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



Requirements

·        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


Apply for this position