Associate Director Downstream Manufacturing Operations, Gene Therapy

Passage Bio in Philadelphia, PA

  • Industry: Executive Management - Administrative/Operational Support
  • Type: Full Time
  • Compensation: $82,066.67 - 158,170.00 / Year*
position filled

Passage Bio is seeking a motivated and experienced Associate Director Downstream Manufacturing Operations, Gene Therapy to provide technical and operational leadership and expertise in manufacturing operations of Gene Therapy products.


Responsibilities:

  • Ensure the GMP manufacture and supply of high-quality gene therapy products to support early and late stage clinical product development.
  • Actively manage, oversee and guide Contract Manufacturing Organizations (CMOs) activities related to downstream operations
  • Act as the primary contact with the CMO to ensure effective collaborations with relevant internal departments (downstream Process Development, Analytical Development, QA, QC, Regulatory Affairs, Clinical Operations, and Project & Program Management), and the corresponding downstream departments within the CMO.
  • Responsible for the day-today communications with the CMO on downstream process issues and plans.
  • Collaborate closely with internal and external CMC functions & Process Development to ensure efficient technical transfer of manufacturing processes to CMOs.
  • Oversee activities such as viral testing
  • Ensure CMO network supplies high quality gene therapy products for clinical trials by providing oversight through batch record review, deviation assessment, batch disposition and supply chain oversight.
  • Act as a Person-In-Plant (PiP) during critical manufacturing operations
  • Actively guide CMO s daily operations for manufacturing operations.
  • Partner with the CMOs to ensure manpower and resources are adequate to complete operations
  • Lead and Coordinate with CMO review and approval of MBRs, Executed Batch Records and Testing Data
  • Assist in manufacturing investigation activities, CAPAs, Change Control activities at the CMO
  • Assist with the day to day and short term planning activities at the CMO
  • Oversee CMO supply chain including critical raw materials including DNA plasmids, mammalian-based production cell lines, and cell banks.
  • Partner with Quality functions (Quality Assurance/Quality Control, Qualified Persons, and CMO Quality organizations) to ensure timely and appropriate batch disposition.
  • Communicate routine production manufacturing status to company stakeholders.


Requirements:

  • BS/MS in a scientific field of study with 8+ years of relevant experience working in Manufacturing/Contract Manufacturing in the Biopharmaceutical/ biotech industry
  • Background in Chemical Engineering, Chemistry, Life Sciences is preferred.
  • Biologics experience required with AAV Gene Therapy products is preferred
  • Technical and regulatory understanding of GMP biologics manufacturing and supply chain, as well as applicable international regulations and standards in all phases of product development and commercialization
  • Strong collaboration and communication, and organizational skills required
  • Experience working with and managing third party contractors and vendors
  • Proven ability to work independently, leadership aptitude and good people skills with the desire and ability to work in a fast-paced, start-up environment
  • Excellent written and verbal communication skills
  • Knowledge of FDA, EMA, GMP, GCP and ICH regulatory requirements
  • Experience with practical aspects of GMPs in a clean room


Associated topics: bioengineering, bioinformatic, biophysics, bioprocess, biosynthetic, enzyme, genetic, msat, neuroscience, nutrition

* Estimated salary


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