Our Core Competencies

Product Experience. Deep experience with manufacturing and testing of the following biological Drug Substance/Drug Product: vaccines, adjuvants, recombinant proteins, conjugated proteins, viral vectors, cell & seed bank systems. Good knowledge in antibodies, mRNA-based products, Cell & Gene Therapy products and medical device combination products.

Scientific Expertise: Protein Engineering, Molecular Biology, Protein Biochemistry, Cell Biology Microbiology, Immunology and Vaccine Manufacturing & Testing.

CMC Regulatory Experience spanning all product life-cycle stages: Specifically contributed to the development and worldwide licensing of several vaccines, including dossier authoring (e.g. Cervarix cervical cancer vaccine, H1N1 pandemic Flu vaccine, Shingrix zoster vaccine) as well as to the worldwide license maintenance of the entire GSK vaccines portfolio (N = 25+ products), leading to submissions of hundreds of CMC variations every year.

Worldwide Regulatory Guidance and Requirements: Deep knowledge of US and EU regulations, including European and US Pharmacopoeias associated with manufacturing and testing of biological drug substance and drug product (i.e. QC specifications and test validation, stability programs, viral clearance, process validations, seed and cell banks testing). Hands on experience of other countries such as Canada, Japan, China, Brazil, South Korea, etc.

Non-clinical Regulatory Experience : Authoring of non-clinical M4, M2.4 and M2.6 e-CTD sections of Cervarix vaccine

Management of Change Control Process and Quality Systems: release process, deviations & corrective and preventive actions, including regulatory inspections (FDA, EMA, Japan, Canada, etc.).

Change management: supported 3 major organizational changes.

Project & Team Management: Objective-driven mindset with a can do attitude. Strong sense of planning and prioritization, and the ability to work with all levels of management, influence others, solve problems and take tough decisions