Mane (Mahmoud) Lashin
Basel
Summary
Dynamic leader with extensive experience in Biotechnology, driving quality management systems and operational excellence in mRNA vaccine development. Proven track record in regulatory submission success and inspection readiness, showcasing strong decision-making and problem-solving skills. Spearheaded initiatives that enhanced compliance and efficiency, contributing to the launch of multiple groundbreaking products.
Overview
18
18
years of professional experience
Work History
Head of Product Quality Leads (Director)
Moderna
Basel
04.2023 - Current
- Lead a global team of seven Product Quality Leads (PQLs), acting as the single quality contact within CMC product teams for mRNA vaccines.
- Partner with cross-functional teams (Regulatory CMC, Technical Development, Clinical) to ensure CMC readiness for global regulatory submissions.
- Designed and implemented core roles and responsibilities for PQLs, creating clear value addition within CMC product teams.
- Developed a comprehensive quality strategy for the respiratory vaccine portfolio, aligning manufacturing, testing, and regulatory requirements.
- Contributed to the submission, approval, and launch of five mRNA vaccine products across multiple markets, with two approved to date.
- Designed and implemented a robust process for commercial specification management and shelf-life extension saving two FTE work hours.
- Represent quality in regulatory discussions, ensuring timely resolution of inquiries from authorities, including the FDA, EMA, Swissmedic, PMDA, and others.
- Drive quality readiness for product launches, ensuring global alignment of quality systems to support manufacturing, supply chain, and distribution activities.
Associate Director QA Operations
Moderna
Basel
07.2021 - 03.2023
- Led a team of five QA managers, overseeing operations at four external contract manufacturers for drug substances and drug products of mRNA vaccines.
- Built and maintained strong relationships with external CMOs, enabling effective navigation of complex challenges during the COVID-19 pandemic.
- Resolved complex deviations, out-of-specifications, and market complaints, ensuring uninterrupted supply during peak demand.
- Oversaw the onboarding and integration of new manufacturing sites into Moderna's global network, focusing on quality systems, training, and operational readiness.
- Directed and contributed to the implementation of major lifecycle management (LCM) strategies at external manufacturers.
- Led site inspection readiness efforts, ensuring compliance with global regulatory standards, and achieving successful inspection outcomes.
- Thrived in high-pressure situations, demonstrating strong decision-making, and achieving results under tight timelines.
Senior Manager QA, Cell and Gene Therapies External Manufacturing
Novartis AG
Basel
06.2018 - 06.2021
- Oversaw all quality-related activities at three external CMOs, ensuring seamless supply of viral vectors, plasmids, and critical raw materials for ATMPs through robust partnerships and effective stakeholder management.
- Designed and implemented a comprehensive QA oversight program for CMOs, optimizing resource utilization while maintaining compliance and quality standards.
- Developed and executed regulatory change control submission strategies, ensuring alignment with global regulatory requirements and achieving successful approval outcomes.
- Managed QA activities for the international market launch of Kymriah, ensuring compliance and operational readiness.
- Successfully led Swissmedic inspection readiness efforts, resulting in favorable inspection outcomes.
Process Expert MST
CSL Behring
Melbourne
10.2016 - 05.2018
- Led a team of six personnel through the successful technology transfer of sterile IV Human Albumin (AlbuRx) from Switzerland to Australia.
- Contributed as a core member of the strategic projects team for the construction and commissioning of a new manufacturing facility for IV Human Albumin.
- Designed and executed qualification activities, including Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) for critical equipment and systems.
- Developed and implemented a robust contamination control strategy for the new facility, ensuring compliance with global industry standards and regulatory requirements.
- Demonstrated strong leadership and problem-solving skills, delivering project milestones under tight timelines and regulatory scrutiny.
Senior QA Compliance
CSL Behring
Melbourne
11.2012 - 10.2016
- Served as a core member of the project team for the construction of a new manufacturing facility for Sterile IV Immunoglobulin G (Privigen), contributing to key strategic decisions and project execution.
- Ensured quality compliance through all phases of DQ, IQ, OQ, PQ, and process validation, aligning with global regulatory requirements.
- Developed and monitored key quality metrics (KPIs) throughout the project phase and during routine operations to ensure consistent performance.
- Managed complex deviations in upstream, downstream, and aseptic filling processes for sterile IV Immunoglobulin G, implementing effective solutions to maintain operational continuity.
- Chaired the global change control panel, collaborating with technology transfer stakeholders to align on regulatory compliance and project timelines.
- Played a critical role in the successful FDA pre-approval inspection of the facility by effectively presenting 35 owned deviations, achieving zero findings.
Senior Specialist Operational Planning and Exportation
Novartis AG
Cairo
06.2012 - 10.2012
- Scheduled monthly finite activities for solid dosage forms, including granulation, compression, coating, and packaging work centers, ensuring optimal workflow.
- Coordinated all exportation activities within the solid process unit, ensuring timely and compliant delivery to international markets.
- Collaborated with sales and operations teams to adjust forecasts, aligning production schedules with market demand.
- Monitored and reported daily processing and packaging line outputs, preparing weekly and monthly KPIs to drive performance improvements.
- Performed diverse SAP activities, including process management and generating analytical reports to support operational decisions.
Manufacturing Supervisor
Novartis AG
Cairo
01.2011 - 06.2012
- Supervised a team of 20 production operators, ensuring the efficient manufacturing of solid dosage forms while maintaining high compliance standards.
- Executed Six Sigma projects to enhance process performance, achieving significant cost reductions and operational improvements.
- Coordinated cleaning validation activities across solid dosage form work centers, ensuring adherence to regulatory and quality standards.
- Developed and maintained cGMP documentation, including master batch records, standard operating procedures, validation protocols, and reports.
- Established and monitored departmental metrics and KPIs, driving continuous improvement and performance optimization.
Quality Control Chemist
Novartis AG
Cairo
09.2008 - 12.2010
- Conducted chemical analysis of starting materials, including Active Pharmaceutical Ingredients (APIs), and additives.
- Performed Out-of-Specification (OOS), Out-of-Expectation (OOE), and Out-of-Trend (OOT) investigations.
- Performed analytical method validations, instrument calibrations, instrument qualifications and Supplier Qualifications.
- Improved QC efficiency KPI by at least 20% through effective raw material test planning.
Medical Representative
Bioderma
Cairo
05.2008 - 09.2008
Pharmacist in Charge
Al-Kholfa Pharmacy
Cairo
06.2007 - 09.2008
Education
Master’s Degree - International Business Administration
Ecole Supérieure Libre des Sciences Commerciales Appliquées
01.2012
Six Sigma Green Belt -
Novartis AG Training Program
01.2012
Diploma - Total Quality Management
The American University in Cairo
Cairo, Egypt01.2010
Bachelor’s Degree - Pharmaceutical Sciences
Ain Shams University
Cairo, Egypt01.2007
Skills
- Quality Management Systems
- Technology Transfer
- Health Authority Inspection Readiness
- CMC (Chemistry, Manufacturing, and Controls)
- Operational Excellence
- Decision-Making
- Problem Solving
- Digital and automation mindset
- Team Leadership
- Thrive in high pressure environment
- Project management
Languages
Native, Fluent, B1
Personal Information
- Date of Birth: 11/02/84
- Nationality: Egyptian Australian
- Residence Permit: C Permit
Languages
Arabic
First Language
English
Proficient (C2)
C2
German
Intermediate (B1)
B1
Lithuanian
Elementary (A2)
A2
Timeline
Head of Product Quality Leads (Director)
Moderna
04.2023 - Current
Associate Director QA Operations
Moderna
07.2021 - 03.2023
Senior Manager QA, Cell and Gene Therapies External Manufacturing
Novartis AG
06.2018 - 06.2021
Process Expert MST
CSL Behring
10.2016 - 05.2018
Senior QA Compliance
CSL Behring
11.2012 - 10.2016
Senior Specialist Operational Planning and Exportation
Novartis AG
06.2012 - 10.2012
Manufacturing Supervisor
Novartis AG
01.2011 - 06.2012
Quality Control Chemist
Novartis AG
09.2008 - 12.2010
Medical Representative
Bioderma
05.2008 - 09.2008
Pharmacist in Charge
Al-Kholfa Pharmacy
06.2007 - 09.2008
Master’s Degree - International Business Administration
Ecole Supérieure Libre des Sciences Commerciales Appliquées
Six Sigma Green Belt -
Novartis AG Training Program
Diploma - Total Quality Management
The American University in Cairo
Bachelor’s Degree - Pharmaceutical Sciences
Ain Shams University
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