Jobs at Genezen

You will implement Genezen's business development strategy by identifying and engaging new CDMO clients, coordinating visits and proposals, negotiating agreements, and maintaining client relationships. This role requires expertise in viral vector development and manufacturing, and the ability to drive sales objectives in a fast-growing gene therapy company.

You will lead and oversee GMP manufacturing operations on the 2nd shift, ensuring safety, aseptic practices, and compliance while training team members and driving continuous improvement.

You will provide maintenance, calibration, and technical support for manufacturing and facility equipment, ensuring compliance with standards and supporting gene therapy production. You'll plan and perform calibrations, coordinate external vendors, and maintain records in a CMMS.

You will manage computer system validation projects, develop test protocols, execute qualifications, and ensure compliance with cGMP regulations in a fast-growing gene therapy company.

Lead and supervise upstream, downstream, and cell/virus banking teams in a GMP manufacturing facility. Oversee daily operations, ensure compliance with cGMPs, and drive continuous improvement to support gene therapy production.

You will perform routine and non-routine manufacturing operations in Cell Culture, Purification, and Solution Equipment Prep areas for the production of clinical and commercial products. You will operate production equipment following SOPs and batch records, document activities, and support equipment cleaning and qualifications. This role contributes to the growing field of gene therapy by ensuring compliant GMP production.

You will lead the Quality Control Technical Services Data Integrity function, ensuring QC laboratory systems, instruments, software, and data workflows meet regulatory expectations for data integrity and GxP compliance. You'll partner with QC operations, Validation, IT, and system owners to design and maintain compliant systems.

You will govern the stability program for client programs, ensure compliance with quality agreements and regulatory expectations, and manage the stability master planner while supervising a team and owning quality documentation.

You will act as the primary contact between clients and internal teams to manage gene therapy viral vector projects from process development through GMP manufacturing. You'll track progress, resolve issues, and ensure on-time delivery while building strong client relationships.

You'll provide **quality oversight** for **gene therapy manufacturing** operations, ensuring GMP and regulatory compliance. Your core impact is driving quality events to closure and improving processes. This role offers a chance to **shape quality systems** at a fast-growing CDMO.

You will provide automation support and troubleshooting for Genezen's operational groups, lead automation projects to improve equipment and process controls, and develop test scripts and procedures. Your work directly supports gene therapy manufacturing for clinical trials.

You'll lead **upstream viral vector development** for gene therapy, managing a team of scientists to **advance platform processes**. You'll drive **technology transfer and GMP support**, collaborating across departments and with clients.

You'll perform cGMP manufacturing operations including cell culture and purification for gene therapy clinical trials. Your work directly supports the production of life-saving treatments. This role offers growth in a fast-paced biotech environment.

You'll lead transfer and validation of analytical methods for **gene therapy products** in a fast-paced CDMO environment. Your work will directly support **cGMP production** and client projects, ensuring regulatory compliance. This role offers the chance to shape Quality Control Technical Services at a growing company.

You'll **lead analytical method development and validation** for **gene therapy viral vectors** under cGMP standards. Your work directly impacts the path to new cures by ensuring robust QC assays. You'll collaborate cross-functionally in a fast-growing company.

You'll support gene therapy manufacturing operations, providing technical expertise for equipment, processes, and validations. You will troubleshoot issues and lead projects to improve **single-use manufacturing systems**. This role offers the chance to contribute directly to **life-saving therapeutics** in a **fast-growing biotech environment**.

You'll lead **all QC laboratory activities** for a fast-growing gene therapy company, ensuring **timely testing** of clinical-grade biopharmaceuticals and acting as the **aseptic subject matter expert**.

You'll join Genezen's QC Microbiology team to perform environmental monitoring in pharmaceutical cleanrooms. Your work ensures cGMP compliance and supports gene therapy production. This contract-to-hire role offers hands-on experience in a fast-growing CDMO.

You'll be responsible for assisting the Validation manager in completing equipment and utilities qualifications for gene therapy production. Your core impact involves executing protocols, performing calibrations, and generating documentation in a cGMP environment. This temp role is onsite 5 days per week in Lexington, MA.