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Job Title: Manufacturing Associate - Cell Therapy
Company: AIVITA Biomedical, Inc.
Location: Irvine, CA
(Onsite -Southern California candidates within a reasonable commute only, due to on‑site, time‑sensitive manufacturing work)
Employment Type: Full-time, Exempt

AIVITA Biomedical is a fast-growing biotechnology company advancing personalized vaccines for the prevention of infectious disease and treatment of cancer. Our autologous cell therapy platform, built on cutting-edge immunology and stem cell science, is driving multiple clinical programs and innovative vaccine technologies. We operate in a dynamic, collaborative environment where every team member directly contributes to product quality, patient safety, and our mission to transform lives through science.

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. The role offers broad exposure to clinical manufacturing, quality, and cross-functional collaboration in a small-company setting where the work directly supports patients and key business milestones.

This role is on-site in Irvine, CA. Due to the on-site and patient-driven nature of the work, we are prioritizing candidates who currently reside in Southern California and are within a reasonable commuting distance (~25 miles of Irvine).

Clinical Manufacturing

• 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.

Troubleshooting and Process Support

• Participate in routine troubleshooting during manufacturing runs by documenting findings, contributing to root-cause discussions, and helping test practical fixes.
• Assist with process improvements and development protocols that enhance robustness, efficiency, or scalability of manufacturing operations.

Teamwork and Flexibility

• Collaborate closely with Manufacturing, R&D, QA, QC, and other functions to meet clinical and operational timelines.
• Work primarily standard weekday hours, with flexibility for occasional early mornings, evenings, or weekends driven by patient specimen receipts and manufacturing demand.

Required 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.

Preferred Qualifications

• Experience handling human clinical specimens such as tumor tissue, blood-derived products or materials.
• Background in clinical-stage cell therapy, regenerative medicine, or other human cell-based product manufacturing.
• Exposure to process troubleshooting in manufacturing or cell culture environments.
• Experience assisting with SOP or batch record updates, or informal training of peers on laboratory procedures.
• Exposure to flow cytometry or similar cell-based analytical methods is a plus, but not a main focus of this role.

What Success Looks Like

• Ramps quickly to independent execution of assigned manufacturing tasks with consistently high-quality results.
• Produces complete, accurate documentation with minimal corrections and supports an inspection-ready environment.
• Recognizes and communicates issues early, contributing to effective troubleshooting and process improvements.
• Supports the team in meeting clinical production timelines, including occasional off-hour work when required by patient schedules.

Who This Role Is Ideal For

This role is ideal for candidates who enjoy hands-on lab work, value quality and documentation, and want to build a career in cell therapy manufacturing in a growing company. It is not a senior or people-management position; candidates seeking an immediate lead or supervisory title may find it misaligned with expectations.

This position is fully on‑site in Irvine, CA. At this time, we are only considering applicants who currently reside in Southern California and can commute reliably to our Irvine facility.