Orgenesis Manufacturing Lead, Cell Therapy in Natick, Massachusetts
Orgenesis is a pioneering global biotech company which is unlocking the full potential of personalized therapies and closed processing systems through its Cell and Gene Therapy Biotech Platform, with the ultimate aim of providing life changing treatments at the Point of Care to large numbers of patients at low cost.
We are looking for an experienced Manufacturing Lead to support the establishment of the manufacturing facility, build the manufacturing team and manage and supervise the production activities. The ideal candidate will be a manufacturing leader with a demonstrated experience in production of cell therapy products in a cleanroom environment under cGMP.
Key Responsibilities include, but are not limited to:
Support the establishment of the cGMP cleanroom facility and supporting areas.
Hire, mentor and train a high-performing Manufacturing team.
Manage the Manufacturing department.
Support the generation of SOP’s and Batch Records, and the Tech Transfer activities of new processes to the site.
Oversee and lead the production of cell therapy products according to SOPs and Batch Records in a controlled, cGMP cleanroom environment.
Manage the production schedule and the daily tasks of the Manufacturing Operators.
Manage the Calibration, Validation and Maintenance plans.
Review of execued production batch records, and support deviations, CAPA’s, Change Controls and Investigations.
Ensure the production activities are performed in a manner consistent with the safety and quality policies and according to cGMP requirements.
Collaborate with other Managers and departments on site and with colleagues across Orgenesis’ global network.
An academic degree in a life sciences discipline with a minimum of 3 years of relevant experience.
Proven experience as a direct manager or leader in cGMP Manufacturing of cell therapy products.
Experience in aseptic processing in ISO 5 BSC and cell expansion using incubators is required. Experience in automated equipment for cell expansion and processing, cell wash and cryopreservation is preferred.
Technical writing skills of cGMP documents – for example: SOPs, Production Batch Records.
Working knowledge of cGMP regulations and FDA guidance for cell therapy manufacturing.
Self-organizer, keen attention to detail.
Positive interpersonal skills with the ability to interact with individuals from a variety of levels and functions.
Ability to quickly adapt to a rapidly changing environment and demands.
Responsive, can-do attitude.
*Orgenesis does not anticipate providing sponsorship for employment visa status (e.g., H-1B, OPT) for this employment position
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