Cell Therapy Manufacturing Specialist

Cell Therapy Manufacturing Specialist

Kelly Science & Clinical is seeking a Cell Therapy Manufacturing Specialist for a full-time, 6 month contract position at a cutting-edge client in South San Francisco, CA. If you're passionate about bringing the latest scientific discoveries to life and are ready to take the next step in your career, trust The Experts at Hiring Experts.

Pay: $35-38.5/hr AM shifts. $38.5-40/hr for PM shifts

Schedule: 7:00am 7:30pm Sunday Tuesday; Alternating Wednesday 7:00am 7:30pm Thursday Saturday; Alternating Wednesday 7:00pm-7:30am Sunday Tuesday; Alternating Wednesday 7:00pm-7:30am Thursday Saturday; Alternating Wednesday

Overview Our client is an industry-leading company that's leading the way in advanced cell therapy manufacturing platforms and process sciences. This innovative organization is at the forefront of developing next-generation cell therapy solutions and is growing rapidly within the biotech/biopharma space. In this role, you will support manufacturing operations and day-to-day lab operations, with hands-on training across Process Development, Analytical Development, and/or MSAT prior to joining the Manufacturing Group. You will execute manufacturing processes in both R&D and GMP environments, contribute to technical presentations, and play a key role in ensuring compliance with established procedures and quality standards.

Responsibilities:

• Perform routine procedures following written instructions, including SOPs, batch records, solution documents, and protocols
• Execute manufacturing processes in both R&D and GMP environments, following protocols and standard operating procedures (SOPs)
• Provide user feedback to engineering and process teams; support requirements gathering and review
• Support reagent preparation, leukopak processing, and sample testing in R&D and GMP environments
• Contribute to the 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 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
• Revise and originate 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 troubleshooting skills
• Review in-process and completed documents for accuracy and ensure batch records are submitted to area management within specified timeframes
• Collaborate with Quality Control, Facilities, Materials Management, Quality Assurance, and Validation teams to complete assignments
• Perform other duties as assigned

Qualifications:

• 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 client 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
• Demonstrates 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