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.

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

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 Affair etc..

JOB RESPONSIBILITIES

• 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)

SPECIAL JOB REQUIREMENTS

• 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

KNOWLEDGE, SKILLS AND EXPERIENCE

EDUCATION / CERTIFICATIONS / LICENSES

Essential/Desired

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

Essential/Desired

ON-THE-JOB EXPERIENCE

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

Essential

SKILLS / ABILITIES

Strong communication skills at individual, team, and organizational levels; fluent in English, written and verbal

Essential

Experience in process development/analytical development/MSAT or GMP pharmaceutical manufacturing preferable in the area of viral vaccines or gene therapy

Essential

Experience with technology transfer and GMP manufacturing technical support is preferred

Essential

Experience with EMA/FDA regulations, ICH guidelines, GMP and quality systems

Essential

Strong communication skills, including writing and oral presentations

Essential

Ability to generate, manage, evaluate, and maintain critical data in a highly organized manner

Essential

Ability to work in a fast paced environment with demonstrated capacity to juggle multiple tasks and demands

Essential

Pro-active attitude, flexible, professional, independent and a team player

Essential

Experienced project management skills

Essential

PHYSICAL DEMANDS

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

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,…