Clinical Manufacturing Associate

Step into the future of medicine-manufacture viral vector therapies that power the next generation of gene treatments.

Proclinical is seeking a Clinical Manufacturing Associate to join a dynamic team in NJ, US. If you are passionate about science and gene therapy and thrive in a fast-paced environment, this role offers an exciting opportunity to make a meaningful impact.

The successful candidate will contribute to the start-up of a cleanroom facility and support the cGMP manufacturing of viral vector therapies for clinical trials. This position involves hands‑on process operations, equipment setup and maintenance, inventory management, and technical documentation.

• Academic background in Life Sciences, Biotechnology, Chemical Engineering, or a related field.
• Familiarity with mammalian/microbial cell culture techniques, filtration, purification, and aseptic techniques.
• Experience in clinical manufacturing, with the ability to execute production based on established procedures.
• Strong attention to detail and a commitment to completing tasks accurately and efficiently.
• Ability to work flexible hours, including early mornings, late evenings, nights, or weekends as needed.
• Effective communication and collaboration skills to work with diverse teams and elevate issues when necessary.
• Problem‑solving mindset with the ability to assess options and take proactive action.

• Perform hands‑on operations to manufacture viral vector therapies following established protocols.
• Set up, operate, and clean equipment while maintaining clean rooms and equipment in an inspection‑ready state.
• Monitor and troubleshoot processes and equipment to ensure smooth operations.
• Receive, process, and store materials and supplies in coordination with Materials Management‑Warehouse personnel.
• Author and update Standard Operating Procedures (SOPs) and other technical documents.
• Complete batch documentation, including Batch Records, Forms, Logbooks, Sample Requests, and Test Results.
• Proactively identify and resolve potential issues with equipment, supplies, or processes.
• Collaborate with cross‑functional teams and stakeholders to address challenges and implement improvements.
• Follow all safety, regulatory, and compliance requirements.