MSAT Scientist (Technology Transfer)

Thermo Fisher Scientific•Greenville, NC

About The Position

Support technology transfer activities by performing manufacturing process development for injectable products transferred to commercial lines. Use experimental design to establish formulation processes and product pathways and select components for successful scale-up. Support client calls, prepare documentation such as work orders, protocols, and summaries, provide scientific justification, and update project status as needed. Technically support day-to-day operations in the Formulation, Filling, and/or Freeze Drying areas of the Steriles plant. Work on technical and scientific process, product, and project activities to implement strategies and technical solutions. Assist in creating processes, single-use systems, and equipment designs for clinical, scale-up, and/or registration batches, including technology transfer of client projects. Make decisions involving direct application of technical knowledge. Support studies, technology transfer, commercial scale-up, and process validation. Participate in problem-solving and project results for formulations, equipment, and processes. Write or revise work orders for existing processes, FORMs, reports, memos, and protocols; support projects and implement change-control actions. Collect data for statistical analysis and support interpretation and summary of data.

Requirements

Bachelor of Science in Chemistry, Biochemistry, Biology, Pharmaceutical sciences, Engineering, or a related physical science.
Excellent knowledge of scientific methodology and development as related to the pharmaceutical industry.
Detailed knowledge of Good Manufacturing Practices (GMP).
Strong proficiency in Microsoft Office Suite, including Word, Excel, and PowerPoint.
Excellent critical and logical thinking skills.
Effective written, interpersonal, and presentation skills, including the ability to run 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.
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 up to 25 lbs. for brief periods.

Nice To Haves

Bachelor's degree and at least 1 year of related experience preferred.
Experience in a contract manufacturing organization (CMO) or pharmaceutical product development field preferred.
Equivalent combinations of education, training, and meaningful work experience may be considered.

Responsibilities

Support technology transfer activities and manufacturing process development for injectable products moving to commercial lines.
Use experimental design to establish formulation processes and product pathways and select components for scale-up.
Support client calls, prepare project documentation, provide scientific justification, and communicate project status.
Technically support day-to-day operations in the Formulation, Filling, and/or Freeze Drying areas of the Steriles plant.
Work on technical and scientific process, product, and project activities to implement strategies and technical solutions.
Assist in creating processes, single-use systems, and equipment designs for clinical, scale-up, and/or registration batches, including client technology transfers.
Support completion of studies, technology transfer, commercial scale-up, and process validation.
Participate in problem-solving and project results for formulations, equipment, and processes.
Write or revise work orders, FORMs, reports, memos, and protocols.
Support projects and implement change-control actions.
Collect data for statistical analysis and support interpretation and summary of data.