Sandrine Martins
Product Development Project Manager @Stromacare
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WORK HISTORY
Product Development Project Manager @Stromacare
Lyon, FR
I\'m fully involved in a monoclonal antibody development for solid cancer treatment at a preclinucal stage. Management and coordination of toxicity studies in monkeys and analytical validation of Pharamcokinetics (PK), Pharmacodynamicics (PD) and Anti-Drug Antibodies (ADA) in collaboration with CRO. Compliance with GLP and regulatory guidelines ICH/EMA /FDA. Collaboration with toxicology and analytical method experts. I also take part/manage studies related to product development and characterization (lead screening, developability, CMC) and regulatory Scientific Advice (EMA).
EDUCATION
Université de Strasbourg
Master 2 (M2)
ABOUT SANDRINE MARTINS
Sandrine MARTINS Project leader - Senior Scientist / Biologics / Drug development / Immunotherapy / Analytics R&D, Industrialization s••••••••@live.fr With more than 10 years of project management experience, I offer my expertise and knowledge in development activities for a biotechnology, pharmaceutical or medical device industrial company. I appreciate collaborative working and will be happy to integrate a development job position in a driven human team. The “nice to have” is my efficiency to solve complex issues specifically related to biologic field. Ultimately, I ‘m used to apply regulations requirement (ICH, cGLP, cGMP,21CFR Part 820, ISO13485, MDR, USP, Ph.Eur, etc.) in my activities. Strengths: Highly creative and tenacious, I investigate deeply the entrusted topics to find appropriate solutions integrating states of arts and company targets. My pedagogic and targeted communication with the whole of stakeholders facilitate the objectives achievement. Quality driven and rigorous I am invested in continuous improvement considering the quality, regulatory and operational goals. Well organized, I can handle many projects in parallel. I am effective to manage priorities and respond to the needs. Weaknesses: Linked to my passioned side, I may forget sometimes to “click zoom out”. Understood, I work on it. If you are looking for a talkative or very expressive associate, my \"typed introverted\" personality might be a weakness.
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