As a member of the process development team, the candidate will be focused on supporting senior staff to develop and characterize drug product technologies and manufacturing capabilities, as well as assist in the process validation and technology transfer of multiple products to various aseptic fill finish manufacturing plants and production lines. The candidate will support senior staff in the planning, execution and documentation of characterization, process validation and technology transfer projects. The candidate will be primarily responsible for executing characterization studies and other experiments at the lab scale and production scale to generate technical data packages using complex technology, while organizing data and analyzing results under supervision of senior staff. The candidate will be responsible for liaising with various drug product teams to ensure successful technology transfer, with associated documentation, of products. The candidate will assist to establish the experimental design, develop and execute protocols, obtain reproducible and reliable results, analyze and document experimental results, and communicate results to cross functional groups.

Top Skills:

• Masters Degree HIGHLY PREFERABLE

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

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

Basic Qualifications:

• Master’s degree OR Bachelor's Degree and 2 years of relevant experience
• Preferred Qualifications/Educational background in Chemical Engineering, Biomedical Engineering, Biotechnology correlated technical field of study in biotechnology, life sciences or related discipline.
• Knowledge in scientific principles of freeze/thaw, formulation/mixing, filtration, filling, lyophilization, capping, and visual inspection.
• Ability to work on multiple projects simultaneously, learn new techniques, keep accurate records, follow SOP’s and instructions in compliance with company policies, and comfortable to operate in a very flexible, agile environment
• Ability to independently design and execute characterization studies, author characterization protocols, process transfer documents, application notes and technical reports.
• Proficiency in technical problem solving, critical thinking, and delivery of technical solutions with some oversight
• Strong knowledge of Quality systems and Drug Product Manufacturing (GMP).
• Demonstrated ability to use interpersonal skills to build strong technical relationships.
• Self-motivation, adaptability, and a positive attitude.
• Excellent communication skills, both oral and written.

Responsibilities include, but are not limited to, the following:

• 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 in order 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)

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

• Author/review 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