Viral Vector Manufacturing Lead - DSP

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

Responsible for leading routine performance of downstream manufacturing operations including advanced laboratory techniques related to viral vector production and analytics as well as basic laboratory functions. Responsibilities and laboratory techniques required for this position include aseptic technique, preparing solutions and media, molecular biology techniques, cell culture techniques, and general cleanroom sanitization/area maintenance. The position requires working both independently and serving as the manufacturing Downstream SME for client processes, but also under the supervision of the Manufacturing Manager.

ESSENTIAL JOB FUNCTIONS

• Serve as the lead Downstream operator for coordinating team responsibilities and peforming hands on manufacturing processes related to viral vector production including downstream manufacturing tasks under the guidelines of established procedures and batch records
• Lead manufacturing activities within a team environment related to clarification, chromatography, TFF and filling activities
• Serve as a liason with downstream process development SMEs to understand the latest downstream process development processes/practices and ensure feasibility of translation of said processes/practices to a GMP manufacturing environment
• Maintain manufacturing material supply, primarily ensuring manufacturing spaces are adequately stocked and prepared
• Assist in the maintenance of laboratory equipment and laboratory support operations
• Lead in the creation, review, and revision of SOPs, batch records, and forms in coordination with management, PD and Quality Assurance
• Ensure roles and responsibilities for executing downstream manufacturing processes are clear to the operators assigned to the processes and assist with coaching/training operators as needed
• Follow detailed instructions with a high level of focus and attention to detail
• Complete documentation accurately and in a timely fashion
• Maintain up to date training status
• Use, clean, and maintain laboratory spaces and manufacturing equipment
• Lead in troubleshooting of downstream manufacturing issues, with assistance from Manufacturing Management as needed
• Train new staff members and fellow employees in all relevant downstream manufacturing processes
• Comply with all established policies and SOPs
• Perform safety inspections and maintain a safe working environment
• Use industrial equipment such as pallet jacks
• Perform area sanitization and collect/dispose of waste per established procedures
• Help collect process data for metrics/trending
• Assist in tasks required to be performed in a BSL-1, -2, or -3 environment.
• Contribute to the support, optimization, and improvements of GMP products
• Assist in specification development and review via Corrective and Preventive Actions (CAPA) and/or change controls
• Work as a team with Process Development, Quality Assurance, and other departments as needed

SPECIAL JOB REQUIREMENTS

• Adaptability required as work schedule may change based on business needs
• Criminal background check required
• Other duties as assigned

KNOWLEDGE, SKILLS AND EXPERIENCE

EDUCATION / CERTIFICATIONS / LICENSES

Essential/Desired

BS degree in Biology, Biochemistry, Molecular Biology, or similar field

Essential

ON-THE-JOB EXPERIENCE

 

Minimum 2 years of post-graduation experience in a GMP environment

Essential

2 years of experience operating in a GMP laboratory using aseptic technique and risk mitigation strategies

Essential

2 years of experience with at scale Clarification, Chromatography, and TFF platforms

Essential

Experience in cell and gene therapy DS/DP manufacturing, specifically viral vecto