Reporting to the Manager, Clinical Manufacturing, this Contractor will participate in the day-to-day manufacturing of cellular supply for the company’s clinical programs and participate in pre-clinical supply campaigns as required.
- Participate in the daily manufacturing of the company’s cell therapy products. Operate in ISO 7 and ISO 8 (Class 10,000 and Class 100,000) manufacturing environments. Ability to gown appropriately for clean room/aseptic manufacturing is required.
- Work cohesively with Clinical Manufacturing and Quality Control teams in support of operational efficiency and flexibility and assurance of timely completion of all manufactured cell therapies. Maintain and deliver sufficient supply of appropriate grade material for clinical studies in accordance with timelines and participate in clinical supply campaigns.
- Execution and daily completion of multiple batch records. Ability to adhere to Good Documentation Practices.
- Participate in the process development, training and process transfers for existing and future products. Execute protocols to support manufacturing operations.
- Ensure the proper operation and performance of routine manufacturing equipment. Completion of multiple equipment logbooks is required.
- Routinely prepare and maintain cell culture reagents and media.
- Ability to perform frequent physical tasks with strength and mobility. Daily tasks call for extensive walking and standing in cleanroom environments and occasional lifting of heavy materials.
- As required, participate in the manufacturing environment cleaning program and work to assure all manufacturing suites, equipment and critical environments are cleaned on scheduled and per qualified methods
- .Ability to consistently perform various manual laboratory duties and techniques on time sensitive material with accurate and precise manipulations.
- Excellent verbal and written communication skills as well as strong focus and attention for details is required.
BS./M.S. in Biology, Bioengineering or related scientific discipline.
Ideal candidate will have 1+ years’ relevant experience with manufacturing in cGMP environments.
Academic experience will be considered.
Understanding of federal regulations for Quality Systems (21CFR820) and GMP manufacturing (21CFR 210,211).
- Demonstrated scientific creativity, technical proficiency and knowledge of scientific concepts
- Strong organizational and time management skills
- Dynamic individual with the ability to communicate and engage others
- Independent and self-starting. Ability to work with minimal supervision
- Flexible schedule. Ability to work holidays and weekends, when needed.