubleshooting and assisted in leading initiatives to solve challenging scientific problems.
- Trained new employees on GMP compliance issues relevant to lab setting.
- Enhanced laboratory efficiency by streamlining experimental protocols.
Senior Operating Specialist
Lonza Biologics
11.2020 - 03.2022
- Collaborated with cross-functional teams to achieve project goals on time and within budget.
- Improved customer satisfaction rates through proactive problem-solving and efficient complaint resolution.
- Partnered with QA, MSAT, and manufacturing to deliver CAPA strategies and system upgrades.
- Championed the adoption of new software tools that streamlined workflows across multiple departments.
Manufacturing Associate
Bellicum Pharmaceuticals, Inc
12.2016 - 11.2020
- Drove upstream/downstream process execution for autologous cell therapies.
- Authored and revised GMP documentation, SOPs, and deviation reports.
- Managed team performance by training, mentoring, and motivating employees.
- Reviewed processing schedules and production orders concerning inventory requirements, staffing requirements, work procedures and duty assignments, considering budgetary limitations and time constraints.
- Trained 10+ staff in GMP manufacturing, aseptic techniques, and cell manipulation.
- Established and implemented Training Matrix SOPs, as well as structured and standardized training policies and procedures for Manufacturing Associates.
Education
Master of Science - Healthcare Administration
The University of Texas Rio Grande Valley
Edinburg, TXBachelor of Science - Biology
University of Houston
Houston, TXSkills
- Cell & Gene Therapy / CAR-T / Viral Vectors
- Tech Transfer / Process Scale-Up / PPQ Strategy / Lifecycle Support / Deviation Management
- Regulatory Compliance: BLA/MAA, FDA, EMA
- Regulatory Support: IND/CTD
- Deviation & CAPA Management / FMEA
- CDMO Oversight / Cross-functional Team Leadership
- Process Monitoring / PAT / Tech Roadmapping
Technical Skills & Platforms
- Platforms : CliniMACS Prodigy / Sepax / G-Rex / Sartorius Systems / Bioreactors / Aseptic Fill-Finish / Single-Use Systems
- Digital Systems: LIMS / MODA / MES / Process Control Systems (e.g., Statistica)
- Quality Systems: Deviation Management / Change Control / Validation Lifecycle
Timeline
Manufacturing Science and Technology Scientist III
Lonza Biologics
04.2023 - Current
MSAT Scientist II
Lonza Biologics
03.2022 - 04.2023
Senior Operating Specialist
Lonza Biologics
11.2020 - 03.2022
Manufacturing Associate
Bellicum Pharmaceuticals, Inc
12.2016 - 11.2020
Master of Science - Healthcare Administration
The University of Texas Rio Grande Valley
Bachelor of Science - Biology
University of Houston