QC Analyst - Bioassay (Temporary, 2nd shift, Wed-Sat)

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 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 The QC Analyst will be responsible for routine and non-routine QC testing within the Bioassay team within a GMP laboratory.  This is a 2 nd shift, Wednesday-Saturday, fully on-site, position (1 – 11.30pm) based at Genezen’s new state-of-the-art facility in Lexington, MA.  This role supports daily operations within the Quality Control group through execution of cell-based testing, routine lab support and working within Quality Systems. This includes but is not limited to in-process testing, lot release testing, and stability testing. Support outside of standard shift hours is required occasionally and the initial work period will be on Mon-Fri. All activities are executed in accordance with cGMP guidelines and are supported by departmental and inter-departmental policies and standard operating procedures.  ESSENTIAL JOB FUNCTIONS  Perform routine/non-routine cell-based testing and review of in-process, DS and DP release and stability samples in accordance with Standard Operating Procedures (q-PCR, ddPCR, cell culture, ELISA) Perform peer review as SME of assay data with minimal errors.  Participate in equipment validation, method transfer/qualification/validation, critical reagent qualification and special protocol execution as required.  Review/generate protocols and reports, as required.  Establish, revise, review and maintain standard operating procedures.  Promptly and proactively communicates gaps to leadership Work as an active member of internal/cross-functional teams Train other analysts, as required.  SPECIAL JOB REQUIREMENTS Strong understanding of GxP regulations, ability to apply to any situation, and identify deficiencies w/ some guidance.    Adaptability required as work schedule may change based on business needs. Criminal background check required (completion by staffing agency satisfies this requirement). Other duties as assigned. KNOWLEDGE, SKILLS AND EXPERIENCE EDUCATION / CERTIFICATIONS / LICENSES Essential/Desired BA/BS in Biochemistry/Cell Biology or other related science Essential ON-THE-JOB EXPERIENCE Minimum 2 years’ laboratory base experience within QC testing capacity, preferably in cGMP environment. Essential Thorough understanding of industry testing requirements/standards Essential SKILLS / ABILITIES Computer literacy (MS Word, Excel, and LIMS) Essential Good/effective communication and organizational skills with the ability to work well with others and independently. Essential PAY RATE: This position is being filled through a third-party staffing agency and is a temporary assignment. The anticipated hourly pay range for this position is $30 - $40 per hour, based on qualifications, skills, experience, and other job-related factors. PHYSICAL DEMANDS  While performing the duties of this job, the employee is required to meet the following physical demands: Work Environment Regularly sit for long periods of time Movement Frequently required to stand; sit; 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 10 pounds Rarely lift and/or move up to 25 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 Paid sick time 10 observed holidays + 2 floating holiday + 1 volunteer day 401(k) plan with company match up to 6% of salary Share Appreciation Rights Choice of several healthcare plans FSA 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.