Recently postedManufacturing

Lead Engineer, Manufacturing Sciences & Technology (MSAT)

GenezenLexington🇺🇸United States

Quick overview

Salary$125k - $150k/yr

SeniorityMid Senior

Work modeHybrid

LocationLexington, United States

LinearClinical TrialsComplianceProcess ImprovementRoot Cause AnalysisTechnical Support

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.

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 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 EXPERIENCE

EDUCATION / CERTIFICATIONS / LICENSES	Essential/Desired
BS/MS/PhD degree in Engineering or other related scientific discipline preferred	Essential
ON-THE-JOB EXPERIENCE
5+ years of relevant experience in gene therapy or other biotechnology industry.	Essential
SKILLS / ABILITIES
Strong 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 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.