Cell Manufacturing Associate I/II (iPSC)

Role Summary

Join the Cell Manufacturing team to help establish and operate iPSC-based production in a regulated environment. You will execute end-to-end cell manufacturing processes, contribute to startup activities such as drafting SOPs and supporting technology transfer, and perform experiments using established protocols.

Responsibilities

• Set up and operate cell manufacturing equipment used for cell production
• Perform cell manufacturing processes like cell culture, expansion according to established procedures
• Maintain aseptic technique and operate within a controlled, regulated manufacturing environment
• Prepare required raw materials, assemblies, solutions, tools, and samples
• Perform cleaning and sanitization of cleanroom environment and equipment
• Set up and run analytical tests and/or in-process checks to confirm compliance with quality standards
• Perform good documentation practices on batch records and logbooks
• Contribute to scaling-up, basic trouble-shooting and assisting with technical issues and problems
• Maintain and prepare production documentation (standard operating procedures)
• Maintain personal cGMP training to ensure compliance
• All other duties as required

Qualifications

• Required: Bachelor’s degree in biology, cell and molecular biology, biomedical sciences, biomedical engineering, biomanufacturing, or a related field; 0+ years of relevant experience for Associate I
• Required: Bachelor’s degree in biology, cell and molecular biology, biomedical sciences, biomedical engineering, biomanufacturing, or a related field; 2+ years of relevant experience and 1+ years of experience with aseptic technique and cell culture for Associate II
• Required: Knowledge of cGMP regulations and Good Documentation Practices (GDP)
• Required: Experience operating cell manufacturing equipment like biosafety cabinets, incubators, bioreactors, centrifuges, pipettes, etc
• Required: Ability to document work accurately in batch records and logbooks and follow standard operating procedures
• Required: Ability to work in a regulated cleanroom environment, including extended periods in full gowning
• Required: Capacity to learn new techniques quickly and contribute to process improvements
• Required: Ability to work effectively in an ambiguous and fast-changing environment typical of manufacturing startup activities, adapting to evolving processes, priorities, and requirements
• Required: Ability to work flexible hours and respond to unplanned manufacturing needs, including potential weekend or off-shift support

Skills

• Experience operating cell manufacturing equipment like biosafety cabinets, incubators, bioreactors, centrifuges, pipettes, etc
• Ability to document work accurately in batch records and logbooks and follow standard operating procedures
• Experience with aseptic technique and cell culture

Education

• Bachelor’s degree in biology, cell and molecular biology, biomedical sciences, biomedical engineering, biomanufacturing, or a related field

Additional Requirements

• Travel: This role may require up to 10% domestic and international travel