Scientist I/II, Downstream Process Development

Genezen•Lexington, MA

47d•$85,000 - $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

2-8+ years of relevant industry experience
Solid foundation in the fundamentals of biochemical engineering, virology and cell biology
Experience with industry standard chromatography and filtration methods
Ability to hypothesize and drive key experiments for internal and external programs
Working knowledge of AKTAs and UNICORN software

Nice To Haves

BS or MS in biological engineering
Entrepreneurial experience dealing with customers in product development
Pharmaceutical industry experience in technical support of cGMP manufacturing and/or process development, including experience with Contract Development and Manufacturing Organizations
Experience with cell culture technologies, molecular biology, upstream processing, and aseptic processing
Understanding of analytical assays used in the characterization of biologics
Familiar with tangential flow filtration skids
Ability to interface successfully with multi-disciplined teams.
Extremely detail-oriented with strong technical skills & mechanically inclined/knowledge of hand tools

Responsibilities

Accountable for supporting the establishment of downstream vector platform from small scale through intermediate scale (50L) for adeno-associated virus, lentiviral and retroviral vector processes.
Monitoring and reporting on process performance, identifying opportunities, and implementing changes to improve process, product safety, and product quality.
Support process optimization efforts leading to increases in process robustness, cost reduction and improvements in viral yield and purity.
Design and execute experiments independently: accurately record, analyze, and communicate data to senior management and team members.
Frequently communicate with external clients to design experiments and report out on generated data
Maintain open communication via one-on-one and team meetings.
Stay current with relevant technologies and client/industry including identifying new approaches.
Perform and lead single-use system design manifold, selection, implementation, configurations in between Upstream bioreactor and downstream unit operations and control strategies.
Develop appropriate and detailed SOP and BPR for downstream processes including equipment and system use
Responsible for the process transfer from/to clients and to in-house manufacturing team(s).
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