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

Thermo Fisher Scientific • Greenville, NC

3d

About The Position

As part of Thermo Fisher Scientific, the R&D / Mfg Scientist III supports technology transfer and manufacturing process development for injectable products moving to commercial lines. The role uses experimental design to establish formulation processes and product pathways and to select components that support successful scale-up. It also supports client calls, prepares project documentation with minimal supervision, provides scientific justification as needed, and communicates project status.

The position technically supports day-to-day operations in the Steriles plant’s Formulation, Filling, and/or Freeze Drying areas. It leads technical and scientific process, product, and project activities, including development of processes, single-use systems, and equipment designs for clinical, scale-up, and registration batches, as well as client project technology transfers. The scientist makes decisions through direct application of technical knowledge and independently manages project technical work to meet milestones.

The work takes place in a laboratory, office, and warehouse environment, with possible work in cold rooms and freezers. GMP and safety standards must be followed, and some personal protective equipment is required. The posting also describes lifting up to 40 lbs. without assistance in its environmental conditions; elsewhere it states the position requires the ability to lift or carry objects up to 25 lbs. for brief periods.

Requirements

• Bachelor’s degree in Chemistry, Biochemistry, Biology, Pharmaceutical Science, or a related physical science, or an equivalent combination of education, training, and meaningful work experience.
• At least 3 years of confirmed experience with a bachelor’s degree.
• Advanced knowledge of a variety 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 stay current with scientific literature and industry trends related 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; ability to lift or carry objects up to 25 lbs. for brief periods.
• Ability to lift 40 lbs. without assistance, as specified under environmental conditions.
• Ability to adhere to GMP and safety standards and use required personal protective equipment.

Nice To Haves

• CMO or pharmaceutical product development experience.

Responsibilities

• 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 for new processes as required.
• Independently manage projects and organize their technical aspects to achieve milestones 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.
• Support client calls, prepare project documentation, provide scientific justification as needed, and update project status.
• Support day-to-day operations in the Steriles plant’s Formulation, Filling, and/or Freeze Drying areas.
• Develop manufacturing processes and formulations for injectable products and select components to support commercial scale-up.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level