Cell Therapy Manufacturing Specialist

BridgewaterFull Timemid

OtherCell Therapy Manufacturing Specialist

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Quick Summary

Technical Tools

OtherCell Therapy Manufacturing Specialist

Position Summary

Night Shift: 6 PM- 6 AM

We are seeking an innovative and highly motivated Cell Therapy Manufacturing Specialist to join our Process Sciences team who will contribute significantly to the development and manufacture of our advanced cell therapy manufacturing platform. The primary focus of this position will be to support manufacturing operations, as well as day-to-day lab operations.

Candidates should enjoy working in a fast-paced, mission-driven environment, and be prepared to tackle a broad selection of challenges as the company grows.

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