About AIVITA Biomedical
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.
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. 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.
What You’ll Do
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.
Who You Are
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.
