Job Description

Job Description Job Description 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 Global MSAT group plays a critical role in successful manufacturing of clinical and commercial products. The person in this role assists MSAT team in the transfer of technologies, process validation and cGMP manufacturing of Genezen's gene therapy products. JOB RESPONSIBILITIES: Lead all aspects of process technology transfer from early and late-stage process development for clinical and commercial manufacturing. Provide technical support to manufacturing and write product impact assessments to support deviations. Provide input on scope of work proposals to ensure clients' goals are met. Cross functionally collaboration with Process Development, Manufacturing, QC, QA, Engineering, Regulatory Affairs, Validation and Supply Chain as needed Ensure successful manufacturing production runs by assessing risk, setting preventative measures in place, investigating, and troubleshooting equipment and process issues. Runs client facing meetings regarding technical topics and scope of work progress Ability to provide impact assessments and aid in root-cause analysis for critical deviations and determine CAPAs for manufacturing. Author technical documentation: Protocols, and reports. Reviews executable documents: Batch records, SOPs, Assist process validation studies to develop a thorough understanding of operating and performance parameters. Support data monitoring and trending analysis using statistical process control charts. SPECIAL JOB REQUIREMENTS Ability to generate, manage, evaluate, and maintain critical data in a highly organized manner Experience with customer facing discussions Experience with statistical analysis of process data (generation and trending control charts, linear regression and multivariate analysis) KNOWLEDGE, SKILLS AND EXPERIENCE EDUCATION / CERTIFICATIONS / LICENSES Essential/Desired Bachelor's Degree in Engineering or other related scientific discipline. Essential Master's Degree in Engineering or other related scientific discipline. Desired ON-THE-JOB EXPERIENCE 6 (BS) or 4 (MS) or 0-2 (PhD) years of relevant experience in gene therapy or other biotechnology industry. Essential SKILLS / ABILITIES Experience in process development/analytical development/MSAT or GMP pharmaceutical manufacturing. Essential Good understanding of upstream and downstream processes of viral vectors, cell therapy, or recombinant biologics. Essential Ability to present to and interact with clients on behalf of the MSAT team Essential Experience developing and executing tech transfer into GMP manufacturing. Essential Ability to generate, manage, evaluate, and maintain critical data in a highly organized manner Essential Experience with statistical analysis of process data (generation and trending control charts, linear regression and multivariate analysis) Essential Strong communication skills at individual, team, and organizational levels; fluent in English, written and verbal. Essential Proven knowledge and experience of risk-based approaches to process development and validation. Essential Demonstrated sufficient knowledge and experience in cell culture and cell & virus banking. Essential Ability to cope with many topics in parallel, to cope with strict timelines and to handle pressure. Essential Ability to generate, manage, evaluate, and maintain critical data in a highly organized manner. Essential Knowledge of the current pharmaceutical, regulatory, and technology trends. Desired Knowledge of data management tools and statistical process controls. Desired 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 Occasionally 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 Pay Range: The annual salary range for this position is $115,000-$140,000 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, vested immediately 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. 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.6b250ea6-cee3-481d-915c-f7283f1b2f1b

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