Lead Engineer, Manufacturing Sciences & Technology (MSAT)
Genezen
Summary
The 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 description
Job Summary
The 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.
Knowledge, Skills and Experience
Education / Certifications / Licenses: BS/MS/PhD degree in Engineering or other related scientific discipline preferred.
On-the-Job Experience: 5+ years of relevant experience in gene therapy or other biotechnology industry.
Skills / Abilities
- Strong communication skills at individual, team, and organizational levels, including written and oral communication.
- Experience in process development (Upstream must) and sterile GMP manufacturing for cell and gene therapy.
- Experience developing and executing tech transfer from process development into GMP manufacturing.
- Ability to drive process FMEAs and risk assessments.
- Good understanding of upstream processes of viral vectors, cell/gene therapy, or recombinant biologics.
- Proven knowledge and experience of risk-based approaches to process development and validation.
- Demonstrated sufficient knowledge and experience in cell culture and cell & virus banking.
- Ability to cope with many topics in parallel, to cope with strict timelines and to handle pressure.
- 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).
Requirements
- BS/MS/PhD degree in Engineering or other related scientific discipline preferred
- 5+ years of relevant experience in gene therapy or other biotechnology industry
- Strong written and oral communication skills at individual, team, and organizational levels
- Experience in process development (Upstream must) and sterile GMP manufacturing for cell and gene therapy
- Experience developing and executing tech transfer from process development into GMP manufacturing
- Ability to drive process FMEAs and risk assessments
- Good understanding of upstream processes of viral vectors, cell/gene therapy, or recombinant biologics
- Proven knowledge and experience of risk-based approaches to process development and validation
- Demonstrated knowledge and experience in cell culture and cell & virus banking
- Ability to cope with many topics in parallel, strict timelines, and pressure
- Ability to generate, manage, evaluate, and maintain critical data in a highly organized manner
- Experience with statistical analysis of process data (control charts, linear regression, multivariate analysis)
- Criminal background check required
- Experience of working in CDMO space (desired)
- Knowledge of 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)
Benefits
- Paid Vacation Days
- Paid Sick Time
- 10 Observed Holidays
- 2 Floating Holidays
- Volunteer Day
- 401(k) Matching
- Share Appreciation Rights
- Healthcare Plans
- FSA & HSA Programs
- Dental & Vision Care
- Life Insurance
- Personal Accident Insurance
- Voluntary Disability Insurance
- AD&D Insurance
Company overview
Genezen is a leading contract development and manufacturing organization (CDMO) specializing in viral vector manufacturing for gene and cell therapies. Founded in 2014 and headquartered in Lexington, Massachusetts with additional facilities in Indianapolis, Indiana, the company provides comprehensive CDMO services across multiple vector modalities including lentiviral, retroviral, and adeno-associated viral (AAV) vectors. With over a decade of experience in the cell and gene therapy space, Genezen offers end-to-end solutions from process development and analytical testing to cGMP manufacturing and commercial production. The company operates state-of-the-art facilities totaling over 146,000 square feet of cGMP-compliant manufacturing space and holds multiple global regulatory licenses from agencies including the FDA, EMA, Health Canada, and MFDS Korea. Genezen partners with both early-stage biotech companies and established pharmaceutical organizations to accelerate the development and commercialization of potentially life-saving therapies, with a particular focus on oncology, rare diseases, and other complex medical conditions requiring advanced gene and cell therapy approaches.