Cell Therapy Manufacturing Specialist
1 week ago
We are seeking a highly skilled and motivated Cell Therapy Manufacturing Specialist to join our team at Cellares. As a key member of our Process Sciences team, you will contribute significantly to the development and manufacture of our advanced cell therapy manufacturing platform.
Key Responsibilities- Perform routine procedures following written instructions (SOPs, batch records, solution documents, protocols, etc.)
- Execute manufacturing processes in both an R&D and GMP environments, following protocols and/or standard operating procedures (SOPs)
- Provide user feedback to engineering and process teams, support with requirements gathering and review
- Support reagent preparation, leukopak processing, and sample testing in an R&D and GMP environment
- Contribute to analysis and presentation of technical results at departmental meetings
- Perform routine clean room and laboratory activities including ordering, cleaning, restocking, and equipment qualification/maintenance
- Operate in a controlled GMP environment and perform gowning as per procedure
- Complete required training and ensure compliance with established internal and external control procedures
- Assist in the execution of process, equipment and cleaning validation
- Responsible for revising and originating production records, standard operating procedures, protocols and reports
- Initiate and support the closure of Deviation Reports and CAPAs
- Train and mentor new manufacturing associates on procedures, aseptic techniques, equipment and trouble-shooting skills
- Review in-process and completed documents for accuracy and to make sure batch records are turned in to area management within specified days of completion
- Work with Quality Control, Facilities, Materials Management, Quality Assurance and Validation to complete assignments
- Other duties as assigned
- Bachelor's Degree or diploma in a scientific or related field is required
- 1+ years of experience within the biotech/biopharma industry in cGMP Operations, preferably within cell and gene therapy
- Must know and follow job safety procedures, attend required health and safety training, proactively promote safety at work, and promptly report actual and potential accidents and injuries
- Must comply with the safety policies of the company and site
- Adherence to cGMPs is required at all times during the manufacturing of Cell Therapy products
- Proficiency in Drug Product-related process equipment
- Must have experience following protocols, SOPs, and/or GMP documentation
- Excellent verbal, written, presentation, and interpersonal skills
- Strong analytical and problem-solving skills
- Self-motivated and passionate about advancing the field of cell therapy
- Self-awareness, integrity, authenticity, and a growth mindset
- Desire to be part of a rapidly evolving organization, with compelling technology, and take products and processes to the next level
Cellares offers a competitive total compensation package, including a base salary, highly subsidized Medical, Dental, and Vision Plans, 401(k) Matching, Free EV Charging, and Onsite lunches. All displayed pay ranges are approximate, negotiable, and location dependent.
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