The QC Analyst III will conduct routine and non-routine QC testing according to SOPs, focusing on analytical and bioassay testing. Responsibilities include in-process testing, lot release testing, stability testing, managing Quality Systems, and supporting audits. The role requires collaboration and communication across departments to ensure compliance with cGMP guidelines.

The Quality Operations Associate is responsible for overseeing quality assurance and quality systems, ensuring compliance with GMP and regulatory requirements. Duties include reviewing documentation, providing training, managing Quality Events, and facilitating inspections and audits, while collaborating cross-functionally to ensure product quality.

The Director of Quality Assurance leads the Quality Operations team, ensuring compliance with GMP standards, managing regulatory inspections, and overseeing raw material inspection and release. Responsibilities include improving quality systems, mentoring QA teams, and collaborating with cross-functional teams to integrate quality in all processes, ensuring audit readiness and continuous improvement in the organization.

The Process Engineer is responsible for supporting engineering and technical disciplines related to gene therapy processes. Key responsibilities include project management, compliance monitoring, quality control, and implementing safety management systems. This role emphasizes workflow optimization and the enhancement of facilities, ensuring adherence to FDA standards while driving continuous improvement initiatives.

The Program Manager will oversee client programs related to gene therapy production, ensuring project delivery through effective communication, tracking, and coordination with team members and stakeholders. They are responsible for managing timelines, addressing risks, and maintaining client satisfaction in a fast-paced environment.

The Program Manager oversees client programs in the gene therapy sector, focusing on process development and GMP manufacturing of viral vectors. Responsibilities include managing project schedules, facilitating communication, ensuring compliance with requirements, and building client relationships while supporting financial goals.

The Process Engineer II/III/Senior will provide operational and technical support across Genezen’s manufacturing facility, developing solutions to complex problems, supporting the design and implementation of manufacturing systems, and driving improvement projects.

The individual will establish processes in Downstream Process Development, ensuring scalable platform production of viral vectors. Responsibilities include process optimization, monitoring performance, maintaining compliance with regulations, and collaborating with stakeholders. The role requires leading design for single-use systems and serving as a subject matter expert for audits.