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*
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.
- 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.
- 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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