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Cell Therapy Specialist
2 months ago
BlueSphere Bio is a pioneering immunotherapy company dedicated to developing innovative T-cell therapies for the treatment of various cancers. Our proprietary platform technologies have enabled the creation of novel TCR-T cell therapy pipelines and cancer vaccines, addressing unmet medical needs in both blood and solid tumors.
The Product Development organization at BlueSphere Bio aims to accelerate the translation of research discoveries into new cancer therapeutic medicines through collaboration with CMC, clinical, and business development functions.
Responsibilities- Perform cell processing activities, media formulation, product sampling, and other manufacturing needs as necessary, commensurate with the employee's level of training and experience.
- Work primarily in Grade B and Grade C aseptic manufacturing environments, with occasional support of process development runs in the Manufacturing Science and Technology Laboratory.
- Perform cell manufacturing-related activities while wearing clean room attire in an aseptic cGMP manner.
- Develop and maintain expertise in unit operations.
- Document production operations in corresponding batch records and log books per established procedures, ensuring accuracy and timely completion.
- Identify and communicate real-time manufacturing issues (deviations and atypical results) to Manufacturing Management and the Quality team promptly.
- Input and upload manufacturing data in real-time to an existing database.
- Collaborate with the Quality team to author out-of-specification (OOS) reports, deviation investigations, and corrective and preventative actions.
- Author or edit SOPs, batch records, training records, logbooks, validation plans, and technical reports as assigned.
- Handle human blood and human blood-based product intermediates; assist with warehouse management, critical reagents, and material inventory reports.
- Review batch records and logbooks, and resolve comments.
- Participate in project teams (continuous improvement initiatives).
- Train new or junior employees on equipment and unit operations.
- Bachelor's degree in 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.
- Ability to stand for multiple hours and lift 20 pounds.
- Excellent verbal and written communication skills are required.
- Computer literacy is required, including Microsoft Outlook, Word, Excel, and PowerPoint.
- 1+ years' experience working within cGMP regulated environment, including Good Documentation Practices (GDP).
- 1+ years' experience with Mammalian Cell Culture.