Engineer, Drug Product Development, Process Design & Experimentation - Hybrid (JP14756)

3 Key Consulting • Thousand Oaks, CA

12d • Hybrid

About The Position

This is a hybrid position requiring 2-3 days onsite per week, with flexibility for more onsite work if necessary. The role is focused on identifying and developing aspects of drug product to advance process design for parenteral drug products. The candidate will perform experiments, organize data, and analyze results with minimal supervision. Responsibilities include establishing experimental design, developing and implementing protocols, obtaining reproducible and reliable results, analyzing data, and communicating results to cross-functional groups. This position is to supplement additional workload on the team.

Requirements

• B.S. and 2YOE in Pharma with drug product experience
• Good documentation practices (GDP)
• Experience with visual inspection
• Technical writing skills
• 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
• Experience in a matrix team environment and interacting with Analytical Sciences, Process Development, Project Management, Manufacturing, Regulatory, Compliance, and/or Quality
• Capable of organizing and communicating complex technical concepts to enable business decisions

Nice To Haves

• Experience in development/characterization of aseptic fill/finish unit operations (freeze/thaw, mixing, sterile filtration, filling, stoppering, visual inspection, etc.) to define critical process parameters
• Organizational, technical problem solving, communication (written and verbal) skills, and regular interactions
• Ability to learn and act on dynamic information at a rapid pace
• Familiar or ability to learn to use electronic record keeping, GMP, laboratory notebooks, statistical analysis and software.
• Strong knowledge of quality systems and drug product manufacturing

Responsibilities

• Supports the establishment of robust tactical and strategic objectives related to visual inspection.
• Supports ongoing development in the area of visual inspection (i.e. development and maintenance of defect panels, establishment of GMP procedures related to operations).
• Implements and documents off-line and on-site drug product characterization studies.
• Author and/or own high-quality process technology transfer and other technical documents.
• Participate in cross-functional teams working effectively in a highly matrixed team environment to drive change, efficiency, and strong relationships.
• Provide ongoing support to clinical and commercial fill/finish manufacturing operations through troubleshooting, root cause analysis, and product impact assessments for non-conformance investigations and process changes/improvements.
• Design, execute and document primary data packages related to drug product design and process development, and communicate key findings in presentations.
• Support one or more clinical and commercial process introductions or process transfers into client manufacturing network.

What This Job Offers

• Career Level: Entry Level