Manufacturing Cell Therapy Specialist
4 weeks ago
Adaptimmune is a fully integrated cell therapy company, designed and built from the ground up with four U.K.- and U.S.-based biotechnology hub locations. Our comprehensive capabilities and teams include preclinical research, clinical development, translational sciences, autologous and allogeneic manufacturing, and in-house commercial and corporate operations.
Our company culture is rooted in trust, inclusion, our capacity to collaborate, and our commitment to being honest and brave in our desire to successfully transform the lives of people with cancer.
This role will provide support for the manufacturing of gene modified autologous T-cell product at our manufacturing site in the Philadelphia Navy Yard. The Specialist will perform cell processing activities, media formulation, product sampling, and other manufacturing needs as necessary, commensurate with the level of training and experience of employee. Work is primarily in Grade B and Grade C aseptic manufacturing environment, but may also include support of process development runs in the Manufacturing Science and Technology laboratory.
Ability to work flexible shifts
Responsibilities
- Performs cell manufacturing related activities while wearing clean room attire in an aseptic cGMP manner. SME on unit operations. Documents production operations in corresponding batch records and log books per established procedures ensuring accuracy and timely completion. Identifies real time manufacturing issues (deviations and atypical results) and communicates them to Manufacturing Management and the Quality team in a timely manner
- Inputting and uploading of manufacturing data in real time to existing database
- Works with the Quality team to author out of specification (OOS) reports, deviation investigations and corrective and preventative actions.
- Authors or edit SOPs, batch records, training records, logbooks, validation plans and technical reports as assigned. Handles human blood and human blood based product intermediates; Helps with warehouse management, critical reagents and material inventory reports
- Review of Batch Records and logbooks / comment resolution
- Work on project teams (continuous improvement initiatives)-
- Train new or junior employees on equipment and unit operations.
Qualifications & Experience
- Bachelor degree in a cell biology, bioengineering or medical technology related field, or equivalent experience is required.
- Ability to work flexible hours with some night and weekend availability is required. This is a start-up situation so schedules and shifts will change over time.
- Ability to stand for multiple hours and lift 20 pounds.
- Experience with working in an aseptic cleanroom with full aseptic gowning is a plus.
- Excellent verbal and writing communication skills are required.
- Computer literacy is required including Microsoft Outlook, Word, Excel and Power Point.
Desirable
- 1+ years’ experience working within cGMP regulated environment including Good Documentation Practices (GDP)
- 1+ years’ experience with Mammalian Cell Culture
- Experience working in an aseptic cleanroom with a full aseptic gowning is a plus
At Adaptimmune we embrace diversity and equality of opportunity. We believe that the more inclusive we are, the better our work will be. We welcome applications to join our team from all qualified candidates, regardless of age, colour, disability, marital status, national origin, race, religion, gender, sexual orientation, gender identity, veteran status or other legally protected category. It is our intent that all qualified applicants will receive equal consideration for employment.
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