QC Analyst II/III - Analytical

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 QC Analyst II/III will be responsible for routine and non-routine QC testing according to Standard Operating Procedures (SOPs) in a GMP laboratory. This position is based at Genezen's state-of-the-art facility in Lexington, MA. This role supports the daily and occasional 2nd shift or weekend operations within the Quality Control group via execution of analytical testing and Quality Systems. This includes but is not limited to in-process, release, and stability testing. Execution of quality systems entails deviations, corrective and preventive actions (CAPAs), investigations, Out of Specifications (OOS), and change controls. These activities are all performed in accordance with cGMP guidelines and are supported by departmental and inter-departmental policies and standard operating procedures.ESSENTIAL JOB FUNCTIONSPerform routine/non-routine testing and review of in-process, DS and DP release and stability samples in accordance with Standard Operating Procedures (q-PCR, HPLC (SEC, IEX, rpHPLC), ELISA, RI, HIAC, DLS, Osmolality, Western Blot, CE-SDS, etc.)Performs peer review as SME of assay data with minimal errors.Able to work effectively in internal/cross-functional teams as an active member.Train and execute assays cross-functionally to support deadlines for release.Participate in equipment validation, method transfer/qualification/validation, critical reagent qualification and special protocol execution as required.Responsible for protocol and report generation/revision/review, as required.Strong understanding of regulations, able to apply to any situation, and identify deficiencies w/ some guidance.Establish, revise, review and maintain standard operating procedures.Responsible for Quality Systems related to QC Operations such as identifying a deviation to procedure, perform investigation, Change Controls, CAPAs, OOSs, OOTs.Promptly and proactively communicates gaps to key stakeholders and recommends solution w/minimal guidance.Responsible for protocol and report generation/revision/review, as required.Strong understanding of regulations, able to apply to any situation, and identify deficiencies w/ some guidance.Promptly and proactively communicates gaps to key stakeholders and recommends solution w/minimal guidance.Supports internal and external audits as requiredSPECIAL JOB REQUIREMENTSAdaptability required as work schedule may change based on business needsFlexibility to support 2nd shift STAT testing as required on a monthly rotational basis. May include holidays.Criminal background check required.Other duties as assignedEDUCATION/CERTIFICATION/LICENSESBA or BS in Chemistry/Biochemistry or other related scienceON THE JOB EXPERIENCEMinimum 2-5+ years (Analyst II) and 5-8+ (Analyst III) of laboratory base experience within QC testing capacity, preferably in cGMP environment.High proficiency in HPLC methods and analysis, as well as other analytical methods.Follow procedures trained on and complete documentation applying cGMP/GDP/ALCOA+.Thorough understanding of industry testing requirements/standardsSKILLS/ABILITIESComputer literacy (MS Word, Excel, and LIMS)Good/effective communication, organizational, and critical thinking skills with the ability to work well with others and independentlyIdentify gaps and propose solutions.PAY RANGEThe annual salary range for this position is $80,000-$100,000.PHYSICAL DEMANDSWhile performing the duties of this job, the employee is required to meet the following physical demands:Work EnvironmentRegularly sit for long periods of timeMovementFrequently 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 10 poundsRarely 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 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 time10 observed holidays + 2 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 museum--to name just a few reasons why this area is a great place to live.