Genezen
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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 QC Analyst II is responsible for performing and supporting a broad range of advanced laboratory functions related to viral vector production and analytics in accordance with cGMP testing guidelines. In this role, the analyst independently executes complex molecular biology assays, aseptic cell culture techniques, and analytical testing with minimal supervision. The position also includes responsibilities for sample and materials management, solution/media preparation, and general lab maintenance, with an increased emphasis on method troubleshooting, data review, and deviation documentation. The QC Analyst II contributes to method qualification, equipment calibration and validation, and supports continuous improvement efforts. This role serves as a technical resource for junior analysts, helping to uphold quality standards and drive operational excellence within the Quality Control team.
ESSENTIAL JOB FUNCTIONS
Independently manage ordering, inventory control, and lifecycle tracking of lab reagents and critical materials to ensure uninterrupted testing operations
Coordinate and oversee sample organization, prioritization, and testing workflows with minimal supervision
Lead sample shipping and receiving processes for internal and outsourced testing, ensuring accurate chain of custody and compliance with applicable regulations
Execute complex hands‑on laboratory procedures related to viral vector production and analytical characterization, including troubleshooting and optimization of methods
Review and ensure accurate, compliant cGMP documentation of laboratory activities; support deviation investigations and CAPA implementation as needed
Perform advanced laboratory and equipment maintenance, and coordinate with internal teams or vendors for calibration, qualification, and repair activities
Serve as a technical trainer and mentor to new staff and junior analysts, supporting their development and adherence to best practices
Ensure compliance with all established policies, SOPs, and cGMP requirements while identifying opportunities for procedural improvements
Collaborate with Quality Assurance and leadership in the development, review, and revision of SOPs, protocols, and related documentation
Responsible for attending client project meetings, tracking related QC activities and ensuring timely execution of project milestones
Actively support and contribute to method qualification, validation, and transfer activities, including drafting protocols, analyzing data, and preparing summary reports
SPECIAL JOB REQUIREMENTS
Adaptability required as work schedule may change based on business needs
Criminal background check required
Other duties as assigned
KNOWLEDGE, SKILLS AND EXPERIENCE EDUCATION / CERTIFICATIONS / LICENSES Associate or BS degree in Biology, Biochemistry, Molecular Biology, or similar field
ON‑THE‑JOB EXPERIENCE 2+ years of relevant industry experience in QC, R&D, product development, or operations
SKILLS / ABILITIES Excellent computer, verbal, and written communication skills
Experience with laboratory techniques including cell culture, cell‑based assays, qPCR, ddPCR, flow cytometry, ELISA, and/or biostatistical analysis
PHYSICAL DEMANDS While performing the duties of this job, the employee is required to meet the following physical demands:
Work Environment
Frequently required to work in a BSL 2 environment with personal protective equipment/aseptic gowning
Regularly required to work around large machinery and typical utilities seen in pharmaceutical facilities
Occasionally exposed to moving mechanical parts; high, precarious places; toxic or caustic chemicals; hazardous waste; and risk of electrical shock
Occasionally exposed to extremely loud noise levels
Spending time on the floor during activity execution (maintenance, construction, commissioning and qualification) is required.
Movement
Frequently required to stand; sit; walk; balance; stoop; kneel; crouch; 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
GENEZEN'S CURES VALUE‑BASED COMPETENCIES
C ommitted to Science: We are committed to scientific 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.
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, vested immediately
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 two locations: one in Fishers, Indiana and the second in Lexington, Massachusetts. Fishers is a suburb of Indianapolis and was named the #1 place to live in the US by Money Magazine in 2017 for its livability, safety and entrepreneurship. Nearby Indianapolis is home to professional and college sports teams, the Indy 500, a growing arts community and the world’s largest children’s museum, making it 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.
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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 QC Analyst II is responsible for performing and supporting a broad range of advanced laboratory functions related to viral vector production and analytics in accordance with cGMP testing guidelines. In this role, the analyst independently executes complex molecular biology assays, aseptic cell culture techniques, and analytical testing with minimal supervision. The position also includes responsibilities for sample and materials management, solution/media preparation, and general lab maintenance, with an increased emphasis on method troubleshooting, data review, and deviation documentation. The QC Analyst II contributes to method qualification, equipment calibration and validation, and supports continuous improvement efforts. This role serves as a technical resource for junior analysts, helping to uphold quality standards and drive operational excellence within the Quality Control team.
ESSENTIAL JOB FUNCTIONS
Independently manage ordering, inventory control, and lifecycle tracking of lab reagents and critical materials to ensure uninterrupted testing operations
Coordinate and oversee sample organization, prioritization, and testing workflows with minimal supervision
Lead sample shipping and receiving processes for internal and outsourced testing, ensuring accurate chain of custody and compliance with applicable regulations
Execute complex hands‑on laboratory procedures related to viral vector production and analytical characterization, including troubleshooting and optimization of methods
Review and ensure accurate, compliant cGMP documentation of laboratory activities; support deviation investigations and CAPA implementation as needed
Perform advanced laboratory and equipment maintenance, and coordinate with internal teams or vendors for calibration, qualification, and repair activities
Serve as a technical trainer and mentor to new staff and junior analysts, supporting their development and adherence to best practices
Ensure compliance with all established policies, SOPs, and cGMP requirements while identifying opportunities for procedural improvements
Collaborate with Quality Assurance and leadership in the development, review, and revision of SOPs, protocols, and related documentation
Responsible for attending client project meetings, tracking related QC activities and ensuring timely execution of project milestones
Actively support and contribute to method qualification, validation, and transfer activities, including drafting protocols, analyzing data, and preparing summary reports
SPECIAL JOB REQUIREMENTS
Adaptability required as work schedule may change based on business needs
Criminal background check required
Other duties as assigned
KNOWLEDGE, SKILLS AND EXPERIENCE EDUCATION / CERTIFICATIONS / LICENSES Associate or BS degree in Biology, Biochemistry, Molecular Biology, or similar field
ON‑THE‑JOB EXPERIENCE 2+ years of relevant industry experience in QC, R&D, product development, or operations
SKILLS / ABILITIES Excellent computer, verbal, and written communication skills
Experience with laboratory techniques including cell culture, cell‑based assays, qPCR, ddPCR, flow cytometry, ELISA, and/or biostatistical analysis
PHYSICAL DEMANDS While performing the duties of this job, the employee is required to meet the following physical demands:
Work Environment
Frequently required to work in a BSL 2 environment with personal protective equipment/aseptic gowning
Regularly required to work around large machinery and typical utilities seen in pharmaceutical facilities
Occasionally exposed to moving mechanical parts; high, precarious places; toxic or caustic chemicals; hazardous waste; and risk of electrical shock
Occasionally exposed to extremely loud noise levels
Spending time on the floor during activity execution (maintenance, construction, commissioning and qualification) is required.
Movement
Frequently required to stand; sit; walk; balance; stoop; kneel; crouch; 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
GENEZEN'S CURES VALUE‑BASED COMPETENCIES
C ommitted to Science: We are committed to scientific 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.
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, vested immediately
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 two locations: one in Fishers, Indiana and the second in Lexington, Massachusetts. Fishers is a suburb of Indianapolis and was named the #1 place to live in the US by Money Magazine in 2017 for its livability, safety and entrepreneurship. Nearby Indianapolis is home to professional and college sports teams, the Indy 500, a growing arts community and the world’s largest children’s museum, making it 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.
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