Job Overview:        

 

Passage Bio is seeking a motivated and experienced Director, Planning & CMC Project Management Gene Therapy to support the tactical and operational aspects of novel Gene Therapy at all stages of pre-clinical and clinical development.

 

Responsibilities:

 

·       Responsible for all activities related to managing and planning the overall supply chain, inventories, clinical supplies of Gene Therapy clinical candidates for domestic and international distribution from Bulk Drug Product to Patient delivery from plasmids to delivery to the patient.

·       Responsible of the overall supply chain planning of critical materials, plasmid production, drug substance and drug product supply based on the evolving clinical needs and coordinate the overall portfolio supply relative to the clinical demand.

·       Develop and lead the Clinical Supply Planning function and the associated processes and procedures.

·       Provide technical, project management support to the internal development, CMC, clinical and project management operations group

·       Plan and coordinate the external CRO/CMO activities and coordinate release and product supply and expiry.

·       Responsible for projections and forecasting of drug substance, drug product and finished product inventories and supplies.

·       Plan and coordinate necessary CMC projects, studies and activities leading to manufacturing and quality operations

·       Coordinate with internal functions such as Quality Assurance, Clinical Operations, Regulatory Affairs, Project Management and CMC & Technical Operations functions.

 

Requirements:

 

·       Demonstrated experience with clinical supply management planning, labeling, packaging, and distribution.

·       Proven track record of supply chain planning, materials/inventory management, and business process facilitation

·       Experience in clinical and/or commercial supply chain management of gene therapy products is preferred. 

·       In-depth knowledge of FDA, EMA, GMP, GCP and ICH regulatory requirements

·       Excellent written and oral communication skills

·       Ability to operate in a fast-paced, multi-disciplinary environment

·       BS/MS or PhD in a scientific field of study with 10+ years of relevant experience working in the Biopharmaceutical industry.

·       Background in Chemical Engineering, Chemistry, Life Sciences is preferred.

 

Passage Bio is an Equal Opportunity Employer - Minorities/Women/Protected Veterans/Disabled

 

 

 

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