Manufacturing Support Services Specialist

Position Summary

We are seeking an innovative and highly motivated Manufacturing Support Services Specialist to join our Operations team. This position will contribute to the manufacture of our advanced cell therapy manufacturing platform. The primary focus will be to support manufacturing operations and day-to-day warehouse operations. This is a hands-on position that will train in the Manufacturing and Warehouse Team.

Responsibilities

• Perform routine procedures following written instructions (SOPs, batch records, solution documents, protocols, etc.)
• Execute basic manufacturing processes in a GMP environment, e.g., buffer or media preparation, usage of controlled rate freezers, and LN2 tanks
• Support sample management and transport using LIMS
• Support Warehouse team with receiving of inbound consumables, labeling, and put-away using SAP and label printers
• Operate a forklift to accomplish warehouse duties
• Supports the maintenance and supply of warehouse storage
• Perform routine clean room and laboratory activities, including ordering of consumables and PPE items, cleaning, restocking, and equipment qualification/maintenance
• Operate in a controlled GMP environment and perform gowning as per procedure
• Initiate and support the closure of Deviation Reports and CAPAs
• Train and mentor new manufacturing support services associates on procedures, aseptic techniques, equipment, and troubleshooting skills
• Work with Quality Control, Facilities, Materials Management, Quality Assurance, and Validation to complete assignments
• Other duties as assigned

Requirements

• Bachelor’s Degree or a diploma in a scientific or related field is preferred
• 1-2 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
• Comply with the safety policies of the company and site
• Able to lift 30 pounds
• Adherence to cGMPs is required at all times during the manufacturing of Cell Therapy products
• SAP and LIMS experience is preferred
• 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

Pay

$28 - $38 an hour

Benefits

This is Cellares. Cellares is the first Integrated Development and Manufacturing Organization (IDMO) and takes an Industry 4.0 approach to mass manufacturing the living drugs of the 21st century. The company is both developing and operating integrated technologies for cell therapy manufacturing to accelerate access to life-saving cell therapies. The company’s Cell Shuttle integrates all the technologies required for the entire manufacturing process in a flexible and high-throughput platform that delivers true walk-away, end-to-end automation. Cell Shuttles will be deployed in Cellares’ Smart Factories around the world to meet total patient demand for cell therapies at global scale. Partnering with Cellares enables academics, biotechs, and pharma companies to accelerate drug development and scale out manufacturing, lower process failure rates, lower manufacturing costs, and meet global patient demand. The company is headquartered in South San Francisco, California with its commercial-scale IDMO Smart Factory in Bridgewater, New Jersey. The company is backed by world-class investors and has raised over $355 million in financing. Leveling will be based on overall experience, education, and demonstration of knowledge throughout the interview process. We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses and identifying potential inconsistencies or verification signals in application materials based on available information. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.