MSAT Scientist II (Technology Transfer)

Standard schedule (Mon–Fri). Work environment includes adherence to Good Manufacturing Practices (GMP) safety standards, office settings, and use of personal protective equipment (PPE) such as safety glasses, gowning, gloves, lab coat, and ear plugs.

About the role

Perform manufacturing process development for injectables products to support complete technology transfer activities to commercial lines. Using experimental design, establish formulation processes, define product pathways, and select components for successful scale-up. Support client calls, prepare documentation (work orders, protocols, summaries), and provide scientific justification and project status updates with minimal supervision.

Provide technical support for day-to-day operations in the formulation, filling, and/or freeze-drying areas of the steriles plant. Work on technical and scientific process, product, or project activities to implement strategies and solutions. Assist in creating processes, single-use systems, and equipment designs for clinical, scale-up, and registration batches, including technology transfer from clients. Make decisions involving direct application of technical knowledge.

Responsibilities

• Complete studies, technology 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, forms, reports, memos, and protocols for existing processes.
• Lead projects with moderate supervision, implement change control actions, and review and plan technical aspects to meet timelines and project goals.
• Support manufacturing operations, change controls, and investigations as a subject matter expert (SME).
• Collect and analyze data for statistical interpretation and summary.

Requirements

• Bachelor’s degree in Chemistry, Biochemistry, Biology, Pharmaceutical Science, Engineering, or a 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 is 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, 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 stay current with scientific literature and industry trends relating to process technologies.
• Ability to implement technical solutions.

Physical requirements

• Ordinary ambulatory skills and physical coordination to move about office and plant locations.
• Ability to stand and walk for extended periods.
• Ability to lift and/or carry light objects up to 25 lbs. for brief periods.