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

• Bachelors Degree with experience in a laboratory or biomanufacturing environment, OR
• Masters degree in a life sciences or bioengineering field

Mandatory Experience

• Prior experience in GMP cell manufacturing environment within the biotech/pharmaceutical industry, including the operation of bioreactors in the production of iPSC (pluripotent stem cell) or ES (embryonic stem cell) derived therapies in a cGMP environment 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

• 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 in Watertown, MA or other Boston metropolitan site (to be determined)

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