Project Leader CMC Position
About The Position
BiomX is a leading Israeli biotech company developing novel therapeutics based on the human microbiome.
· Identification of potential CMOs and CROs for various CMC activities and QC activities; negotiation of contract and timelines; close follow up and overview of ongoing activities.
· Definition of work plan with CMO, review of results and documentation.
· Assist Head of units in project managing of all CMC operations
· Responsible for ensuring standard of manufacture suitable for clinical trials
· Identification and management of consultants for development and production
· Support preparation of CMC section for regulatory submissions
· PhD/M.Sc degree in Life Sciences, Biotechnology engineering or equivalent with a minimum of 3 years of relevant industry experience
· Proven working experience in project management
· Advanced knowledge and experience in managing CMOs to ensure optimal project progress
· Familiarization with regulatory requirements for different aspects of drug manufacturing, release criteria and stability requirements in line with ICH and FDA guidelines
· Experience with biological drugs is an advantage
· Experience with development of early clinical stage drugs is an advantage.
· Project Management Professional (PMP) / PRINCE II certification is an advantage
· Ability to assess and prioritize multiple tasks, projects and demands
· Good communication skills, leadership and excellent interpersonal relationships
· Excellent organizational skills