Sr. Scientist - Analytical Development

The field of gene therapy is growing rapidly and Genezen is here to meet the exacting needs of our clients. We provide process development, produce GMP viral vectors, and provide cell transduction for gene and cell therapy clinical trials and are proud to be a part of the process that leads to new cures. 

WORKING AT GENEZEN

Many people have worked in environments where you feel like just another nameless part of an enormous machine. Genezen is different. We want our employees to be innovative, collaborative problem solvers who are dedicated to meeting the challenges of working at a fast-growing company. We are dedicated to empowering our employees to be their best and making Genezen a rewarding place to work. Every employee contributes to the success of the company and you can be part of that team.

JOB SUMMARY

 

The Sr Scientist/Technical Lead Analytical Development will be part of the Process Development group, reporting to the Director of Process Development. He/She focuses on defining and managing the execution of the analytical development strategies and activities across the program/project lifecycle supporting process development and characterization. 

The Sr Scientist owns the analytical development assay lifecycle both from a technical and planning standpoint. Responsibilities will include scientific review and oversight of assay design, development, qualification, troubleshooting, and transfer as well as product characterization. The Sr Scientist will also be responsible for ensuring oversight of the analytical project timelines, and alignment across different teams and contributors to the analytical development efforts. The Sr Scientist is also responsible for management, training, and mentorship of junior Scientists and Associates within the Analytical Development team.  

 

ESSENTIAL JOB FUNCTIONS

The Sr. Scientist/Technical Lead will be a contributor to the activities of the Process Development group with specific attention toward the critical activities of the team:  

• Developing, qualifying and transfer of client/product-specific assays to be used for in-process, release testing, and process characterization 
• Providing analytical support to Upstream and Downstream process development team activities by ensuring consistent and timely execution of standardized platform product characterization assays, including data review, storage and trending
• Facilitating integration of new products into Genezen analytical platforms, to ensure timely progress of transfers and timelines
• AD team leadership including training, development and mentoring
• Owns the development lifecycle (method development, qualification, transfer), planning and timelines for multiple projects
• Responsible for analytical strategy and timeline definition and monitoring in line with overall project timelines and functional team input
• Oversees the project from an analytical standpoint as core member of the project team, and has key interactions with Upstream & Downstream process development, supply chain, and external consultants and vendors
• Communicates and aligns with internal and external stakeholders’ activities relevant to specific projects planning and progression
• Prepare data overviews and reports, including interpretation of results. Proposes next steps in experimental design including rational and timelines
• Presents project updates, progress and results to internal and external stakeholders
• Drafts or reviews laboratory and technical documentation such as SOPs, protocols, reports, position papers and memos
• Assist team members with their planning and coordination of activities
• Ensure all laboratory activities are performed according to applicable procedures to ensure a safe working environment and high data quality
• Provide improvement suggestions and enforce improvement implementation 

SPECIAL JOB REQUIREMENTS

• Adaptability required as work schedule may change