Cell Therapy Lead Bioengineer

King of Prussia

Summary

The Cell Therapy Lead Bioengineer 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 internal standards for onboarding and training of new cell therapy team members while 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, continuous improvement mindset, self-motivated, results driven and problem 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 management role.

Responsibilities

·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 as an established lab owner.

·Adhere to the schedule ensuring manufacturing logistics are maintained on time.

·Highly established technical knowledge of cell therapy processes.

·Record process data and information in a clear/concise format according to proper GDPs.

·Advanced efficiency in working with basic lab equipment, specific Cell Therapy process equipment, and manufacturing logistics systems.

·Author/revise and review documents for facility/equipment and processes within assigned timeline and a high level of competency.

·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 as an established lab owner.

·Adhere to the schedule ensuring manufacturing logistics are maintained on time.

·Highly established technical knowledge of cell therapy processes.

·Record process data and information in a clear/concise format according to proper GDPs.

·Advanced efficiency in working with basic lab equipment, specific Cell Therapy process equipment, and manufacturing logistics systems.

·Author/revise and review documents for facility/equipment and processes within assigned timeline and a high level of competency.

·Completion and ownership of validation activities related to the qualification of the inaugural manufacturing facility suites and process equipment.

·Assists in the development of training material to support the initial and ongoing training of Cell Therapy Manufacturing Personnel.

·Proactively identify and implement opportunities for improvements in process, safety, quality, and cost.

·Lead tech transfer activities related to new product introduction to the manufacturing facility in coordination with functional support teams such as Process/Analytical Development, Tech Transfer, and Client.

·Ensure high levels of communication withtheteam, support resources, and management regarding issue identification and resolution; develop formal communication protocols and tools including progress tracking systems, dashboards and management reports, and any other product specific information as needed.

·Complete same-day review of executed batch records and associated suite documentation.

·Proactively work on resolution of manufacturing deviations/non-conformances for process and equipment problems.

·Escalate key risks and issues to manufacturing line and site leadership team.

·Proven ability to troubleshoot process and equipment issues independently and cross-functionally, as needed.

·Become a qualified trainer and train new Bioprocessing Associates.

·Promote an “All In” culture within the team by exhibiting inclusiveness, emphasizing safety, and leading continuous improvement activities through leading by example.

·Demonstrate a positive attitude within the team and proven ability to complete assignments on time.

Education & Experience

·Bachelor’s degree in biological science(s) field or related engineering is preferred but not required.

·A minimum of 4 years of experience in cGMP biological manufacturing. Cell therapy manufacturing is highly preferred.

·Advanced understanding of cell culture, cryopreservation, and aseptic processing/technique.

·Efficient written and verbal communication skills, with excellent teamwork aptitudes.

·Advanced knowledge of cGMP and FDA regulations.

·Basic mathematical skills

·Advanced efficiency in technical writing capabilities and utilization of documentation management systems.

Familiarity with MS Office applications.

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