Manufacturing Technician II/III

Genezen•Indianapolis, IN

13d

About The Position

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. WORKING AT GENEZEN 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. JOB SUMMARY 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.

Requirements

Associate or BS degree in Biology, Biochemistry, Molecular Biology, or similar field
1-5 years of relevant cleanroom GMP industry experience in R&D, product development, or operations
Experience with mammalian cell culture in 2D and/or 3D platforms
Excellent computer, verbal, and written communication skills
Ability to work independently with minimal supervision as well as working effectively as part of a team
Able to adapt quickly to changing ideas, responsibilities, strategies, and other processes
Willing to work in an environment where individual initiative, collaboration, and accountability are valued
Criminal background check required

Nice To Haves

Upstream Cell culture experience with mammalian or insect cell culture in adherent or suspension platforms. Experience with bioreactor inoculation and harvest
Experience with downstream purification techniques including Affinity Chromatography, Anion Exchange Chromatography, Ultracentrifugation, Nanofiltration, Tangential Flow Filtration, Sterile Filtration, and Fill/Finish

Responsibilities

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
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
Other duties as assigned