Drug Substance/Product Process Engineer, Tech Transfer - Biopharma (JP15405)

3 Key Consulting • Thousand Oaks, CA

13d • Hybrid

About The Position

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 internal manufacturing sites. The candidate will be 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 company products. The candidate will assist in study design, develop and execute protocols, obtain reproducible and reliable results, analyze and document experimental results, and communicate results to cross-functional groups. The candidate will also be responsible for developing and maintaining trackers for project status and other key outputs for the team.

Requirements

• 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 products / 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

Responsibilities

• 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

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level