The Cellular Immunotherapy GMP Manufacturing Department is looking for a talented Staff Scientist for manufacturing process / analytical development for cellular immunotherapy manufacturing. The staff scientist will be an integral member of GMP manufacturing team to in charge in-process testing for routine manufacturing productions and process development. The staff scientist who will develop, optimize, validate and characterize cellular product manufacturing platforms to ensure the consistency, reproducibility, and quality of manufacturing process. The staff scientist candidate will ideally have expertise in the field of immune cell biology, experience in automation system for cell manufacturing, particularly with experience in DOE for process development and have the knowledge of Current Good Manufacturing Practice (cGMP). This position will also lead a team to collaborate with different groups from QA, QC, and research scientists in developing cell manufacturing process and performing tech transfer to enable IND submission for clinical applications.
Key Responsibilities include:
Use of DOE to effectively develop / optimize /validate process in GLP environment to successfully meet project goals.
Perform product characterizations by performing adequate analytical methods
Ability to critically interpret experimental results, finalize reports and present data in a clear and concise manner.
Establish protocols and writing SOPs for process development and cGMP manufacturing
Acts as internal/external Subject Matter Expert (SME) for manufacturing process/analytical related technical issues and provides technical support to Manufacturing, in-process testing and to third party clients.
Develop training program and conduct training for staffs
Develop process control plans including new equipment qualification and process change control plans.
Data entry of all patient/product information and testing into a computer database and generate reports.
Ability to participate in the preparation of IND submissions, grant applications and scientific publications.
Cooperate with Quality Control (QC) and Quality Assurance (QA) groups to ensure the regulation compliance.
Meticulous attention to detail and accuracy in lab work and documentation, strictly following established SOPS, as well as accurate record keeping and lab documentation.
Assist in internal inspections and audits to ensure compliance with Federal Drug Administration (FDA) regulations and City of Hope and CTPC procedure requirements.
Provide supervision and training to junior team members as directed by supervisor.
Required to wear pager, or other communication devices, to respond promptly to emergency calls and for critical equipment failure.
Complete and maintain all training required by City of Hope and CTPC.
Cooperate with other performance improvement and compliance activities within the department and in the institution.
Maintains current knowledge of manufacturing/analytical techniques and industry practices.
Practice a high level of integrity and honesty in maintaining confidentiality.
Providing routine lab support and maintenance activities in the spirit of GLP.
Excellent oral and written communication skills.
Basic education, experience and skills required for consideration:
Ph.D. degree in life or biomedical sciences with 2 years post-degree research experience or Master's degree in biological science or related field, with at least 6 years of post-degree research experience or Bachelor's degree in biological science or related field, with at least 8 years of post-degree research experience.
Extensive hands-on mammalian cell culture experience.
Extensive process development experience
Extensive hands-on cGMP experience.
Biotechnology or pharmaceutical industry experience.
Good written and oral communication skills, team player, self-motivated, excellent personal hygiene.
Practice good judgment in all professional activities.
Ability to analyze data and compose reports.
Ability to develop and update policies and procedures.
Ability to set and model professional work standards.