MSAT Scientist III
About The Position
The MSAT 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 documentation such as work orders, protocols, and summaries with minimal supervision, provides scientific justification as needed, 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 and scientific process, product, and project activities; develops processes, single-use systems, and equipment designs for clinical, scale-up, and/or registration batches; and transfers client projects. The role applies technical knowledge to decisions, independently manages projects, and supports manufacturing operations, change controls, investigations, and corrective and preventive actions.
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.
- At least 5 years of confirmed experience with a bachelor's degree.
- Advanced knowledge of multiple aspects of a subject area and working knowledge of principles and concepts in related 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 light objects up to 25 lbs. for brief periods.
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 technical aspects to achieve project milestones and turning points.
- Support manufacturing operations, change controls, and investigations as a subject matter expert, and 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, and update project status.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
