Process Engineer III, Manufacturing Sciences & Technology
Genezen
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Benefits offered by this job
Job summary
Genezen is seeking an MSAT professional to join the team in Lexington, MA, contributing to technology transfer, process validation, and cGMP manufacturing for gene therapy products. You will work cross-functionally with Process Development, Manufacturing, Engineering, Quality, and Regulatory Affairs to drive successful transfer and scale-up initiatives.
The role emphasizes data-driven process optimization, analytical support, and collaboration across departments to ensure product quality and
Qualifications
- BS/MS in Engineering or related scientific discipline preferred.
- 3-6 years (BS) or 1-4 years (MS) of relevant experience in gene therapy or biotechnology.
- Fluent in English, written and verbal.
Responsibilities
- Supports downstream processing unit operations for process implementation, data collection, analysis, and real-time troubleshooting (chromatography, filtration, TFF, buffer generation).
- Assist technology transfer to GMP manufacturing by reviewing process docs, transfer reports, master batch records, and provide on-floor support.
- Assist manufacturing technical support, including troubleshooting, root-cause analysis and investigation on process/quality discrepancies and deviations during GMP productions, change controls and CAPAs.
- Support life cycle management with continuous process improvement to improve robustness/capacity/productivity and safety/compliance.
- Experience with statistical analysis of process data (generation and trending control charts, linear regression and multivariate analysis).
Skills
Education
Job description
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.
Manypeople 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 Affair 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
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BS/MS or degree in Engineering or other related scientific discipline preferred
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3-6 (BS) or 1-4 (MS) years of relevant experience in gene therapy or other biotechnology industry
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Strong communication skills at individual, team, and organizational levels; fluent in English, written and verbal
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Experience in process development/analytical development/MSAT or GMP pharmaceutical manufacturing preferable in the area of viral vaccines or gene therapy
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Experience with technology transfer and GMP manufacturing technical support is preferred
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Experience with EMA/FDA regulations, ICH guidelines, GMP and quality systems
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Strong communication skills, including writing and oral presentations
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Ability to generate, manage, evaluate, and maintain critical data in a highly organized manner
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Ability to work in a fast paced environment with demonstrated capacity to juggle multiple tasks and demands
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Pro-active attitude, flexible, professional, independent and a team player
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Experienced project management skills
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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
The annual salary range for this position is $105,000-$130,000.
C ommitted to Science
We are committed toscientific excellence, staying current with industry developments, making data-driven decisions, and pursuing innovation to advance healthcare.
U rgency in action for the patients
We operate with urgency and a commitment to delivering timely treatments to patients by accelerating our partners’ programs.
R esilience & Grit in operations
We are committed to overcoming challenges, learning from failures, and persistently striving for success.
E xecute with Excellence & Integrity
We are dedicated to delivering quality results and upholding ethical principals.
S olutions driven for our partners
We are committed to being a proactive, collaborative, creative and open-minded partner.
- 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
- 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.
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