Scientist II, Upstream Process Development

Genezen•Lexington, MA

49d•$100,000 - $120,000

About The Position

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 Direct the development and establishment of processes in Process Development. This individual is accountable for developing a scalable platform for viral vector production processes that minimizes the risk during Process Development to GMP scale-up. The individual will provide technical expertise and leadership in science & technology and requires close collaboration with internal stakeholders.

Requirements

4-8+ years of relevant industry experience
Experience with cell culture technologies, molecular biology, upstream processing, and aseptic processing
Solid foundation in the fundamentals of biochemical engineering, virology and cell biology
Working knowledge of Upstream process (Cell culture, Aseptic Technique, bioreactor operations).

Nice To Haves

BS or MS in biochemistry, chemical engineering
Pharmaceutical industry experience in technical support of cGMP manufacturing and/or process development, including experience with Contract Development and Manufacturing Organizations
Entrepreneurial experience dealing with customers in product development
Hands-on experience on complex biologics e.g. gene therapy, transient transfection, baculovirus infection
Working knowledge of Upstream process (process design and bioreactor scale up, cGMP manufacturing).
Ability to interface successfully with multi-disciplined teams
Extremely detail-oriented with strong technical skills & mechanically inclined/knowledge of hand tools

Responsibilities

Design and execute upstream process development activities and identify opportunities to improve process yield, product safety, and product quality.
Writes and reviews experimental protocols, batch production records, experimental reports.
Analyze, review, and communicate data to senior management and team members.
Be accountable for supporting the establishment of upstream gene therapy drug substance development platform from small scale through intermediate scale (50L) for adeno-associated virus, lentiviral and retroviral vector processes.
Train and mentor research associates.
Maintain open communication via one-on-one and team meetings.
Stay current with relevant technologies and need to be adept at identifying new approaches.
Responsible for the process transfer activities from/to clients and to in-house manufacturing team(s), such as creation of bill of materials and sampling plan, generation of process description documents, technology transfer reports.Provide process training to MSAT and manufacturing teams and assist with process troubleshooting and deviations during GMP production.
Maintain external technical relationships and collaborate with equipment and material suppliers.
Serve as process SME for client-facing and internal programs.
Ensure safe working environment and compliance with OSHA, EHS, Quality, and cGMP procedures and policies within the assigned functional area.
Adaptability required as work schedule may change based on business needs
Criminal background check required
Other duties as assigned