MSAT Scientist I

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 scale-up. Support client calls, prepare documentation (including but not limited to work orders, protocols, summaries), and provide scientific justification and update status of project work as needed.

Responsibilities

• Support completion of studies, tech transfer, commercial scale-up, and 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 and implement change control actions.
• Collect data for statistical analysis and support interpretation and summary of data.
• Technically support day-to-day operations in the Formulation, Filling, and/or Freeze Drying areas of the Steriles plant.
• Work on technical/scientific process/product/project activities to implement strategies and technical solutions.
• Assist 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.

Requirements

• Bachelor’s of Science in Chemistry, Biochemistry, Biology, Pharmaceutical, Engineering, or related physical science.
• 1+ year of related experience (preferred).
• Experience in a CMO or Pharmaceutical product development field (preferred).
• Equivalent combinations of education, training, and meaningful work experience may be considered.
• Excellent knowledge of scientific methodology and development as related to the pharmaceutical industry.
• Detailed knowledge of Good Manufacturing Practices (GMP).
• 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.
• 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.

Environmental Conditions

• Office environment.
• Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs, etc.).

Schedule

Standard office hours (40 hours per week).