Project Leader CMC

A leading Israeli biotech company recruite Project Leader CMC

Duties

· 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



Requirements

· 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. jobs@d-hr.co.il

משרות נוספות בחברה זו:

https://www.d-hr.co.il/jobs/molecular-biology-scientist

https://www.d-hr.co.il/jobs/director-qa-qc

https://www.d-hr.co.il/jobs/project-manager-for-clinical-stage-project