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
• 1+ years of cell culture manufacturing required
• 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

What happens next:

Once you apply, you'll proceed to next steps if your skills and experience look like a good fit. But don't worry – even if this position doesn't work out, you're still in our network. That means our team of expert Science & Clinical recruiters will have access to your profile, making your opportunities limitless.