Manufacturing Technician II/III

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 Manypeople 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. ESSENTIAL JOB FUNCTIONS 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 SPECIAL JOB REQUIREMENTS Adaptability required as work schedule may change based on business needs Criminal background check required Other duties as assigned KNOWLEDGE, SKILLS AND EXPERIENCE EDUCATION / CERTIFICATIONS / LICENSES Associate or BS degree in Biology, Biochemistry, Molecular Biology, or similar field Strongly Desired ON-THE-JOB EXPERIENCE 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 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 SKILLS / ABILITIES 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 PHYSICAL DEMANDS 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 Movement 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 Lifting Frequently lift and/or move up to 25 pounds Occasionally lift and/or move up to 50 pounds Vision Frequently utilize close vision and the ability to adjust focus Communication Frequently required to communicate by talking, hearing, using telephone and e-mail GENEZEN'S CURES VALUE-BASED COMPETENCIES C ommitted to Science We are committed to scientific excellence, staying current with industry developments, making data-driven decisions, and pursuing innovation to advance healthcare. U rgency in action for the patients We operate with urgency and a commitment to delivering timely treatments to patients by accelerating our partners' programs. R esilience & Grit in operations We are committed to overcoming challenges, learning from failures, and persistently striving for success. E xecute with Excellence & Integrity We are dedicated to delivering quality results and upholding ethical principals. S olutions driven for our partners We are committed to being a proactive, collaborative, creative and open-minded partner. GENEZEN'S BENEFITS Paid vacation days, amount based on tenure 401(k) plan with company match up to 6% of salary, vested immediately Choice of several healthcare plans FSA and HSA programs Employer-paid basic term life/personal accident insurance Voluntary disability, universal life/personal accident insurance ADDITIONAL DETAILS Nothing in the job description for this role restricts management’s right to assign or reassign duties and responsibilities to this job at any time. This position requires a criminal background check. Genezen is an Equal Opportunity Employer. Genezen participates in EVerify. Genezen is interested in every qualified candidate who is eligible to work in the United States; however, we are not able to sponsor visas. Locations: Fishers, Indiana; Lexington, Massachusetts. This position requires a criminal background check and drug screening. Genezen is an Equal Opportunity Employer. Genezen is interested in every qualified candidate who is eligible to work in the United States; however, we are not able to sponsor visas.

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