Overview Manufacturing Scientist II (Technology Transfer) role at Thermo Fisher Scientific. Job Overview Complete Technology Transfer activities by performing manufacturing process development for Injectables products to commercial lines. Using experimental design, establish formulation processes, product pathway and select components for successful scaleup. Support client calls, prepare documentation (including but not limited to work orders, protocols, summaries), with minimum supervision, and provide scientific justification and status updates of project work as needed. Responsibilities Technically support day-to-day operations in the Formulation, Filling, and/or Freeze Drying areas of the Steriles plant. Work on technical/scientific process/product/project activities to implement strategies and technical solutions. Assist in the creation of processes, single use systems, and equipment designs for clinical, scale-up, and/or registration batches, including technology transfer of projects from clients. Make decisions that involve direct application of technical knowledge. Complete studies, tech transfer, commercial scale-up and support process validation. Represent the organization on internal technical discussions. Actively participate in problem solving and project results for formulations, equipment and processes. Write/revise work orders for existing processes, FORMs, reports, memos, and protocols. Lead projects with a moderate level of supervision, implement change control actions, review and plan technical aspects of the project to meet timeline and project goals. Support manufacturing operations, change controls, investigations as subject matter expert (SME). Collect data for statistical analysis and support interpretation and summary of data. Qualifications Education: Bachelor’s of Science in Chemistry, Biochemistry, Biology, Pharmaceutical, Engineering or related physical science. Experience: Bachelor’s and 2+ years of related experience, or related Master’s degree. Experience in a CMO or Pharmaceutical product development field is PREFERRED. Equivalency: Equivalent combinations of education, training, and meaningful work experience may be considered. Knowledge, Skills, Abilities: Excellent knowledge of scientific methodology and development as related to the pharmaceutical industry; detailed knowledge of Good Manufacturing Practices; strong proficiency in Microsoft Office Suite (Word, Excel, PowerPoint); excellent critical and logical thinking skills; effective written, interpersonal, and presentation skills; ability to work on multiple projects; ability to acquire knowledge in pharmaceutical processes, equipment, instrumentation, and procedures; ability to keep current with scientific literature and industry trends; ability to run technical solutions; ordinary ambulatory skills and physical coordination to move about office locations; ability to stand and walk; ability to lift and/or carry light objects up to 25 lbs. for brief periods. Employment type Full-time Job function Research, Science, and Engineering Industries Pharmaceutical Manufacturing and Biotechnology Research Notes: Referrals may increase interviewing chances. This posting reflects the information provided and does not include non-essential site notices. #J-18808-Ljbffr Thermo Fisher Scientific
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