MSAT Scientist III
About The Position
The MSAT Scientist III completes technology transfer activities by developing manufacturing processes for injectable products and transferring them to commercial lines. The role uses experimental design to establish formulation processes and product pathways and select components to support 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 work in the Formulation, Filling, and/or Freeze Drying areas of the Steriles plant. 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 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. Responsibilities also include designing and evaluating studies, leading technology transfer and commercial scale-up, supporting process validation, representing the organization in technical forums, managing projects and technical milestones, and supporting manufacturing operations as a subject matter expert. The scientist assesses material and process changes, supports investigations and CAPAs, contributes to proposals and timelines, leads relevant client meetings, reviews technical documents and results, and provides guidance to less-experienced scientists as needed. The work is performed in accordance with GMP safety standards.
Requirements
- Bachelor’s degree in Chemistry, Biochemistry, Biology, Pharmaceutical Sciences, or a related physical science with 6 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 PhD 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 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.
Responsibilities
- Complete technology transfer activities by developing manufacturing processes for injectable products and transferring them 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, 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 the creation of processes, single-use systems, and equipment designs for clinical, scale-up, and/or registration batches.
- Support 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 proposal development 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.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
