Manufacturing Associate - Cell Therapy

About the role

The Manufacturing Department is hiring a mid-level Manufacturing Associate to support clinical cell therapy programs in a fast-paced biotech environment. This is a hands-on, execution-focused role for someone with at least 2 years of relevant experience who wants to deepen cGMP manufacturing capability and grow with the company over time. You will help manufacture patient-specific and related cell-based products, working with primary and established human cell cultures in a cGMP setting, and contribute to selected process improvements and development activities as programs evolve.

Responsibilities

• Execute cGMP manufacturing activities for cell therapy products according to approved SOPs and production schedules.
• Perform aseptic cell culture and associated processing steps on primary human cell cultures and patient biomaterial in a regulated laboratory environment.
• Handle patient-derived materials from receipt through cell isolation, expansion, final product manufacturing, QC submissions, and preparation for shipment or release.
• Prepare media, reagents, QC submission samples, and support cryo-inventory and material management. Documentation and Quality
• Complete batch records and other controlled documentation accurately, legibly, and in real time following good documentation practices.
• Monitor processes for deviations or atypical observations and promptly escalate issues through appropriate channels.
• Support sample submissions to QC and help maintain audit-ready documentation and work areas.
• Troubleshoot and process support
• Participate in routine troubleshooting during manufacturing runs by documenting findings, contributing to root-cause discussions, and helping test practical fixes.
• Aid in process improvements and development protocols that enhance robustness, efficiency, or scalability of manufacturing operations.

Requirements

• Bachelor’s degree in biology, biochemistry, biotechnology, biomedical science, or a closely related life-science field, or equivalent practical experience.
• Minimum of 2 years of relevant hands-on experience in cell culture, biologics manufacturing, cell therapy manufacturing, or a comparable biotech laboratory environment.
• Proven aseptic technique with mammalian cell culture; experience with primary human cells is strongly preferred.
• Experience working within cGMP or similarly regulated environments, including completing batch records or other controlled documentation.
• Strong attention to detail, organization, and follow-through.
• Demonstrated ability to learn new protocols quickly and execute them consistently after training.
• Clear, professional written and verbal communication skills.
• Willingness to work an on-site role with occasional schedule flexibility based on patient and program needs.

Qualifications

• Bachelor’s degree in biology, biochemistry, biotechnology, biomedical science, or a closely related life-science field, or equivalent practical experience.
• Minimum of 2 years of relevant hands-on experience in cell culture, biologics manufacturing, cell therapy manufacturing, or a comparable biotech laboratory environment.
• Proven aseptic technique with mammalian cell culture; experience with primary human cells is strongly preferred.
• Experience working within cGMP or similarly regulated environments, including completing batch records or other controlled documentation.
• Strong attention to detail, organization, and follow-through.
• Demonstrated ability to learn new protocols quickly and execute them consistently after training.
• Clear, professional written and verbal communication skills.
• Willingness to work an on-site role with occasional schedule flexibility based on patient and program needs.