Job Description

　　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. Lead client calls, prepare necessary documentation (including but not limited to work orders, protocols, summaries, with minimum supervision), and provides scientific justification as necessary and update status of project work.

　　How will you make an impact?

　　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.

　　What will you do?

　　Performs the design, evaluation and execution of formulations for pre-clinical studies, clinical trials, registration, scale-up and process validation.

　　Actively participates in problem solving and stage gates for formulations, equipment and processes.

　　Drafts quality batch production records, reports, memos and protocols as required/assigned or to support client regularly submissions

　　Leads assigned projects with a moderate level of supervision; reviews and plans all technical aspects of the project to meet appropriate timeline and achievements.

　　Review protocols, results and reports for client projects

　　Designs experiments to conduct investigations that drive to the root cause. Formulates statistics in support of data or findings.

　　Perform/co-ordinate the shipping activities of materials/In process samples, finished product to client as required for assigned projects.

　　Serves as a process SME for deviation investigations to identify the root causes of departures from standards and to assess product impact.

　　Implements corrective actions and preventive actions (CAPAs) to eliminate the root causes of deviations.

　　Monitors processes to proactively mitigate the risks of deviations and process upset situations occurring.

　　How will you get here?

　　Education:

　　Bachelor’s of Science in Chemistry, Biochemistry, Biology, Pharmaceutical or related physical science.Experience:

　　Bachelors degree in science/Pharmaceutical or related field; 3+ year of experience in a CMO or Pharmaceutical product development field.Equivalency:

　　Equivalent combinations of education, training, and relevant work experience may be considered.Knowledge, Skills, Abilities:

　　Advanced knowledge of varied aspects or a specialized aspect of a discipline and working knowledge of principles and concepts in other relevant disciplines.

　　Excellent knowledge of scientific methodology and development as related to the pharmaceutical industry.

　　Thorough 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 managing technical discussions with internal and external clients.

　　Ability to work on multiple projects simultaneously.

　　Ability to develop 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 develop 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.

　　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.