Manufacturing Sciences & Technology (MS&T) Co-op
Beam is seeking a highly motivated Engineering Co-Op within the Manufacturing Sciences & Technology (MS&T) team to support technology transfer and cGMP implementation of cellular therapy manufacturing processes at our new RTP site from January through June of 2023. The successful candidate will be responsible for providing operational and technical support for cellular therapeutic processes within the site.
As a key member within the new RTP site, this role will play a key role in the development of technical and operational documents in support of site and program specific control strategies. As the site transitions to clinical and future commercial cGMP production of novel cellular based therapeutics, this role will provide technical support to manufacturing, contribute to the readiness for process validation, and provide process technical support to other cross functional NC site teams as needed. Additionally, this role may engage with cross-functional CMC team members to support and execute the CMC agenda, including IND or BLA authorship support, as appropriate.
Supports MS&T activities related to autologous and allogeneic cell therapy programs (g. CAR-T, CAR-NK).
Supports the technology transfer and implementation of cell therapy programs, collaborates with sending and receiving site cross-functional team members
Contributes to the development of site control programs such as process monitoring plan, microbial control plan, aseptic process qualification and sterility assurance programs
Contributes to the establishment of technical documentation including tech transfer plans, facility fit and gap analysis reports, manufacturing study protocols and reports, standard operating procedures, process validation master plans/protocols/report, risk assessments, etc.
Contributes to historical clinical data collection, monitoring, and analysis. Presenting and reviewing data with cross-functional teams
Leads and/or assists with manufacturing deviation investigations, CAPA, and change controls
Must be willing to have a flexible schedule during initial site start up and/or program start up, which may include supporting critical operations outside of normal work hours, as needed
Candidates must be a currently enrolled student pursuing a Bachelor's or Master’s degree in Chemistry, Biology (g. Cell Biology, Virology), Biochemistry, Chemical/Biological Engineering, Pharmaceutical Science or a related discipline.
Candidates must have completed at least (2) years of studies toward bachelor’s degree by Jan 2023
Strong communication, troubleshooting, and problem-solving skills
Desirable Skills and Knowledge
Prior experience with cell cultures or cell/gene therapies is a plus
Experience supporting the technology transfer, implementation of complex biologics processes process, and validation for cell culture processes
Exposure to drug development and regulatory requirements, process validation lifecycle CAPA and RCA
The candidate should have a solid academic foundation in engineering, science and mathematics coursework (examples: biology/chemistry/biochemistry, engineering principles, biochemical/bioengineering, reactor design/lab, molecular biology, etc.)