Clinical Manufacturing Associate

Proclinical; Cranbury Township (NJ); On-site; USD 70,000 - 95,000; Part time

Job summary

Proclinical in Cranbury, NJ is seeking a Clinical Manufacturing Associate to join our team and support the start-up of a cleanroom facility for viral vector therapies.

The role involves hands-on manufacturing, equipment setup, batch documentation, SOP updates, and collaboration with cross-functional teams while maintaining compliance with safety and regulatory requirements.

Qualifications

• 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.

Responsibilities

• Perform hands-on operations to manufacture viral vector therapies following established protocols.
• Set up, operate, and clean equipment while maintaining cleanrooms 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.

Skills

Life Sciences background

Cell culture techniques

Aseptic techniques

Clinical manufacturing experience

Attention to detail

Flexibility/Irregular hours

Communication skills

Problem-solving

Education

Life Sciences / Biotechnology / Chemical Engineering degree

Job description

Clinical Manufacturing Associate - Contract - Cranbury, NJ

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.

Primary Responsibilities:

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.

Skills & Requirements:

• 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.

The Clinical Manufacturing Associate's responsibilities will be:

• Perform hands‑on operations to manufacture viral vector therapies following established protocols.
• Set up, operate, and clean equipment while maintaining cleanrooms 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.