MSAT Scientist (Technology Transfer)
About The Position
Support Technology Transfer activities by performing manufacturing process development for Injectables products to commercial lines. Using experimental design, establish formulation processes, product pathway and select components for successful scaleup. Support client calls, prepare documentation (including but not limited to work orders, protocols, summaries), and provides scientific justification and update status of project work as needed. Technically supports day-to-day operations in the Formulation, Filling, and/or Freeze Drying areas of the Steriles plant. Works on technical/scientific process/product/project activities to implement strategies and technical solutions. Assists in the creation of processes, single use systems, and equipment designs for clinical, scale up, and/or registration batches, including technology transfer of projects from clients. Makes decisions that involve direct application of technical knowledge. Support completion of studies, tech transfer, commercial scale-up and support process validation. Actively participate in problem solving and project results for formulations, equipment and processes. Write/revise work orders for existing processes, FORMs, reports, memos, and protocols. Support projects, implement change control actions. Collects data for statistical analysis. Can support interpretation and summary of data.
Requirements
- Bachelor’s of Science in Chemistry, Biochemistry, Biology, Pharmaceutical, Engineering or related physical science.
- 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 (Word, Excel, and PowerPoint).
- Excellent critical and logical thinking skills.
- Effective written, interpersonal, and presentation skills, including running technical discussions with internal and external clients.
- Ability to work on multiple projects simultaneously.
- Ability to acquire knowledge and skills in pharmaceutical processes, equipment, instrumentation, and procedures.
- Ability to keep current with scientific literature and industry trends relating to process technologies.
- Ability to run technical solutions.
- Ordinary ambulatory skills and physical coordination sufficient to move about office locations; ability to stand and walk; ability to lift and/or carry light objects of up to 25 lbs. for brief periods.
Nice To Haves
- 1+ year of related experience PREFFERED.
- Experience in a CMO or Pharmaceutical product development field PREFERRED.
Responsibilities
- Support Technology Transfer activities by performing manufacturing process development for Injectables products to commercial lines.
- Establish formulation processes, product pathway and select components for successful scaleup using experimental design.
- Support client calls, prepare documentation (including but not limited to work orders, protocols, summaries), and provides scientific justification and update status of project work as needed.
- Technically supports day-to-day operations in the Formulation, Filling, and/or Freeze Drying areas of the Steriles plant.
- Works on technical/scientific process/product/project activities to implement strategies and technical solutions.
- Assists in the creation of processes, single use systems, and equipment designs for clinical, scale up, and/or registration batches, including technology transfer of projects from clients.
- Makes decisions that involve direct application of technical knowledge.
- Support completion of studies, tech transfer, commercial scale-up and support process validation.
- Actively participate in problem solving and project results for formulations, equipment and processes.
- Write/revise work orders for existing processes, FORMs, reports, memos, and protocols.
- Support projects, implement change control actions.
- Collects data for statistical analysis.
- Can support interpretation and summary of data.
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
