Manufacturing Technician II Job at Genezen in Lexington

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 GENEZENMany 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 SUMMARYWith general supervision the individual will perform routine and non-routine manufacturing operations, including but not limited to work functions in Cell Culture, Purification, Solution & Equipment Prep areas. Operates production equipment according to SOPs to produce clinical and/or commercial products. Independently perform manufacturing of Genezen's therapeutic products and ensure this is realized and documented according to the highest industrial and GMP quality requirements This individual will carry out cGMP manufacturing operations utilizing Standard Operating Procedures (SOP), Batch Production Records and Solution prep records.ESSENTIAL JOB FUNCTIONS Independently perform manufacturing of Genezen's therapeutic products and ensure this is realized and documented according to the highest industrial and GMP quality requirements.This individual will carry out cGMP manufacturing operations utilizing Standard Operating Procedures (SOP), Batch Records and Form Preps. Primary responsibilities include the following:Attend/run daily morning meetingsPerform weekly/monthly walkthroughs and ensure areas are maintained in a safe and compliant stateMaintaining orderliness of process area and stocking production area with suppliesDemonstrating general knowledge of aseptic techniquesPerform troubleshooting activities according to SOPsExecute routine and non-routine production operations according to MFG scheduleDocument operations according to GDP principles in Batch Production Record (BPR), Solution records (SLR), Logbooks and FormsPerform page reviews in BPRs, SLRs, Logbooks, and FormsCarry out work in a safe manner, notifying management of safety issues and risksProvide Process & Equipment Training as a Qualified TrainerMaintain up-to-date training folder for applicable processesMay be required to work at least four holidays in the calendar yearThis individual will manage equipment and support facility related projects byPerform scheduled cleaning of equipmentAssembly and disassembly of process equipmentPerform standardization of equipmentSupport equipment and process qualifications if neededEscalate work requests to Senior or Lead Technicians for submission in work request management systemWorking with supervision this individual willPropose document revisionsEscalate process improvement ideasDevelop and maintain personal development planProvide annual performance self-assessmentKNOWLEDGE, SKILLS AND EXPERIENCEEDUCATION / CERTIFICATIONS / LICENSESEssential/DesiredHS Diploma and 2-4 years related cGMP industry experienceEssentialAssociates degree in Life Sciences/Engineering field with 1 year of cGMP Manufacturing experienceDesiredBS degree in Life Sciences/Engineering fieldDesiredON-THE-JOB EXPERIENCE1+ years of relevant cleanroom GMP industry experienceEssentialAbility to adhere to company internal and regulatory (EMA, FDA) policies, processes and proceduresEssentialWorks within standard operating procedures and/or scientific methodEssentialComfortably able to lift up to 40lbsEssentialSKILLS / ABILITIESHas a process-oriented way of thinking and workingEssentialHas a flexible attitude in a challenging environmentEssentialDetail oriented and able to self-organizeEssentialAble to communicate in a professional way on diverse levels and channelsEssentialTakes the initiative to own and resolve issuesEssentialGood technical writing and oral communication skillsEssentialIntrinsically MotivatedEssentialPHYSICAL DEMANDS While performing the duties of this job, the employee is required to meet the following physical demands:Work EnvironmentRegularly required to work around equipment and typical utilities seen in pharmaceutical facilitiesOccasionally exposed to moving mechanical parts; high, precarious places; toxic or caustic chemicals; hazardous waste; and risk of electrical shockOccasionally exposed to loud noise levelsOccasionally required to do work outdoors, including roof top mechanical unitsSpending time on the floor during activity execution (maintenance, construction, commissioning and qualification) is requiredMovementFrequently required to stand; sit; walk; balance; stoop; kneel; crouch; use hands to finger, handle, or feel; reach with hands and armsOccasionally required to walk; climb or balance; and stoop, kneel, crouch, or crawlLiftingFrequently lift and/or move up to 25 poundsOccasionally lift and/or move up to 50 poundsVisionFrequently utilize close vision and the ability to adjust focusCommunicationFrequently required to communicate by talking, hearing, using telephone and e-mailGENEZEN'S CURES VALUE-BASED COMPETENCIESCommitted to ScienceWe 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 patientsWe operate with urgency and a commitment to delivering timely treatments to patients by accelerating our partners' programs.Resilience & Grit in operationsWe are committed to overcoming challenges, learning from failures, and persistently striving for success. Execute with Excellence & IntegrityWe are dedicated to delivering quality results and upholding ethical principals.Solutions driven for our partnersWe are committed to being a proactive, collaborative, creative and open-minded partner.GENEZEN'S BENEFITSPaid vacation days, amount based on tenurePaid sick time9 observed holidays + 1 floating holiday + 1 volunteer day401(k) plan with company match up to 6% of salary, vested immediatelyShare Appreciation RightsChoice of several healthcare plansFSA and HSA programsDental & vision careEmployer-paid basic term life/personal accident insuranceVoluntary disability, universal life/personal accident insuranceAccidental Death & Dismemberment (AD&D) InsuranceADDITIONAL DETAILSNothing 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. Fishers is a suburb of Indianapolis. Fishers was named the #1 place to live in the US by Money Magazine in 2017 for its livability, safety and entrepreneurship. Fishers is one of the fastest growing communities in Indiana and is dedicated to supporting a high quality of life for all its residents. Nearby Indianapolis is home to professional and college sports teams, the Indy 500, a growing art community and the world's largest children's museumto name just a few reasons why this area is a great place to live.Lexington, Massachusetts, located just northwest of Boston, is renowned as a historic suburb with a rich cultural heritage. It boasts picturesque New England charm, tree-lined streets, and a vibrant community. Known for its pivotal role in the American Revolution, Lexington offers visitors and residents alike a blend of historical landmarks, modern amenities, and a strong sense of community pride.