MSAT Scientist II

Standard office hours (40 hours per week). Work environment is primarily office-based with some requirement for personal protective equipment (PPE) such as safety glasses, gowning, gloves, lab coat, and ear plugs.

About the Role

Complete Technology Transfer activities by performing manufacturing process development for Injectables products to commercial lines. Using experimental design, establish formulation processes, product pathways, and select components for successful scale-up. Support client calls, prepare documentation (including work orders, protocols, summaries) with minimal supervision, and provide scientific justification while updating project status 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.

Responsibilities

• Complete studies, tech transfer, commercial scale-up, and support process validation.
• Represent the organization in internal technical discussions.
• Actively participate in problem-solving and project results for formulations, equipment, and processes.
• Write and revise work orders for existing processes, forms, reports, memos, and protocols.
• Lead projects with a moderate level of supervision, implement change control actions, review, and plan technical aspects of the project to meet timelines and goals.
• Support manufacturing operations, change controls, and investigations as a subject matter expert (SME).
• Collect data for statistical analysis and support interpretation and summary of data.

Requirements

• Bachelor’s of Science in Chemistry, Biochemistry, Biology, Pharmaceutical, Engineering, or related physical science.
• Bachelor’s degree with 2+ years of related experience, or a related Master’s degree.
• Experience in a CMO or Pharmaceutical product development field preferred.
• Equivalent combinations of education, training, and meaningful work experience may be considered.

Skills

• 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, walk, and lift/carry light objects up to 25 lbs. for brief periods.