Senior Scientist-Process Analytical Technology – Cell & Gene Therapy

Senior Scientist-Process Analytical Technology – Cell & Gene Therapy

Requirements

• Hands-on experience with evaluating and/or implementing PAT tools for real-time monitoring of bioreactor.
• Experience using ML such as PCA, PLS, and clustering methods.
• Experience developing and deploying chemometric models for quantitative analysis of bioreactor status.
• Proficiency with scripting languages such as Matlab, Python or R and analytical softwares such as JMP, SIMCA, Unscrambler, etc.
• Familiarity with data visualization tools such as PowerBI, Spotfire.
• Understanding of bioprocessing, cell and gene therapy process development, characterization, and manufacturing.
• Ability to use literature to design proof of concept studies.
• Experienced writing technical documents including development reports, qualification protocols and qualification reports.
• Excellent communication and presentation skills with the proven ability to solve complex problems and to work effectively as a member of a multidisciplinary team, detail oriented, multitasking, goal and timeline oriented, and critical thinker.
• Team player, innovative, collaborative, and initiative.
• Ph.D in Materials Science, Physics, Analytical Chemistry, Chemical Engineering or related discipline with 2+ years of industry experience or an MS with 5+ years of industry experience.

Responsibilities

• Evaluate and develop analytical methods for real-time monitoring of cell therapies using enabling technologies and traditional process analytical technologies.
• Evaluate and develop on-line, in-line, or at-line analytical methods for process monitoring, in-process analytics, and process characterization.
• Develop, qualify/validate and implement spectroscopic methods (Raman, NIR, FTIR) either in non-GMP and GMP environment for process monitoring of biologics and cell therapy processes such as mAbs, proteins, viral vaccines, cell or gene therapy. Preferred experience with cell therapy products.
• Develop, qualify/validate and implement biocapacitance and other novel cell density monitoring platforms either in non-GMP and GMP environment for biologics or cell and gene therapy. Experience in cell therapy is a plus.
• Develop assay design criteria using Design of Experiments (DOE) and other contemporary development tools.
• Experience with in-line probes, such as capacitance and Raman spectroscope, and development of statistical and regression models using advanced data analytics.
• Experience developing at-line or online methods using process automation, miniaturization, or high-throughput analytics.
• Experience in implementing RAMAN, Biocapacitance and other PAT tool in the GMP environment for biologics or cell and gene therapy.
• Experience in professional capacity developing soft sensors and statistical process models using data science approaches such as ML and AI.
• Familiarity or experience with robotic liquid handlers such as TECAN or Hamilton, and AMBR bioreactor system, BRX and their associated scripting software.
• Maintain excellent written documentation (e.g. lab notebook and test forms).
• Collaborate internally with process development and manufacturing teams to evaluate and test novel real-time monitoring technologies.

Preferred Qualifications

No preferred qualifications provided.