MSAT Scientist III

Thermo Fisher Scientific•Greenville, NC

About The Position

The MSAT Scientist III completes technology transfer activities by performing manufacturing process development for injectable products and transferring them to commercial lines. The role uses experimental design to establish formulation processes and product pathways and select components for successful scale-up. The scientist 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 Steriles plant’s Formulation, Filling, and/or Freeze Drying areas. It leads technical and scientific process, product, and project activities; helps create processes, single-use systems, and equipment designs for clinical, scale-up, and/or registration batches; supports implementation of new technologies, including isolator-based filling; and contributes to lyophilization development, cycle optimization, scale-up, and troubleshooting. The role makes sound technical decisions with minimal supervision. The scientist designs, implements, and evaluates studies; leads technology transfer and commercial scale-up; and supports process validation. The position represents the organization in technical and scientific forums, addresses formulation, equipment, and manufacturing-process problems, prepares and revises technical documents, and independently manages projects and milestones. It also supports manufacturing operations, change controls, investigations, and CAPA development; assesses the impact of material and process changes; contributes to proposals and timelines; leads client meetings; reviews technical and commercial documents; and provides guidance to less-experienced scientists as needed. The work schedule is standard Monday through Friday. The working environment includes office work and adherence to Good Manufacturing Practices (GMP) safety standards, with movement among office, laboratory, and manufacturing locations.

Requirements

Bachelor’s degree in Chemistry, Biochemistry, Biology, Pharmaceutical Sciences, or a related physical science with 5 or more years of relevant experience; or a master’s degree in a related scientific discipline with 4 or more years of relevant experience; or a Ph.D. in a related scientific discipline with 2 or more 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.
Ability to move throughout office, laboratory, and manufacturing locations, stand and walk, and lift or carry light objects up to 25 pounds 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

Technically support 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.
Create 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.
Complete technology transfer and manufacturing process development for injectable products, including transfer to commercial lines.
Use experimental design to establish formulation processes and product pathways and select components for successful scale-up.
Support client calls, prepare project documentation and scientific justifications, and communicate project status.