Manufacturing Support Services Specialist

BridgewaterFull Timemid

OtherManufacturing

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Quick Summary

Technical Tools

OtherManufacturing

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.

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

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