Asks for

The ad says“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)”
The ad says“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)”
The ad says“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)”
The ad says“Experience with EMA/FDA regulations, ICH guidelines, GMP and quality systems”
The ad says“Strong communication skills at individual, team, and organizational levels; fluent in English, written and verbal”
The ad says“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)”
The ad says“Experience with EMA/FDA regulations, ICH guidelines, GMP and quality systems”
The ad says“Experience with EMA/FDA regulations, ICH guidelines, GMP and quality systems”
The ad says“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”
The ad says“Experienced project management skills”
The ad says“Experience with EMA/FDA regulations, ICH guidelines, GMP and quality systems”
The ad says“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”
The ad says“Experience with statistical analysis of process data (generation and trending control charts, linear regression and multivariate analysis)”
The ad says“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)”

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
5-8 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, 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

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

GENEZEN'S CURES VALUE-BASED COMPETENCIES

Committed to Science
We are committed to scientific excellence, staying current with industry developments, making data-driven decisions, and pursuing innovation to advance healthcare.

Urgency in action for the patients
We operate with urgency and a commitment to delivering timely treatments to patients by accelerating our partners' programs.

Resilience & Grit in operations
We are committed to overcoming challenges, learning from failures, and persistently striving for success.

Execute with Excellence & Integrity
We are dedicated to delivering quality results and upholding ethical principals.

Solutions driven for our partners
We are committed to being a proactive, collaborative, creative and open-minded partner.

GENEZEN'S BENEFITS

Paid vacation days, amount based on tenure
Paid sick time
10 observed holidays + 2 floating holiday + 1 volunteer day
401(k) plan with company match up to 6% of salary
Share Appreciation Rights
Choice of several healthcare plans
FSA and HSA programs
Dental & vision care
Employer-paid basic term life/personal accident insurance
Voluntary disability, universal life/personal accident insurance
Accidental Death & Dismemberment (AD&D) Insurance

ADDITIONAL DETAILS

Nothing in the job description for this role restricts management’s right to assign or reassign duties and responsibilities to this job at any time.
This position requires a criminal background check.
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.

Genezen has operates two locations: one in Fishers, Indiana and the second in Lexington, Massachusetts.

Fishers is a suburb of Indianapolis. Fishers was named the #1 place to live in the US by Money Magazine in 2017 for its livability, safety and entrepreneurship. Fishers is one of the fastest growing communities in Indiana and is dedicated to supporting a high quality of life for all its residents. Nearby Indianapolis is home to professional and college sports teams, the Indy 500, a growing art community and the world’s largest children’s museum--to name just a few reasons why this area is a great place to live.

Lexington, Massachusetts, located just northwest of Boston, is renowned as a historic suburb with a rich cultural heritage. It boasts picturesque New England charm, tree-lined streets, and a vibrant community. Known for its pivotal role in the American Revolution, Lexington offers visitors and residents alike a blend of historical landmarks, modern amenities, and a strong sense of community pride.