Dalia M Abdel Rehim
BCG Bio Manufacturing Project Technical Director
Summary
With over 22 years of experience in Bio Manufacturing, expertise in sterile manufacturing, upstream and downstream processes, GMP compliance, stability of Bio pharmaceutical products, technology transfer, and scientific research. Academic background focuses on Lyophilization technique cycle design and optimization. Successfully framed and conducted practical internal trainings for students and new employees in a biomanufacturing setting. Eager to leverage ambition and skills to drive realistic effectiveness in the expanding field of Biological products Industry training, mentoring and development.
Overview
23
23
years of professional experience
2
2
Languages
Work History
Project Technical Director
BCG Bio-manufacturing and development facility project
01.2022 - Current
- Work and participate in detailing project aspects starting from preliminary steps of market research, work capacity, processes models as per GMP requirements through risk assessment, design layouts, equipment URS’s
Project Coordinator
VACSERA
01.2020 - 01.2022
- Work closely with top management in Preparing/updating QMS, project status reports, and creating, maintain comprehensive project documentation, plans and reports.
Quality Project Coordinator
VACSERA
01.2019 - 01.2022
- Work closely with top management in conducting project requirements review, Coordination with the internal project team (engineering, manufacturing) for the planning and execution of the projects, participating in preparing projects audit reports and identifying non-conformances issues and work with relevant departments in mitigation.
QA Supervisor
Novo Nordisk – VACSERA
01.2016 - 01.2019
- Ensure adherence to MOH guidelines as well as legal obligations Supervise inspectors, technicians and other staff and provide guidance and feedback. Oversee all product development procedures to identify deviations from quality standards. Inspect final output and compare properties to requirements. Approve the right products or reject defectives. Keep accurate documentation and perform statistical analysis.
BCG & Tuberculin Production Manager
VACSERA
01.2010 - 01.2013
- Planning and overseeing the production activities and all its relevant processes achieving the targeted sale plan. Applying GMP requirements in production units. Participating in personnel training requirements.
R&D Unit Head
VACSERA
01.2010 - 01.2013
- Biological product improvement and development including implementing recent approaches, product shelf life improvement techniques applying system and statistical data analysis.
BCG Vaccine Project Team Member
VACSERA
01.2009 - 01.2010
- Participated in setting up the requirements for BCG vaccine manufacturing project including identifying GMP requirements, conceptual designing, lab scale production, setting equipment specification, tenders and good communication with stakeholders.
Production Specialist
VACSERA
01.2002 - 01.2009
Education
Master of Pharmaceutical Science - Industrial Pharmacy
Faculty of Pharmacy, Cairo University
Cairo 05.2001 -
New Trends in Biotechnology - undefined
Biotechnology Center, Cairo University
Methods of achieving and improving Productivity and quality -
Cairo University
01-2002
Bachelor in Pharmaceutical Science - Pharmaceutical Sciences
Faculty of Pharmacy, Cairo University
Cairo 05.2001 -
Skills
Sterile bio-manufacturing
Quality assurance
GMP
technology transfer
risk management
freeze drying
Stability studies
Scientific research
undefinedCommunications - Conferences Presentations
01/01/14, Stability Study of The Therapeutic BCG-T Using Lyophilization Technique and Different Stabilizing Agents, 5th International scientific conference of Faculty of Pharmacy, Cairo University
Outstanding Certifications
May1,2025, TOT " Training of Trainer professional program", Adult Education Center, Ain Shams University
March 28,2025, Vaccine Manufacturing Industrial Fellowship Tutor training program, Africa CDC, Cape Town.
December 6, 2022, Hands on training of WHO virtual cGMP Training Marathon for Vaccine manufacturing: Sustaining a GMP - Compliant Environment, WHO Local Production Unit
November 8,2022, WHO virtual cGMP Training Marathon for Vaccine manufacturing: Sustaining a GMP - Compliant Environment" confirmed participation, WHO Local Production Unit
May 01,2011, IVLP alumna US Department of State- 'International Visitor Leadership Program in Oncology".A program on cancer Research, Prevention and Treatment supported by The Department of States, USA.
10/15/2009, PMP " Project Management Professional " successful completion of PMP preparation course.
Personal Information
- Date of Birth: 02/26/80
- Marital Status: Married
Publications
- 01/01/15, Realtime stability and viability prediction of the anticancer BCG after lyophilization, Drug development and Industrial pharmacy
Training with Certifications
- 27/03/2025, Vaccine Manufacturing Industrial Fellowship Tutor training program, AVMI- AfricaCDC
- 10/01/2023, Strategic Planning, basic level for top management, certified by VACSERA
- 02/01/2022, Effective warehouse management, requirements planning, inventory control and stagnant handling
- 04/01/2018, Internal Audit Awareness According to ISO 9001:2015 EGY VAC Training center
- 12/01/2017, ISO 9001:2015 Awareness, EGY VAC Training center
- 03/01/2011, 120 hours hands-on training in BARDA/USU Influenza Vaccine Bio-manufacturing training
- 11/01/2010, New Trends in Biotechnology – Biotechnology Center, Cairo University certified
- 10/01/2010, TQM (Total Quality Management) – ESO Certified, The Egyptian Society for Quality
- 10/01/2009, PMP (Project Management Professional) preparation course & Microsoft Project – IBM Certified
- 06/01/2009, Pharmaceutical Products Stability - VACSERA certified
- 12/01/2004, Basics in the Safety of Laboratory Animals, VACSERA certified
- 08/01/2003, Molecular Genetics program, VACSERA certified
- 02/01/2003, Quality in Laboratory Program, VACSERA certified
Timeline
Project Technical Director
BCG Bio-manufacturing and development facility project
01.2022 - Current
Project Coordinator
VACSERA
01.2020 - 01.2022
Quality Project Coordinator
VACSERA
01.2019 - 01.2022
QA Supervisor
Novo Nordisk – VACSERA
01.2016 - 01.2019
BCG & Tuberculin Production Manager
VACSERA
01.2010 - 01.2013
R&D Unit Head
VACSERA
01.2010 - 01.2013
BCG Vaccine Project Team Member
VACSERA
01.2009 - 01.2010
Production Specialist
VACSERA
01.2002 - 01.2009
Master of Pharmaceutical Science - Industrial Pharmacy
Faculty of Pharmacy, Cairo University
05.2001 -
Bachelor in Pharmaceutical Science - Pharmaceutical Sciences
Faculty of Pharmacy, Cairo University
05.2001 -
New Trends in Biotechnology - undefined
Biotechnology Center, Cairo University
Methods of achieving and improving Productivity and quality -
Cairo University
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