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.

ESSENTIAL JOB FUNCTIONS

• Be accountable for establishing the platform from small scale through intermediate scale (50L) lentiviral and retroviral vector processes.
• Responsible for monitoring and reporting on process performance, identifying opportunities, and implementing changes to improve process, product safety, and product quality.
• Develop and support process optimization efforts to increase process robustness, reduce costs, and improve viral yield and purity.
• Design and execute experiments independently: accurately record, analyze, and communicate data to senior management and team members.
• Maintain open communication via one-on-one and team meetings.
• Stay current with relevant technologies and need to be adept at 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 proper SOP/ SSP for Upstream processes.
• Responsible for the process transfer from or to clients and to in-house manufacturing plant.
• Maintain external technical relationships and collaborate with equipment and material suppliers.
• Serve as process SME for regulatory and client audits.
• 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

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 or balance; and stoop, kneel, crouch, or crawl

Lifting

• Frequently lift and/or move up to 10 pound
• Occasionally lift and/or move up to 25 pounds

Vision

• Frequently utilize close vision and the ability to adjust focus

Communication

• Frequently required to communicate by talking, hearing, using telephone and e-mail