Chidindu Nkwazema
Consultant - Sr. Process Engineer/Scientist
Durham,US
Summary
Experienced and self motivated Process Engineer/Scientist with over 7 years of combined experience in gene therapy drug development and in the Biopharmaceutical industry. Skilled in leading/conducting experiments, upstream process development, data entry and analysis, adherent and suspension cell culture, CQV activities, tech transfers, and project management. Extensive knowledge of FDA regulations, cGMPs, technical writing, aseptic processing, development of industry SOPs, and pharmaceutical terminology. Proven track record of successfully leading team based projects, and leveraging research, analytical and leadership skills to drive success in the life science industry.
Overview
12
12
years of professional experience
7
7
years of post-secondary education
1
1
Certification
Work History
Snr. CQV Engineer/Consultant
FUJIFILM Diosynth Biotechnologies
02.2025 - Current
- Team lead for downstream CQV team.
- Led team through successful IQ/OQ/PQ/IOQSR execution for twenty-six (26) downstream systems.
- Established strong working relationships with clients through exceptional communication skills, fostering trust and collaboration.
- Achieved successful project outcomes by maintaining accurate documentation and meeting strict deadlines.
- Support generation of all CQV Downstream Documentation – FAT wraparounds, DQ, RTM, QRA, SAT/IOC and IOQ, including Final Reports.
- Generate Downstream Bridging document, ensuring full alignment with Process Science (PS) in relation to supply of CPPs and CQAs.
- Point CQV person for Vendor review for all Downstream Vendor Packages. CQV SME for all Downstream Systems.
- Perform and lead all field walkdowns for all systems.
- Lead CQV review, aligning with Transition Group in relation to review and approval of all Turnover Packages, both Vendor and Contractor Packages within the Process Equipment Support scope.
- Liaise with CQV SWAT Team in relation to punch list closure both pre-M/C and during the CQV execution phase for all Process Equipment Support systems.
- Liaise with CQV PM and Lead Scheduler in relation to schedule creation and management for all Downstream Systems, ensuring all correct predecessors and successors are in place.
- Ensure Commissioning readiness of all Downstream Systems to support equipment Start-up and IOQ Testing.
- Lead CQV Downstream Systems with EIDA, ensure full traceability at all times for all systems.
- Liaise with CQV Document Generation Lead in relation to generation and approval of DQ/Design.
Senior Process Engineer
Advanced Medicine Partners
01.2024 - 02.2025
- Provided technical assistance during project executions and when issues arose.
- Played key role in site start-up activities.
- Conducted root cause analysis to identify, prioritize and eliminate process losses.
- Participated in project reviews to enable ongoing status tracking and reporting.
- Leveraged Saleforce for document creation. management and SOP development.
- Reviewed processes, identifying areas requiring improvement.
- Coached newly hired employees while observing progress and delegating tasks.
- Involved in manufacturing equipment procurement and IQ/OQ/PQ activities.
- Collaborated with equipment vendors to address operating issues and support rapid recovery.
- Author, review, and approve experimental and Process protocols and summary reports within Upstream and Downstream Process Development (Pre-Clinical/Clinical Drug Product)
- Author, review, and approve SOP, Specification, and Protocol drafts.
- Lead and execute small-scale and full-scale process development batch manufacturing in an AAV and LVV-based gene therapy pilot lab, with involvement in Cell Expansion, Upstream, Downstream large- and small-scale Bioreactors (suspension-based)
Senior Process Engineer
Jaguar Gene Therapy
04.2023 - 01.2024
Process Engineer
Jaguar Gene Therapy
03.2021 - 04.2023
- Identified problems and recommended new processes to improve efficiency.
- Analyze data to make scientific based recommendations and write reports based on experimental results
- Establish key tech transfer and process characterization documentation to support tech transfer of suspension process to CDMO as required.
- Developed and review documentation, including protocols, SOPs, Process Flow diagrams and specifications, to meet process requirements and regulatory standards.
- Assists in producing pre-clinical products that meets site's strategic objectives and in compliant with cGLPs.
- Support regulatory submissions for all programs as required by authoring relevant documents such as summary reports.
- Contributed and authored Job Safety Analysis documents for equipment used in manufacturing to ensure safety protocols are being followed.
- Assisted in installation and qualification of production equipment for lab start-up.
- Skilled in upstream process techniques with vast knowledge in gene therapy upstream and suspension/adherent cell culture processes.
Bioprocess Engineer
AveXis Inc
05.2019 - 03.2021
- Contribute, Review, and Author On the Job Training (OJT) documents, SOPs, Protocols, and MBRs for site start-up.
- Assists in producing clinical and commercial products on annual basis that meets the site's strategic objectives and in compliant with cGMPs.
- Contributed and authored Job Safety Analysis documents for equipment used in manufacturing to ensure safety protocols are being followed.
- Assisted in commissioning and qualification of manufacturing equipment for site start-up.
- Skilled in media and buffer preparation.
- Skilled in cell expansion techniques with vast knowledge in adherent and suspension cell culture processes.
- Executed upstream and downstream procedures, including Flocculation and clarification, depthfiltration, polish filtration, CEX chromatography, and Ultracentrifugation pivotal in the production of clinical materials.
- Skilled in use of manufacturing equipment like small and large scale bioreactors, TFF systems, Chromatography skids and Ultracentrifugation process.
- Enter and assist in analyzing data from cell expansion process runs.
- Contribute to investigations and involved in creation of corrective action plan documents.
- Responsible for maintaining quality standards to meet cGMP requirements, CFRs, and internal company policies directly related to manufacturing processes.
Undergraduate Researcher
Biomanufacturing Research Institute and
Technology Enterprise, BRITE
05.2018 - 05.2019
- Develop synthetic methodologies into the total synthesis of the natural product Ecteinascidin 743.
- Development of new synthetic methodologies which will be used to develop novel scaffolds that can serve as templates toward the synthesis of natural products or biologically active small molecules.
- Explore structure activity relationship of small molecules to identify novel compounds targeting parasitic disease such as Schistosomiasis.
Pharmacy Technician
Walgreen's Pharmacy
04.2016 - 05.2019
- Responsible for efficient resolution of customer inquiries and/or activities which may include refill dates or arrival of new prescription.
- Prepare labels and fill prescriptions for hundreds of customers daily and accordingly, Refill and address third-party issues for patients.
- Manage special orders, maintain and stock pharmacy inventory, and maintain appropriate documentation.
- Answer incoming phone calls and address questions from customers and healthcare providers.
Youth Program Education Assistant
Murdoch Developmental Center - NC DHHS
07.2014 - 05.2019
- Coordinates and manages patient care programs for younger mental health patients.
- Provides services to individuals with intellectual disabilities/developmental disabilities who display extreme behavioral challenges.
- Accompany individuals to classrooms as teacher assistants and job sites as job coaches.
- Coordinated, administered and delivered mental health support services to patients.
- Maintained strict confidentiality guidelines regarding all clients, conversations and referrals and also assist individuals to identify their need for treatment programs.
- Helped improve patient and staff interactions to minimize presence of target behaviors.
- Promoted after 3 years.
- Employee of the month of June 2015.
- First Aid and CPR certified.
Education
Master of Science - Pharmaceutical Sciences
Eshelman School of Pharmacy - UNC-CH
Chapel Hill, NC 08.2019 - 05.2022
B.Sc - Pharmaceutical Sciences
North Carolina Central University
Durham, NC 08.2017 - 05.2019
Associate of Science - Pre-Pharmacy
Durham Technical Community College
Durham, NC 08.2013 - 05.2016
Skills
Tech Transfer
DeltaV
Critical thinking
Leadership
Design of Experiments
JMP
AMBR systems
CQV Activities
IQ/OQ/PQ
Problem-solving
Teamwork
Flexible & Adaptable
Analytical skills
Project Management
Data Analysis
Process flow analysis
Documents and reports
Site Start-up
QMS/QDS Systems
SOP
Certification
Kneat, TrackWise, ComplianceWire, SharePoint, LIMs, Veeva QualityDocs Systems, EIDA
Affiliations
- Member, International Society for Pharmaceutical Engineering (ISPE)
- Member, American Chemical Society (ACS)
Additional Information
- BRITE Scholarship (06/2018 - 05/2019)
- Pounce Award - 06/2021
Academic Projects
- Research on isolation and identification volatile components of the flowers of Artocarpus altilis (Breadfruit), (03/2018 - 05/2018) poster presentation of research work at ACS national conference on Aug 2018 and at BASF.
- Investigation into The Grignard Addition to Chiral Pyrazinium Salts. used towards the synthesis of Ecteinascidin 743. (05/2018 - 11/2018). Presentation of results and finsings to faculty members and students at BRITE NCCU 11/27/2018.
- Evaluating the impact of Automated Systems in Drug Manufacturing: The need for Human intervention and oversight. 08/2020 - 05/2022
Timeline
Snr. CQV Engineer/Consultant
FUJIFILM Diosynth Biotechnologies
02.2025 - Current
Senior Process Engineer
Advanced Medicine Partners
01.2024 - 02.2025
Senior Process Engineer
Jaguar Gene Therapy
04.2023 - 01.2024
Process Engineer
Jaguar Gene Therapy
03.2021 - 04.2023
Master of Science - Pharmaceutical Sciences
Eshelman School of Pharmacy - UNC-CH
08.2019 - 05.2022
Bioprocess Engineer
AveXis Inc
05.2019 - 03.2021
Undergraduate Researcher
Biomanufacturing Research Institute and
Technology Enterprise, BRITE
05.2018 - 05.2019
B.Sc - Pharmaceutical Sciences
North Carolina Central University
08.2017 - 05.2019
Pharmacy Technician
Walgreen's Pharmacy
04.2016 - 05.2019
Youth Program Education Assistant
Murdoch Developmental Center - NC DHHS
07.2014 - 05.2019
Associate of Science - Pre-Pharmacy
Durham Technical Community College
08.2013 - 05.2016