Position Summary
Day Shift: 6 AM - 6 PM
Night Shift: 6 PM- 6 AM
We are seeking an innovative and highly motivated Manufacturing Support Services Specialist to join our Operations team who will contribute to the 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 warehouse operations. This is a hands-on position that will train in the Manufacturing and Warehouse Team.
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.
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
- Complete required training and ensure compliance with established internal and external control procedures
- Responsible for revising and originating production records and standard operating procedures
- 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
- Review in-process and completed documents for accuracy and to make sure batch records are turned in to area management within the specified days of completion
- Provide user feedback to engineering and process teams, support with requirements gathering and review
- 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.
- Must comply with the safety policies of the company and site
- Ability 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
What We Do
Cellares is revolutionizing cell therapy manufacturing. We are developing a one-of-a-kind solution, The Cell Shuttle, to overcome the challenges associated with manufacturing so these life-saving therapies are affordable and widely available to patients who can benefit. The clinical impact of cell therapy in treating cancer has been proven, but this therapeutic approach has several limitations, especially in manufacturing, leaving extremely sick patients waiting for treatment and desperate for hope. Since cell therapy is currently produced for a single patient at a time, it is expensive to manufacture, requiring significant time and resources, and is difficult to scale. Preclinical and clinical scientists, as well as commercial cell therapy manufacturers also lack the options to fully automate their manufacturing process quickly, safely, cost-effectively and at the scale they need. The Cell Shuttle is an automated and closed end-to-end manufacturing solution that is flexible and scalable, enabling customers to run exact processes specified for their cell therapy. Compared with the current manual manufacturing processes for cell therapy, the Cell Shuttle’s next-generation automated manufacturing solution has 10 times the scalability (meaning 10 times more patient doses can be produced simultaneously), enables a three-fold reduction in process failure rates and will reduce the per-patient manufacturing cost by up to 70 percent for most processes.
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