Manufacturing Technician I​/II​/III

Indianapolis, IN

The field of gene therapy is growing rapidly and Genezen is here to meet the exacting needs of our clients. We provide process development, produce GMP viral vectors, and provide cell transduction for gene and cell therapy clinical trials and are proud to be a part of the process that leads to new cures.

Many people have worked in environments where you feel like just another nameless part of an enormous machine. Genezen is different. We want our employees to be innovative, collaborative problem solvers who are dedicated to meeting the challenges of working at a fast-growing company. We are dedicated to empowering our employees to be their best and making Genezen a rewarding place to work.

Every employee contributes to the success of the company and you can be part of that team.

Responsible for supporting projects from advanced laboratory techniques related to viral vector production and analytics to routine performance of upstream and downstream manufacturing operations including aseptic cell culture technique, preparing solutions and media, molecular biology techniques, chromatography, TFF and general cleanroom sanitization/area maintenance. The position requires working independently, but also under the supervision of experienced personnel.

• Execute hands on project work from process development through manufacturing related to viral vector production including upstream and downstream GMP manufacturing tasks under the guidelines of established procedures and batch records
• Perform hands on laboratory procedures related to viral vector production and characterization
• Perform daily operations in the scale-up, production, harvest, clarification, purification, and fill/finish of retro, lenti, and AAV viral vectors.
• Execute production activities including cell thawing, cell passaging, bioreactor inoculation, clarification filtration, chromatography, tangential flow filtration, sterile filtration and filling of viral products following GMP guidance and according to applicable batch records.
• Maintain appropriate GDP documentation of processing activities
• Perform routine lab maintenance and maintenance of laboratory equipment
• Assist in the development of general and technical SOPs and with the creation of client specific procedures and batch records
• Maintain manufacturing material supply, primarily ensuring manufacturing spaces are adequately stocked and prepared
• Assist in the maintenance of laboratory equipment and laboratory support operations
• Follow detailed instructions with a high level of focus and attention to detail
• Complete documentation accurately and in a timely fashion
• Maintain up to date training status
• Use, clean, and maintain lab and manufacturing equipment
• Assist in troubleshooting of upstream and downstream manufacturing issues
• Cross train new staff members and fellow employees in designated processes
• Comply with all established policies and SOPs
• Perform safety inspections and maintain a safe working environment
• Participate actively in continuous improvement activities and SOP revisions in coordination with management and Quality Assurance
• Perform area sanitization and collect/dispose of waste per established procedures
• Help collect process data for metrics/trending
• Use and maintenance of cGMP equipment

• Adaptability required as work schedule may change based on business needs
• Criminal background check required
• Other duties as assigned

Associate or BS degree in Biology, Biochemistry, Molecular Biology, or similar field

Strongly Desired

1-4 years of relevant cleanroom GMP industry experience in R&D, product development,…