Process Development, Data Scientist II

Job Title:  Data Scientist II, Process Development  

Department: Process Development - Downstream   

 

 

About the Role: 

The Process Development, Data Scientist II will provide active leadership and execution of the data analysis and documentation improvements for downstream process development efforts. This individual will be responsible for leading data science initiatives within the team, driving data science projects from conception to implementation, set up procedures, manage junior scientists, foster innovation within the process development department to advance viral vector manufacturing process. This role provides an opportunity to play a significant impact in the success of client gene therapy programs. 

 

What You'll Do: 

• Focus on extracting insights from production data to identify areas for improvement, predict potential issues, drive efficiency, automate data pipelines, and create insightful dashboards to support development and manufacturing.  

• Lead data structuring, perform data analysis to build data trends and patterns, model development, and statistical analysis. 

• Ensure innovative technologies and methodologies are employed to maintain the highest data quality standards while ensuring that activities occur in an efficient and GDP-compliant manner.  

• Generate reports and contribute to responses to both internal and external stakeholders. 

• Independently present results, work with cross-functional teams where necessary to prepare publications or reports in alignment with key stakeholders. 

• Become a subject matter expert (SME) for our electronic lab notebook system, Benchling, our documentation and training system, Quality Management System (Veeva). 

• Work closely with process development scientists to apply advanced data analytical techniques to understand and optimize the manufacturing process.  

• Providing training to process development team members on data science and analytics including but not limited to the training curriculum. 

• Review study protocols, and technical reports and approve documentation.  

• Ensure reports are written to highest standards and manage documentation review and approvals to meet deadlines. 

• Ensure data is maintained in an accurate and controlled manner. 

• Support internal process transfer activities from Process Development to GMP. 

• Provide training, leadership, and guidance to the team, share resources on best practices, and provide feedback.  

• Effectively manage a team of Data Scientists to support process development needs.  

• Provide technical guidance and mentorship to junior team members, promoting their personal growth and skill development. 

• Collaborate closely with process development scientists, Manufacturing Sciences and Technology, cGMP, Compliance and Information technology teams to manage on the projects while adhering to relevant standards and company guidelines during product lifecycle. 

  

What You'll Bring: 

• Bachelor’s degree in chemical engineering, Biomedical Engineering, Biology or related discipline (or equivalent experience) with a minimum of 10 years' experience. 

• Experience in Data Science, Data Analytics, Data Engineering, or related discipline certification, or relevant coursework are a plus. 

• Working knowledge of purification techniques such as chromatography, tangential flow filtration, clarification etc. is a plus. 

• Understanding of manufacturing processes relevant to the industry (e.g., chemical engineering, pharmaceutical production) 

• Knowledge of process control methodologies and quality standards. 

• Proven ability to operate and troubleshoot purification equipment.