R&D / Mfg Scientist III (MSAT Tech Transfer)

Thermo Fisher Scientific•Greenville, NC

About The Position

The R&D / Mfg Scientist III completes technology-transfer activities by performing manufacturing process development for injectable products moving to commercial lines. The role uses experimental design to establish formulation processes and product pathways and select components for successful scale-up. It supports client calls, prepares project documentation such as work orders, protocols, and summaries with minimum supervision, provides scientific justification, and updates project status. The position technically supports day-to-day operations in the Formulation, Filling, and/or Freeze Drying areas of the Steriles plant. It leads technical, scientific, process, product, and project activities to implement strategies and technical solutions, and drives development of processes, single-use systems, and equipment designs for clinical, scale-up, and registration batches, including client project technology transfers. The scientist makes decisions involving direct application of technical knowledge. The role designs, implements, and evaluates studies; leads technology transfer and commercial scale-up; and supports process validation. It represents the organization at formal technical and scientific forums, contributes to problem-solving and project work, and writes or revises work orders, FORMs, reports, memos, and protocols. The scientist independently manages projects, supports manufacturing operations and change controls, serves as a subject matter expert in investigations, resolves CAPAs, assesses material changes and their impact, supports proposals and timelines, leads relevant client meetings, and reviews bid quotes, protocols, technical documents, results, and reports. Work takes place in a laboratory, office, warehouse, and cold-room/freezer settings. The position requires adherence to GMP safety standards and use of PPE as needed. The schedule is standard Monday through Friday.

Requirements

Bachelor of Science in Chemistry, Biochemistry, Biology, Pharmaceutical Science, or a related physical science, or an equivalent combination of education, training, and meaningful work experience.
Three or more years of confirmed experience with a bachelor's degree.
Advanced knowledge of aspects of a subject area and working knowledge of principles and concepts in other relevant technical 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, including Word, Excel, and PowerPoint.
Excellent critical and logical thinking skills.
Effective written, interpersonal, and presentation skills, including the ability to lead technical discussions with internal and external clients.
Ability to work on multiple projects simultaneously.
Proficiency in developing 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.
Ordinary ambulatory skills and physical coordination sufficient to move about office locations; ability to stand and walk; and ability to lift or carry objects up to 25 lbs. for brief periods.
Adherence to GMP safety standards and ability to use required PPE.

Nice To Haves

CMO or pharmaceutical product development experience.

Responsibilities

Perform manufacturing process development and technology transfer 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 update project status.
Technically support day-to-day operations in the Formulation, Filling, and/or Freeze Drying areas of the Steriles plant.
Lead technical, scientific, process, product, and project activities to implement strategies and technical solutions.
Drive development of processes, single-use systems, and equipment designs for clinical, scale-up, and registration batches.
Design, implement, and evaluate studies; lead technology transfer and commercial scale-up; and support process validation.
Represent the organization at formal technical and scientific forums.
Lead or participate in problem-solving and project work involving formulations, equipment, and processes.
Write or revise work orders, FORMs, reports, memos, and protocols.
Independently manage projects and organize technical work to achieve project landmarks and turning points.
Support manufacturing operations, change controls, and investigations as a subject matter expert; resolve CAPAs.
Assess material changes and determine their impact.
Support development of project proposals and timelines and lead relevant client meetings.
Review bid quotes, protocols, technical documents, results, and reports.