Process Engineer III, Manufacturing Sciences & Technology

Process Engineer III, Manufacturing Sciences & Technology

Lexington, MA

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.

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.

• 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 troubleshooting, 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 and drug screening required
• Other duties as assigned

In addition to special job requirements, the candidate should possess the following skills and experience:

• 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 is preferred
• 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

BS/MS or degree in Engineering or other related scientific discipline preferred.

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

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

• 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, hearing, using telephone and e‑mail

The annual salary range for this position is $105,000-$130,000.

Genezen is an Equal Opportunity Employer.

Genezen participates in EVerify.

Genezen is interested in every qualified candidate who is eligible to work in the United States; however, we are not able to sponsor visas.