Scientist III, Upstream Process Development

Work Schedule Standard (Mon-Fri) Environmental Conditions Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cold Room/Freezers -22degreesF/-6degrees C, Laboratory Setting, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.) Job Description As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer. DESCRIPTION: As an Upstream Process Development Scientist III, you will help our clients to deliver lifesaving therapies to patients. This position will provide direct labor within multiple work centers and will provide indirect support for projects/troubleshooting, maintenance, engineering and/or training initiatives. This is a hands-on bench scientist position. The ideal candidate shall have excellent lab skills, strong documentation skills, demonstrated ability to analyze and interpret data to draw conclusions and make recommendations, and strong collaboration and teamwork skills. As a member of the Process Development team, you will work with project leads to support the successful execution of experiments and technical transfer activities. This will include supporting the technical transfer process assessments, Pilot Plant activities and transfer into cGMP manufacturing. This will also include late-phase process characterization of viral vector manufacturing processes. What will you do? Participate in the design, planning and execution of tech transfer, process development and scale up activities (both bench and pilot scale) and preparing summary reports/presentations.  Prepare and modify documents (development plans, batch records, SOPs, protocols, summary reports), including deviation and/or investigational reports.  Serve as project lead on multiple programs with minimal direction. Manage project timelines and tasks.  Technically review data, collaborate with customers on data and experimental design, prepare documents and experiments, participate in investigations.  Serve as a SME in process development and train junior scientists.  How will you get there? Degree in biology, chemistry, biochemistry, (bio)chemical engineering, biomedical engineering, or a related field. B.S with 5+ years’ experience in a process development/manufacturing environment, Master’s with 2+ years of experience or Ph.D.  Expertise in gene therapy product and/or process development is required. Knowledge of lentivirus upstream process development is strongly preferred. Hands-on experience in aseptic technique, cell culture, stirred tank bioreactor, wave reactors and harvest/clarification operations. Experience in technical writing, GDP compliance, and data compilation/analyses.  Strong computer skills as well as ability to collect, organize, analyze, interpret and summarize complex scientific data.  Strong written and verbal communications skills; ability to interpret, summarize, and present scientific results in a clear, concise, accurate manner.  Must be a self-starter, have excellent time management, planning and organization skills.  Good knowledge of quality by design (QbD) and regulatory needs in the pharmaceutical industry, A flexible work schedule may be required, including weekends and evenings as needed to complete client work.  While performing the duties of this job, the employee: Will work in a dynamic environment and balance multiple priorities simultaneously!  Will be self-motivated and proactively drive efficient