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.
JOB SUMMARYThe Lead Engineer, MSAT provides technical leadership for the transfer, validation, and cGMP manufacturing of clinical and commercial gene therapy products within a dynamic CDMO environment. The role leads technical activities across assigned programs, drives process understanding and troubleshooting, evaluates and mitigates technical risks, and ensures effective execution as program and client priorities evolve. This individual serves as a key technical partner to Process Development, Manufacturing, Engineering, Validation, Quality, Supply Chain, and external clients, helping translate process knowledge into robust and reliable manufacturing execution.
JOB RESPONSIBILITIES- Lead technology transfer to GMP manufacturing by drafting/reviewing process description documents and technology transfer reports, reviewing master batch records, protocols, and providing on-floor support for transfer operations.
- Assist with manufacturing technical support, including process troubleshooting, root cause analysis, and investigation of process and/or quality discrepancies and deviations during GMP production, change controls, and CAPAs.
- Support the planning and execution of process/product lifecycle management, including continuous upstream process improvement to improve process robustness, capacity, and productivity and/or compliance
- Cross functional collaboration with Process Development, Manufacturing, QC, QA, Engineering, Validation and Supply Chain, as needed.
- Lead process validation campaign to develop a thorough understanding of operating and performance parameters.
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 EXPERIENCEEDUCATION / CERTIFICATIONS / LICENSESEssential/DesiredBS/MS/PhD degree in Engineering or other related scientific discipline preferred
Essential
ON-THE-JOB EXPERIENCE5+ years of relevant experience in gene therapy or other biotechnology industry.
Essential
SKILLS / ABILITIESStrong communication skills at individual, team, and organizational levels, including written and oral communication
Essential
Experience in process development (Upstream must) and sterile GMP manufacturing for cell and gene therapy
Essential
Experience developing and executing tech transfer from process development into GMP manufacturing.
Essential
Ability to drive process FMEAs and risk assessments
Essential
Good understanding of upstream processes of viral vectors, cell/gene therapy, or recombinant biologics.
Essential
Proven knowledge and experience of risk-based approaches to process development and validation.
Essential
Demonstrated sufficient knowledge and experience in cell culture and cell & virus banking.
Essential
Ability to cope with many topics in parallel, to cope with strict timelines and to handle pressure.
Essential
Ability to generate, manage, evaluate, and maintain critical data in a highly organized manner.
Essential
Experience of working in CDMO space.
Desired
Knowledge of the current pharmaceutical, regulatory, and technology trends.
Desired
Knowledge of data management tools and statistical process controls.
Desired
Understanding of downstream processes of viral vectors, cell/gene therapy, or recombinant biologics.
Desired
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 $125,000-$150,000.
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 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.
