Engineer, Drug Product Process Development & Technology Transfer - (JP15153)

3 Key Consulting • Thousand Oaks, CA

1d • Onsite

About The Position

This position is for an Engineer, Drug Product Process Development & Technology Transfer for a consulting engagement with a leading global biopharmaceutical company. The role involves supporting senior staff in developing and characterizing drug product technologies and manufacturing capabilities, as well as assisting in process validation and technology transfer to aseptic fill finish manufacturing plants. The candidate will execute characterization studies and experiments, organize and analyze data, and interface with drug product teams to ensure successful technology transfer. The role requires establishing experimental designs, developing and executing protocols, obtaining reproducible results, analyzing and documenting experimental results, and communicating findings to cross-functional groups. The position is open to supplement additional workload on the team.

Requirements

• Bachelor's degree with at least 1 year of Industry Experience (not internship or similar).
• Solid experience with software tools beyond Microsoft Office, like SAP or Smartsheet's.
• Solid group management skills.
• Solid deadline adherence skills.
• Meticulous documentation skills.
• Strong project development (PD) and project management (PM) skills.
• Knowledge of and hands-on experience with various drug product technologies.
• Excellent project management skills and ability to escalate relevant issues to project lead and line-management.
• Ability to work independently and as part of a team with internal and external partners.
• Master degree OR Bachelor degree and 2 years of experience OR Associate degree and 6 years of experience OR High school diploma / GED and 8 years of experience.

Nice To Haves

• Candidates with a fresh master’s degree are also suitable if they bring strong soft skills.
• Technical expertise expected to develop over time.
• Familiarity with cGMP and experience in drug product / drug substance manufacturing or process development.
• 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.
• Strong cross functional team player with good communication skills (oral and written).
• 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 parameter risk assessments, process transfer documents, and change control assessments.
• Support development and maintenance of technology transfer tools (clinical and commercial).
• 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 or guideline documents.
• 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.
• Support at scale characterization and/or process validation runs as person in plant.

What This Job Offers

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