MSAT Scientist III

Thermo Fisher Scientific • Greenville, NC

5d

About The Position

As part of Thermo Fisher Scientific, the MSAT Scientist III supports work intended to help customers make the world healthier, cleaner, and safer. The role completes technology transfer activities by performing manufacturing process development for injectable products and transferring them to commercial lines. Using experimental design, the scientist establishes formulation processes and product pathways and selects components for successful scale-up. The role supports client calls, prepares documentation such as work orders, protocols, and summaries with minimal supervision, provides scientific justification, and communicates project status.

The position provides technical support for day-to-day operations in the Formulation, Filling, and/or Freeze Drying areas of the Steriles plant. It leads technical and scientific process, product, and project activities; drives development of processes, single-use systems, and equipment designs for clinical, scale-up, and/or registration batches; supports new technologies including isolator-based filling; and supports lyophilization development, cycle optimization, scale-up, and troubleshooting. The scientist makes technical decisions with minimal supervision.

The role designs, implements, and evaluates studies; leads technology transfer and commercial scale-up; and supports process validation. It represents the organization in technical and scientific forums, contributes to problem solving, independently manages projects and technical activities, supports manufacturing operations and investigations as a subject-matter expert, and provides technical guidance to less-experienced scientists as needed.

Requirements

• Bachelor’s degree in Chemistry, Biochemistry, Biology, Pharmaceutical Sciences, or a related physical science and 5+ years of relevant experience; or a master’s degree in a related scientific discipline and 4+ years of relevant experience; or a PhD in a related scientific discipline and 2+ years of relevant experience.
• Advanced knowledge of pharmaceutical process development and related technical principles.
• Excellent knowledge of scientific methodology and pharmaceutical development.
• Working knowledge of basic analytical laboratory techniques and common laboratory equipment used to support formulation and process development.
• Detailed knowledge of Good Manufacturing Practices.
• Strong critical-thinking, troubleshooting, and problem-solving skills.
• Ability to independently lead technology transfer activities and make sound technical decisions with minimal supervision.
• Ability to collaborate across functions, share knowledge, and support common project goals.
• Strong proficiency in Microsoft Office Suite, including Word, Excel, and PowerPoint.
• Effective written, interpersonal, and presentation skills, including the ability to lead technical discussions with internal and external clients.
• Ability to manage multiple projects and competing priorities.
• Ability to remain current with pharmaceutical processes, equipment, technologies, scientific literature, and relevant industry trends.
• Ordinary ambulatory skills and physical coordination sufficient to move throughout office, laboratory, and manufacturing locations; ability to stand and walk; and ability to lift and/or carry light objects up to 25 lbs. for brief periods.

Nice To Haves

• CMO/CDMO or pharmaceutical product development experience.
• Experience with technology transfer, process development, and sterile manufacturing.
• Experience with formulation and lyophilization development and troubleshooting.
• Experience with DSC, Freeze-Drying Microscopy (FDM), and SP Scientific LyoStar or similar development-scale lyophilization systems.
• Experience with isolator technology, PFS, cartridge filling, two-compartment cartridge systems, and/or Media Fill.
• Equivalent combinations of education, training, and meaningful work experience may be considered.

Responsibilities

• Complete technology transfer activities for injectable products, including manufacturing process development and transfer to commercial lines.
• Use experimental design to establish formulation processes and product pathways and select components for scale-up.
• Support client calls, prepare work orders, protocols, summaries, and other documentation with minimal supervision, provide scientific justification, and communicate project status.
• Provide technical support for day-to-day operations in the Formulation, Filling, and/or Freeze Drying areas of the Steriles plant.
• Lead technical and scientific process, product, and project activities to implement strategies and solutions.
• Drive creation of processes, single-use systems, and equipment designs for clinical, scale-up, and/or registration batches.
• Support development and implementation of new technologies, including isolator-based filling.
• Support lyophilization development, cycle optimization, scale-up, and troubleshooting.
• Design, implement, and evaluate studies; lead technology transfer and commercial scale-up; and support process validation.
• Represent the organization in formal technical and scientific forums.
• Lead or participate in problem-solving activities related to formulations, equipment, and manufacturing processes.
• Write and revise work orders, FORMs, reports, memos, and protocols as required.
• Independently manage projects and organize technical activities to achieve key milestones.
• Support manufacturing operations, change controls, and investigations as a subject-matter expert, and develop appropriate CAPAs.
• Assess material and process changes and determine their potential impact.
• Support development of proposals and project timelines and lead relevant client meetings.
• Review bid quotes, protocols, technical documents, results, and reports.
• Provide technical guidance to less-experienced scientists as needed.

What This Job Offers

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