Manufacturing Scientist II (Technology Transfer)
📋 Role Overview & Responsibilities
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 provides scientific justification and update status of project work as needed.
Discover Impactful Work!
Technically supports day-to-day operations in the Formulation, Filling, and/or Freeze Drying areas of the Steriles plant.May be involved in clinical stage of drug development.Works on technical/scientific process/product/project activities to implement strategies and technical solutions that meet client needs and expectations.Assists in the creation of processes and equipment design for clinical, scale up, and/or registration batches, including technology transfer of projects to and from clients.Evaluates and contributes to the design of manufacturing processes and supports problem solving as necessary within defined procedures and practices.Makes decisions that involve direct application of technical knowledge.
A Day in the Life.
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 as the need arises.Lead projects with a moderate level of supervision, execute change control actions, review and plans technical aspects of the project to meet timeline and milestones.Support manufacturing operations, change controls, investigations as subject matter expert (SME), determine accurate CAPAs.Collects data for statistical analysis. Can support interpretation and summary of data.
Keys to Success
Education
Bachelor’s of Science in Chemistry, Biochemistry, Biology, Pharmaceutical or related physical science.
Experience
Bachelors and 2+ years of related experience, or, related Master’s degree.Experience in a CMO or Pharmaceutical product development field PREFERRED
Equivalency
Equivalent combinations of education, training, and meaningful work experience may be considered.
Knowledge, Skills, Abilities
Advanced knowledge of multifaceted aspects or a specialized aspect of a subject area and working knowledge of principles and concepts in other relevant subject areas.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, and PowerPoint). Excellent critical and logical thinking skills.Effective written, interpersonal, and presentation skills, including running technical discussions with internal and external clients.Ability to work on multiple projects simultaneously.Ability to acquire knowledge and skills in pharmaceutical processes, equipment, instrumentation, and procedures.Ability to keep current with scientific literature and industry trends relating to process technologies.Ability to run technical solutions.Position requires ordinary ambulatory skills and physical coordination sufficient to move about office locations; ability to stand and walk; ability to lift and/or carry light objects of up to 25 lbs. for brief periods.
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Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
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