Manufacturing Support Services Specialist

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