Sr. Engineer, 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 Global MSAT group plays a critical role in successful manufacturing of clinical and commercial products.  The person in this role assists MSAT team in the transfer of technologies, process validation and cGMP manufacturing of Genezen’s gene therapy products. 

JOB RESPONSIBILITIES: 

•  Lead all aspects of process technology transfer from early and late-stage process development for clinical and commercial manufacturing.
• Provide technical support to manufacturing and write product impact assessments to support deviations.
• Provide input on scope of work proposals to ensure clients’ goals are met.
• Cross functionally collaboration with Process Development, Manufacturing, QC, QA, Engineering, Regulatory Affairs, Validation and Supply Chain as needed
• Ensure successful manufacturing production runs by assessing risk, setting preventative measures in place, investigating, and troubleshooting equipment and process issues.
• Runs client facing meetings regarding technical topics and scope of work progress
• Ability to provide impact assessments and aid in root-cause analysis for critical deviations and determine CAPAs for manufacturing.
• Author technical documentation: Protocols, and reports.
• Reviews executable documents: Batch records, SOPs,
• Assist process validation studies to develop a thorough understanding of operating and performance parameters.
• Support data monitoring and trending analysis using statistical process control charts. 

SPECIAL JOB REQUIREMENTS

•  Ability to generate, manage, evaluate, and maintain critical data in a highly organized manner
• Experience with customer facing discussions
• Experience with statistical analysis of process data (generation and trending control charts, linear regression and multivariate analysis)  

KNOWLEDGE, SKILLS AND EXPERIENCE

EDUCATION / CERTIFICATIONS / LICENSES

Essential/Desired

Bachelor's Degree in Engineering or other related scientific discipline.

Essential

Master's Degree in Engineering or other related scientific discipline.

Desired

ON-THE-JOB EXPERIENCE

 

6+ (BS) or 4+ (MS) or 0-2 (PhD) years of relevant experience in gene therapy or other biotechnology industry.

Essential

SKILLS / ABILITIES

 

Experience in process development/analytical development/MSAT or GMP pharmaceutical manufacturing.

Essential

Good understanding of upstream and downstream processes of viral vectors, cell therapy, or recombinant biologics.

Essential

Ability to present to and interact with clients on behalf of the MSAT team

Essential

Experience developing and executing tech transfer into GMP manufacturing.

Essential

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

Essential

Experience with statistical analysis of process data (generation and trending control charts, linear regression and multivariate analysis)

Essential

Strong communication skills at individual