Scientist II​/III, Downstream Process 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

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.

JOB 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.

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 or MS in biological engineering

Desired

ON-THE-JOB EXPERIENCE

2-8+ years of relevant industry experience

Essential

Solid foundation in the fundamentals of biochemical engineering, virology and cell biology

Essential

Experience with industry standard chromatography and filtration methods

Essential

Ability to hypothesize and drive key experiments for internal and external programs

Essential

Entrepreneurial experience dealing with customers in product development

Desired

Pharmaceutical industry experience in technical support of cGMP manufacturing and/or process development, including experience with Contract Development and Manufacturing Organizations

Desired

Experience with cell culture technologies, molecular biology, upstream processing, and aseptic processing

Desired

Understanding of analytical assays used in the characterization of biologics

Desired

SKILLS / ABILITIES

Working knowledge of AKTAs and UNICORN software

Essential

Familiar with tangential flow filtration skids

Desired

Ability to interface successfully with multi-disciplined teams.

Desired

Extremely detail-oriented with strong technical skills & mechanically inclined/knowledge of hand tools

Desired

PHYSICAL DEMANDS

While performing the duties of this job, the employee is required to meet the following physical demands:

Work Environment

• Frequently required to work in a BSL 2 environment with personal protective equipment/aseptic gowning.
• Regularly required to work around large machinery and typical utilities seen in pharmaceutical facilities.
• Occasionally exposed to moving mechanical parts; high, precarious places; toxic or caustic chemicals; hazardous waste; and risk of electrical shock.
• Occasionally exposed to extremely loud noise levels
• Spending time on the floor during activity execution (maintenance, construction, commissioning and qualification) is required.

Movement

• Frequently required to stand; sit; use hands to finger, handle, or feel; reach with hands and arms.
• Occasionally required to walk; climb…