Process Engineer III, Manufacturing Sciences & Technology

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.

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.

The MSAT group plays a critical role in successful manufacturing of clinical and commercial products. The person in this role assists in the transfer of technologies, process validation and cGMP manufacturing of products. This individual will contribute as a core member of various cross‑functional teams, and interacts extensively with other departments within Genezen, including Process Development, Manufacturing, Engineering, Quality, and Regulatory Affairs etc.

• Supports downstream processing unit operations for process implementation, data collection, data analysis, and real‑time troubleshooting (i.e. chromatography, filtration, TFF, buffer generation, drug product filling)
• Assist technology transfer to GMP manufacturing by reviewing process description documents, technology transfer reports, reviewing master batch records, and providing on‑floor support for transfer operations
• Assist manufacturing technical support, including process trouble‑shooting, root‑cause analysis and investigation on process and/or quality discrepancies and deviations during GMP productions, change controls and CAPAs
• Support plan and execution of process/product life cycle management, including continuous process improvement to improve robustness/capacity/productivity, and to increase level of safety and/or compliance
• Experience with statistical analysis of process data (generation and trending control charts, linear regression and multivariate analysis)

• Ability to generate, manage, evaluate, and maintain critical data in a highly organized manner
• Experience with statistical analysis of process data (generation and trending control charts, linear regression and multivariate analysis)
• Criminal background check required
• Other duties as assigned

• BS/MS or degree in Engineering or other related scientific discipline (preferred)

• 3‑6 years (BS) or 1‑4 years (MS) of relevant experience in gene therapy or other biotechnology industry

• Strong communication skills at individual, team, and organizational levels; fluent in English, written and verbal
• Experience in process development/analytical development/MSAT or GMP pharmaceutical manufacturing preferable in the area of viral vaccines or gene therapy
• Experience with technology transfer and GMP manufacturing technical support
• Experience with EMA/FDA regulations, ICH guidelines, GMP and quality systems
• Strong communication skills, including writing and oral presentations
• Ability to generate, manage, evaluate, and maintain critical data in a highly organized manner
• Ability to work in a fast‑paced environment with demonstrated capacity to juggle multiple tasks and demands
• Pro‑active attitude, flexible, professional, independent and a team player
• Experienced project management skills

• Work Environment — Regularly sit for long periods of time
• 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 pounds;
  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,…