Lead Engineer, Manufacturing Sciences & Technology (MSAT)
Genezen•Lexington, MA
•$125,000 - $150,000
About The Position
The Lead Engineer, MSAT provides technical leadership for the transfer, validation, and cGMP manufacturing of clinical and commercial gene therapy products in a dynamic CDMO environment. The role leads technical activities across assigned programs, drives process understanding and troubleshooting, evaluates and mitigates technical risks, and supports effective execution as program and client priorities evolve. The position is a key technical partner to Process Development, Manufacturing, Engineering, Validation, Quality, Supply Chain, and external clients, translating process knowledge into robust and reliable manufacturing execution.
Requirements
- 5+ years of relevant experience in gene therapy or another biotechnology industry.
- Experience in process development, with upstream experience required, and sterile GMP manufacturing for cell and gene therapy.
- Experience developing and executing technology transfer from process development into GMP manufacturing.
- Ability to drive process FMEAs and risk assessments.
- Good understanding of upstream processes for viral vectors, cell and gene therapy, or recombinant biologics.
- Knowledge and experience using risk-based approaches to process development and validation.
- Sufficient knowledge and experience in cell culture and cell and virus banking.
- Ability to manage multiple topics in parallel, work to strict timelines, and handle pressure.
- Strong written and oral communication skills at individual, team, and organizational levels.
- Ability to generate, manage, evaluate, and maintain critical data in a highly organized manner.
- Experience with statistical analysis of process data, including generating and trending control charts, linear regression, and multivariate analysis.
- Criminal background check required.
Nice To Haves
- BS, MS, or PhD degree in Engineering or another related scientific discipline.
- Experience working in a CDMO environment.
- Knowledge of current pharmaceutical, regulatory, and technology trends.
- Knowledge of data management tools and statistical process controls.
- Understanding of downstream processes for viral vectors, cell and gene therapy, or recombinant biologics.
Responsibilities
- Lead technology transfer to GMP manufacturing, including drafting and reviewing process description documents and technology transfer reports, reviewing master batch records and protocols, and providing on-floor support for transfer operations.
- Provide manufacturing technical support, including process troubleshooting, root cause analysis, and investigation of process or quality discrepancies and deviations during GMP production, change controls, and CAPAs.
- Support planning and execution of process and product lifecycle management, including continuous upstream process improvement to improve robustness, capacity, productivity, and compliance.
- Collaborate cross-functionally with Process Development, Manufacturing, QC, QA, Engineering, Validation, and Supply Chain as needed.
- Lead process validation campaigns to develop a thorough understanding of operating and performance parameters.
- Generate, manage, evaluate, and maintain critical data in a highly organized manner.
- Perform other duties as assigned.
Benefits
- Paid vacation days, with amount based on tenure.
- Paid sick time.
- 10 observed holidays, 2 floating holidays, and 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 and vision care.
- Employer-paid basic term life and personal accident insurance.
- Voluntary disability, universal life, and personal accident insurance.
- Accidental Death & Dismemberment (AD&D) insurance.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
