QC Technical Services Analyst II/III

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. JOB SUMMARY The individual in this role will work collaboratively with the analytical development, quality control, and quality assurance teams to support successful transfer and implementation of QC analytical methods for the testing of viral vectors and gene therapy products in support of Genezen’s services and commercial products. The role includes executing assays, training personnel, managing materials, and generating documentation in compliance with cGMP standards and regulatory guidelines. Additionally, the role contributes to critical material and method lifecycle management and documentation. ESSENTIAL JOB FUNCTIONS Support the implementation and technology transfer of QC analytical methods, including assay execution, personnel training, procurement of materials and reagents, documentation generation, and facilitation of knowledge transfer. Execute Performance Qualification (PQ) activities for new equipment. Compile and analyze data to support tech transfer and method implementation. Draft and revise equipment operational SOPs and method SOPs/worksheets in accordance with cGMP. Receive training on new analytical methods and support assay execution during tech transfer. Conduct QC Operations training for new methods and equipment. Manage Bill of Materials (BOM) creation and coordinate procurement for tech transfer activities. Critical Material Management Lead inventory maintenance of critical materials, including freezer mapping and QC handoffs. Support lifecycle management of critical materials, including qualification/re-qualification and COA review and generation. Assist with data trending and compilation of trend reports. Method Life Cycle and Documentation Support drafting of protocols and reports for QC method transfer, qualification, verification, and validation. Review, revise, and maintain procedures, including protocols and technical reports. Assist in lifecycle maintenance of laboratory procedures and SOP updates. Support QMS related activities by generating documentation to support change controls/deviations/investigations in eDMS systems. Assist in assay troubleshooting and support continuous improvement initiatives. 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 EXPERIENCE EDUCATION / CERTIFICATIONS / LICENSES BS or higher degree in Biology, Biochemistry, Molecular Biology or related Life Sciences ON-THE-JOB EXPERIENCE 5+ years of relevant industry experience in QC 2+ years of relevant experience with gene Therapy/Viral vector production Desired SKILLS / ABILITIES Experience with laboratory techniques (qPCR, ddPCR, ELISA, cell based assays etc.) Computer/software literacy (MS Word, Excel, JMP, Minitab, and LIMS etc.) Ability to thrive in a quickly changing, CDMO environment where flexibility and teamwork is essential Ability to work in a fast-paced, collaborative environment, and able to manage workload based on changing priorities Experience with technical writing skills such as protocol, reports, procedures etc. Good/effective communication and organizational skills with the ability to work well with others and independently Ability to work collaboratively with cross functional departments PHYSICAL DEMANDS While performing the duties of this job, the employee is required to meet the following physical demands: Regularly sit for long periods of time Movement Frequently 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 Lifting Frequently lift and/or move up to 10 pounds Rarely lift and/or move up to 25 pounds Vision 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 401(k) plan with company match up to 6% of salary, vested immediately Choice of several healthcare plans FSA and HSA programs Employer-paid basic term life/personal accident insurance Voluntary disability, universal life/personal accident insurance ADDITIONAL DETAILS 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: Fishers, Indiana and Lexington, Massachusetts. Fishers is a suburb of Indianapolis. Fishers was named the #1 place to live in the US by Money Magazine in 2017. Lexington, Massachusetts is a historic suburb with a blend of historical landmarks and modern amenities. Create a Job Alert

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