CMO Support Associate - Innovative Gene Therapy Start Up
Reporting to: Manager, Cell Therapy Operations
The CMO (Contract Manufacturing Organisation) Support Associate will support technology transfer activities related to the manufacture of Orchard Therapeutics’ innovative gene-modified cell-based therapeutic products. Such activities will include becoming a subject matter expert on the manufacturing process and communicating closely with personnel at contract manufacturing organizations to track and manage activities. This role is ideal for someone looking to work in a small team, where a person’s contribution is valued. The team is going through an exciting start-up phase, where everyone is fully involved in the development of the team dynamics.
Become a subject matter expert on the full manufacturing process, including the isolation, culture, transduction, and cryopreservation of cells, as well as drug product shipping processes.
- Train manufacturing operators
- Support implementation of process changes
- Track and trend manufacturing run data
- Track manufacturing raw material inventory and order materials
- Provide person-in-plant support for manufacturing runs
- Contribute to the compilation and review of master production records, standard operating procedures, development/validation protocols, and reports
- Contribute to the review of executed batch records
- Support investigations of deviations and non-conformances
- Participate in cross-functional activities with Process Development, Process Validation, Quality Assurance, Quality Control, Analytical Operations, Clinical Development, and commercial departments to ensure the successful achievement of company timelines and milestones
- Provide data summaries for CMC / CTD documents for regulatory filings with US and EU regulatory agencies
- Other activities as may be assigned
The ideal candidate for this position must have experience in the manufacture and delivery of cell-based therapy products with significant applied experience in the biotechnology industry.
Candidate must possess:
- A BS or equivalent in bioprocessing, medical technology, chemical engineering, or biological sciences
- Minimum of 5 years of experience in the biotechnology or pharma industry with a primary focus on the development, manufacture, distribution and delivery of cell-based therapy products
- Experience with technology transfer of manufacturing processes and controls at CMOs
- Familiarity with FDA/ICH guidelines
- Outstanding organizational skills
- Excellent written and oral communication skills
- Ability to operate in a fast-paced, multi-disciplinary industrial environment
- This position requires on site person-in-plant presence at CMOs and contract vendors on a potential global basis. Therefore, ability to travel is a prerequisite.