Description

• Apply fundamental engineering and scientific principles to resolve issues and evaluate effects of process improvements, equipment, scale, and raw materials.

• Assist in the design and execution of experiments to characterize and enable implementation of new capabilities and process changes such as filling, lyophilization and analytical technologies.

• Support technology transfer leads during the transfer of drug products into manufacturing sites (clinical and commercial), including make-a-batch exercises, process transfer documents, and change control assessments.

• Support development of technology transfer tools (clinical and commercial) and automation of routine activities.

• Effectively communicate results of characterization studies, experimental execution, and technology transfer initiatives.

• Author/review/data verify technical documents, such as technical protocols, technical assessments, technical reports and draft standard operating procedures

• Conduct analysis of data generated, including statistical analysis using Minitab, JMP etc.

• Development of digital tools and models by leveraging data analytics and programming skills, and AI

Preferred Qualifications:

• B.S. in engineering or biotechnology discipline with 1‒3 years’ experience or M.S. in engineering or biotechnology discipline with 0‒2 years’ experience

• Familiarity with cGMP and experience in drug product / drug substance manufacturing or process development

• Knowledge of and hands-on experience with various drug product technologies

• Displayed critical thinking, problem solving and independent research skills

• Ability to learn new techniques, perform multiple tasks, keep accurate records, follow instructions, and comply with company policies

• Excellent project management skills and ability to elevate relevant issues to project lead and line-management

• Strong cross functional team player with good communication skills (oral and written)

• Ability to work independently and as part of a team with internal and external partners

• Good computer and organizational skills with strong attention to detail

• Self-motivated with a positive attitude

Key Skills

Education

Bachelor's degree