Location: South San Francisco, CA
Reports to: Director Cell Therapy Process Engineering
The role is responsible for supporting the planning, execution, and technical support of manufacturing process scale-up and technology transfer project tasks/activities, in which ex vivo modified cell therapy drug substance and drug product operations are transferred from Process Development to Manufacturing in order to produce quality product at cGMP manufacturing scale in support of both clinical and future commercial programs
JOB DUTIES AND RESPONSIBILITIES:
· Actively manages relationship with various internal functions including Manufacturing, Quality, and Facilities as well as manage or act as person in plant (PIP) to provide technical process development and process engineering oversight and troubleshooting of manufacturing issues as they arise.
· Develops, leads, and performs scientific and engineering analysis for drug product handling, administration, and in-use stability studies.
· Oversees and performs all functions associated with cell therapy process technology transfer and process monitoring and support, e.g. develop process understanding, generate bill of materials (BOM), perform gap analysis / failure mode effect and analysis (FMEA), generate process models author/review detailed process flow diagrams (DPFD), perform process monitoring (manufacturing data summary and analysis, data presentation), author campaign summary reports, and perform activities for lot release (assess deviations and process changes)
· Authors and reviews process descriptions, batch records, raw material listings, change controls independently and authors/reviews/modifies the corresponding templates
· Supports CMC as a functional team representative and assisting in manufacturing clinical deviations and change controls.
· Supports the development of project plans and effectively communicate progress and key deliverables to management.
· Mentors and provide training to junior staff.
· Embodies the company culture of empowerment, diversity, and inclusion.
· Lift up to 50Lbs
· MS (preferred not required) in Bioengineering, Biomedical Engineering, Process Engineering and 6+ years of biopharmaceutical industry experience in a development setting or PhD degree in Bioengineering, Biomedical Engineering, Process Engineering with 4 + years of biopharmaceutical industry experience in a development setting.
· Significant biotech industry experience supporting cell therapy process engineering, process scale up, tech-transfer, manufacturing, preferably with either ex vivo modified cells or stem cell process development or manufacturing experience
· Experience with cell therapy manufacturing support, and experience implementing current Good Manufacturing Practices (GMP), US / EU regulations
· Experience with flow cytometry, preferred
· Experience with cell culture work
· Experience with suspension bioreactors
· Excellent communication skills, both written and oral, and high degree of organization in terms of goal setting and achieving
· Willingness to travel up to 10%