Se rendre au contenu
Aller au contenu principal

GMDP-0067

Senior Project Manager

Disponible
8
Années d'expérience
GMP - Good Manufacturing Practice
Spécialisation
Portugal
Localisation
À propos de cet expert

I am a biotech project and technical operations professional with experience supporting cell and gene therapy programmes across CMC, GMP manufacturing, technology transfer and CDMO operations. I specialise in coordinating complex cross-functional programmes from development and technology transfer through manufacturing readiness and clinical production. My experience includes CDMO and vendor management, GMP manufacturing, process optimisation, quality systems, risk management, stability programmes, technical documentation and coordination across Manufacturing, QC, QA, Regulatory and external partners. I work particularly well in environments where technical complexity, multiple stakeholders and tight manufacturing timelines need to be translated into a clear, structured and executable project plan. I support emerging biotech and life-science companies that need experienced CMC/project management expertise without the commitment of a full-time hire.

Compétences

Expert
ATMP Stability Study Design & Execution Sterile manufacturing
Avancé
Batch Release CAPA Management Biologics & biosimilars Regulatory Submissions Process validation SOP Writing & Review Deviation Management
Request this profile

Anonymised CVs are free during our launch phase. We do ask you to create a company account and confirm your email address first — that keeps our experts' profiles out of the hands of anyone just passing by.

Log in Create a company account