Manufacturing Technician I/II/III (Contract) Indianapolis, INThe 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.
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
- 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 equipmentAssist 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 equipmentAssist 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 SOPsPerform 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 ExperienceEDUCATION / CERTIFICATIONS / LICENSES - Essential/Desired
- Associate or BS degree in Biology, Biochemistry, Molecular Biology, or similar field - Strongly DesiredON-THE-JOB EXPERIENCE1-4 years of relevant cleanroom GMP industry experience in R&D, product development, or operations - Essential
- Upstream Cell culture experience with mammalian or insect cell culture in adherent or suspension platforms. Experience with bioreactor inoculation and harvest - Desired
- Experience with downstream purification techniques including Affinity Chromatography, Anion Exchange Chromatography, Ultracentrifugation, Nanofiltration, Tangential Flow Filtration, Sterile Filtration, and Fill/Finish. - Desired
- Aseptic operations in a Class 7 (Grade C) or higher cleanroom setting - DesiredSKILLS / ABILITIESExcellent 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
- Physical Demands
- While performing the duties of this job, the employee is required to meet the following physical demands:
- Work Environment
- 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
- MovementFrequently 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
- LiftingFrequently lift and/or move up to 25 pounds
- Occasionally lift and/or move up to 50 pounds
- VisionFrequently 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
- Committed to Science We are committed to scientific excellence, staying current with industry developments, making data-driven decisions, and pursuing innovation to advance healthcare.
- Urgency in Action for the Patients We operate with urgency and a commitment to delivering timely treatments to patients by accelerating our partners' programs.
- Resilience & Grit in Operations We are committed to overcoming challenges, learning from failures, and persistently striving for success.
- Execute with Excellence & Integrity We are dedicated to delivering quality results and upholding ethical principals.
- Solutions 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
- Paid sick time10 observed holidays + 2 floating holiday + 1 volunteer day 401(k) plan with company match up to 6% of salary
- Share Appreciation RightsChoice of several healthcare plansFSA and HSA programs
- Dental & vision care
- Employer-paid basic term life/personal accident insurance
- Voluntary disability, universal life/personal accident insurance
- Accidental Death & Dismemberment (AD&D) 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. Genezen has operates two locations: one in Fishers, Indiana and the second in Lexington, Massachusetts.
