Manufacturing Technician I/II/III (Contract)

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.

• •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

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

Experience with downstream purification techniques including Affinity Chromatography, Anion Exchange Chromatography, Ultracentrifugation, Nanofiltration, Tangential Flow Filtration, Sterile Filtration, and Fill/Finish.

Aseptic operations in a Class 7 (Grade C) or higher cleanroom setting

Excellent computer, verbal, and written communication skills

Essential

Ability to work independently with minimal supervision as well as working effectively as part of a team

Essential

Able to adapt quickly to changing ideas, responsibilities, strategies, and other processes

Essential

Willing to work in an environment where individual initiative, collaboration, and accountability are valued

Essential

While performing the duties of this job, the employee is required to meet the following physical demands:

• •Frequently required to work in a BSL 2 environment with personal protective equipment/aseptic gowning
• •Regularly required to work around large machinery and typical utilities seen in pharmaceutical facilities
• •Occasionally exposed to moving mechanical parts; high, precarious places; toxic or caustic chemicals; hazardous waste; and risk of electrical shock
• •Occasionally exposed to extremely loud noise levels

• •Frequently required to stand; sit; walk; balance; stoop; kneel; crouch; use hands to finger, handle, or feel; reach with hands and arms
• •Occasionally required to walk; climb or balance; and stoop, kneel, crouch, or crawl

• •Frequently lift and/or move up to 25 pounds
• •Occasionally lift and/or move up to 50 pounds

• •Frequently utilize close vision and the ability to adjust focus

• •Frequently required to communicate by talking, hearing, using telephone and e-mail

C ommitted to Science

We are committed to scientific excellence, staying