Garuda Therapeutics Watertown , MA 02472
Posted 1 week ago
In this role you will set up, maintain, and harvest a variety of cell types from bioreactor systems, while performing necessary equipment and process troubleshooting and supporting continuous improvement efforts. The Biomanufacturing Associate also has the responsibility to support the development of standard operating procedures, support the design transfer process of cell lines from research and development into production, perform in-process inspections and regular maintenance of equipment.
Role and Responsibilities
Complete daily biomanufacturing tasks, such as media preparation, cell seeding, cell harvest, and testing of cell and media products
Perform aseptic techniques in the set-up, transfer, and harvest of cells
Perform dynamic environmental monitoring in support of the cell production processes
Document manufacturing procedures and process parameters in accordance with company policies and regulatory requirements where necessary
Operate biomanufacturing equipment such as bioreactors, biological safety cabinets, cell harvesters, incubators, tube fillers, cell separation devices, centrifuges, balances, etc.
Work with supply chain team to ensure maintenance of appropriate levels of consumables and reagents
Perform necessary maintenance and cleaning of manufacturing equipment and spaces
Stock, stage, and prepare materials
Work with the manufacturing and quality teams to report process deviations and quality parameters in a timely manner
May train other and new team members on operating procedures for processes and equipment
Qualifications and Education Requirements
Mandatory Experience
Prior experience in GMP cell manufacturing environment within the biotech/pharmaceutical industry is required
Knowledge of GMP and quality management systems
Experience with aseptic cell culture technique and good laboratory practices including but not limited to maintaining data integrity, documentation, and review
Performing cell counting and some cell biology assays
Strong written and verbal communication skills
Experience that is preferred but not mandatory
Experience with the operation of bioreactors in the production of iPSC (pluripotent stem cell) or ES (embryonic stem cell) derived therapies in a cGMP environment
Prior experience manufacturing Master and working cell banks under GMP conditions
Operation of cell processing equipment (selection, washing, culture) commonly used in cell culture laboratories
Physical Demands
Must have the ability to lift up to 50 pounds
Requires physical activity such as standing for long periods of time, walking, and working with hands
Work Environment
Must be able to work in a controlled or clean room environment requiring special gowning
Must have the ability to work safely and conscientiously in a manufacturing environment
Weekends and/or holidays may be required
May require adjustment to a shift schedule as manufacturing objectives change
Work Location will be onsite in Watertown, MA or other Boston metropolitan site (to be determined)
Garuda Therapeutics