The Cell Therapy Bioengineering Associate will be responsible for performing routine processes for the manufacture of human blood derived cell therapies in a controlled, cGMP cleanroom environment of a multi-product facility.
The incumbent will be responsible for operating equipment for autologous and allogeneic cell therapy processes and performing lab support activities while maintaining compliance to cGMP standards.
The successful candidate will play a key role in establishing best practices that will become standards of procedure for the cell therapy organization.
We are looking for an individual that has experience working within a team, is hard-working, self-motivated, results-driven, and solution-oriented.
This position requires multi-tasking, interdepartmental coordination, and excellent peer-to-peer communication skills.
This position has the potential to evolve into a higher-level.
- Work cross-functionally in a hands-on capacity utilizing aseptic technique to perform cell culture processes through cell culture, harvest, and cryopreservation and lab support activities within a cleanroom environment.
- Ensure work is completed in compliance with controlled documentation (SOPs, batch records, forms, etc.) and all applicable guidelines, safety policies and procedures are followed.
- Become fully trained and qualified in all aspects of assigned processes.
- Maintain manufacturing facility in a cGMP status and ensure a continued state of inspection readiness.
- Adhere to the schedule ensuring manufacturing logistics are maintained on time.
- Have a basic – advanced technical knowledge of cell therapy processes.
- Record process data and information in a clear/concise format according to proper GDPs.
- Ability to adapt to and/or proven efficiency in working with basic lab equipment, specific Cell Therapy process equipment, and manufacturing logistics systems.
- Author and revise documents for equipment and processes within assigned timeline.
- Assist in validation activities related to the qualification of the inaugural manufacturing facility suites and process equipment.
- Perform tech transfer activities related to new product introduction to the manufacturing facility as assigned.
- Assist in the resolution of manufacturing deviations.
- When applicable, troubleshoot process and equipment problems.
- Demonstrate a positive attitude within the team and proven ability to complete assignments on time.
- Bachelor’s degree in biological science(s) field or related engineering is preferred but not required.
- A minimum of 0-5 years of experience in cGMP biological manufacturing. Cell therapy manufacturing is highly preferred.
- An understanding of cell culture, cryopreservation, and aseptic processing/technique.
- Efficient written and verbal communication skills, with excellent teamwork aptitudes.
- Familiarity of cGMP and FDA regulations.
- Basic mathematical skills
- Technical writing capabilities, from basic to advanced.
- Experience with MS Office applications.
- Ability to carry up to 55 pounds.
- Ability to stand for long periods of time while wearing PPE.
- Ability to work weekends/off-shift hours, when applicable. This position has the possibility to evolve into a second shift or off-shift position.