Sr. Scientist - Analytical Development

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 SUMMARYThe Sr Scientist/Technical Lead Analytical Development will be part of the Process Development group, reporting to the Director of Process Development. He/She focuses on defining and managing the execution of the analytical development strategies and activities across the program/project lifecycle supporting process development and characterization.The Sr Scientist owns the analytical development assay lifecycle both from a technical and planning standpoint. Responsibilities will include scientific review and oversight of assay design, development, qualification, troubleshooting, and transfer as well as product characterization. The Sr Scientist will also be responsible for ensuring oversight of the analytical project timelines, and alignment across different teams and contributors to the analytical development efforts.ESSENTIAL JOB FUNCTIONSThe Sr. Scientist/Technical Lead will be a contributor to the activities of the Process Development group with specific attention toward the critical activities of the team:Developing, qualifying and transferring client/product-specific assays to be used for in-process, release testing, and process characterizationProviding analytical support to Upstream and Downstream process development team activities by ensuring consistent and timely execution of standardized platform product characterization assays, including data review, storage and trendingFacilitating integration of new products into Genezen analytical platforms, to ensure timely progress of transfers and timelinesOther Key Responsibilities & Functions:Owns the development lifecycle (method development, qualification, transfer), planning and timelines for multiple projectsResponsible for analytical strategy and timeline definition and monitoring in line with overall project timelines and functional team inputOversees the project from an analytical standpoint as core member of the project team, and has key interactions with Upstream & Downstream process development, supply chain, and external consultants and vendorsCommunicates and aligns with internal and external stakeholders’ activities relevant to specific projects planning and progressionPrepare data overviews and reports, including interpretation of results. Proposes next steps in experimental design including rational and timelinesPresents project updates, progress and results to internal and external stakeholdersDrafts or reviews laboratory and technical documentation such as SOPs, protocols, reports, position papers and memosAssist team members with their planning and coordination of activitiesEnsure all laboratory activities are performed according to applicable procedures to ensure a safe working environment and high data qualityProvide improvement suggestions and enforce improvement implementationSPECIAL JOB REQUIREMENTSAdaptability required as work schedule may change based on business needsIntent to work with the manager on meeting the company mission, vision and values to achieve department goalsCriminal background check requiredOther duties as assignedKNOWLEDGE, SKILLS AND EXPERIENCEEDUCATION / CERTIFICATIONS / LICENSESMSc with 10+ years of industrial experience in a Life Sciences related field (biochemistry, molecular biology, biotechnology)PhD with 6+ years of industrial experience in a Life Sciences related field (biochemistry, molecular biology, biotechnology)PREFERREDON-THE-JOB EXPERIENCEBroad knowledge of the pharmaceutical industry, including in depth operating knowledge of functions and assays relevant to viral vector therapeutic analytical within drug development processesDemonstrated experience in project management skills and leadership experience, including setting timelines, alignment and helping others meet timelinesSKILLS / ABILITIESThorough scientific knowledge and hands-on experience with cell-based assays and bioassays, specifically in vitro potency assaysThorough scientific knowledge and hands on experience with relevant molecular biology techniques (e.g. qPCR & dPCR, DNA electrophoresis)Thorough scientific knowledge and hands on experience with biochemical analyses (e.g. protein electrophoresis, western blotting, ELISA)Thorough scientific knowledge in the process of assay design, assay development and troubleshootingExperience in viral vaccines or gene therapyPHYSICAL DEMANDSWhile 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 gowningRegularly required to work around large machinery 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 extremely loud noise levelsSpending time on the floor during activity execution (maintenance, construction, commissioning and qualification) is requiredMOVEMENTFrequently required to stand; sit; 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 10 poundsOccasionally lift and/or move up to 25 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 COMPETENCIESC ommitted to ScienceWe 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 patientsWe operate with urgency and a commitment to delivering timely treatments to patients by accelerating our partners' programs.R esilience & Grit in operationsWe are committed to overcoming challenges, learning from failures, and persistently striving for success.E xecute with Excellence & IntegrityWe are dedicated to delivering quality results and upholding ethical principles.S olutions driven for our partnersWe are committed to being a proactive, collaborative, creative and open-minded partner.GENEZEN'S BENEFITSPaid vacation days, amount based on tenure401(k) plan with company match up to 6% of salary, vested immediatelyChoice of several healthcare plansFSA and HSA programsEmployer-paid basic term life/personal accident insuranceVoluntary disability, universal life/personal accident 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.

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