JOB SUMMARY

Responsible for supporting projects from advanced laboratory techniques related to viral vector production and analytics to routine performance of upstream and downstream manufacturing operations including aseptic cell culture technique, preparing solutions and media, molecular biology techniques, chromatography, TFF and general cleanroom sanitization/area maintenance. The position requires working independently, but also under the supervision of experienced personnel.

ESSENTIAL JOB FUNCTIONS

• Execute hands on project work from process development through manufacturing related to viral vector production including upstream and downstream GMP manufacturing tasks under the guidelines of established procedures and batch records
• Perform hands on laboratory procedures related to viral vector production and characterization
• Perform daily operations in the scale-up, production, harvest, clarification, purification, and fill/finish of retro, lenti, and AAV viral vectors.
• Execute production activities including cell thawing, cell passaging, bioreactor inoculation, clarification filtration, chromatography, tangential flow filtration, sterile filtration and filling of viral products following GMP guidance and according to applicable batch records.
• Maintain appropriate GDP documentation of processing activities
• Perform routine lab maintenance and maintenance of laboratory equipment
• Assist in the development of general and technical SOPs and with the creation of client specific procedures and batch records
• Maintain manufacturing material supply, primarily ensuring manufacturing spaces are adequately stocked and prepared
• Assist in the maintenance of laboratory equipment and laboratory support operations
• 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 lab and manufacturing equipment
• Assist in troubleshooting of upstream and downstream manufacturing issues
• Cross train new staff members and fellow employees in designated processes
• Comply with all established policies and SOPs
• Perform safety inspections and maintain a safe working environment
• Participate actively in continuous improvement activities and SOP revisions in coordination with management and Quality Assurance
• Perform area sanitization and collect/dispose of waste per established procedures
• Help collect process data for metrics/trending
• Use and maintenance of cGMP equipment

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

Movement

• Frequently required to stand; sit; walk; balance; stoop; kneel; crouch; 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 25 pounds
• Occasionally lift and/or move up to 50 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