Project Leader CMC
A leading Israeli biotech company recruite Project Leader CMC
· Manage formulation development program in house and outsourced.
· Manage fill and finish program taking into consideration route of administration for final product form.
· To perform experiments supporting formulation and DP program.
· Identification of potential CMOs for DP manufacture; negotiation of contract and timelines; close follow up and overview of ongoing activities.
· Definition of work plan with CMO, review of results and documentation.
· Overview methods for product characterization, release and stability
· Responsible for ensuring standard of manufacture suitable for clinical trials
· Overview of in-house activities that support or complement CMOs
· Identification and management of consultants for development and production
· PhD/M.Sc degree in Life Sciences, Biotechnology engineering or equivalent with a minimum of 5 years of relevant industry experience
· Advanced knowledge and experience in managing CMOs to ensure optimal project progress
· Experience in Formulation development and fill and finish production
· In depth knowledge and understanding of regulatory requirements for different aspects of drug manufacturing, release criteria and stability requirements in line with ICH and FDA guidelines
· Experience with oral formulations is an advantage.
Please submit your resume in English. firstname.lastname@example.org
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