Manufacturing Science and Technology Scientist I/II
About The Position
This is an exciting time to join Candel Therapeutics as we just received positive Phase III results on our lead candidate. You will get to drive some of the late stage workstreams to help launch a life changing product. In this role you will act as a process owner, supporting external efforts for development and production of clinical and commercial materials. Ensure successful transfer of viral vector bioprocesses into GMP production at CMO. Opportunities exist across all of the manufacturing areas, from media and buffer development through the Drug Product fill. Supervise production campaigns and report on progress as person in plant. Function as manufacturing process lead for all or portions of the process in CMC team Manage process development activities at CMO for scale up and manufacturability, project timelines, identify risks, and escalate issues to Tech ops and CMC as needed. Design and support characterization studies and PPQ protocols for late-stage programs Support IND and BLA development for our most advance program
Requirements
- A Bachelor’s degree with 7-10 years of experience in Manufacturing or Process Development, with a focus on upstream operations at a biotech company ( MUST HAVE)
- Previous experience tech transfer, and ICHQ8 methodology
- Strong communication skills, excited to work in a team-based format. A person who isn’t afraid to take a shot and looks for support to keep learning.
Nice To Haves
- HEK and Vero Cell experience a plus
- Ideally previous experience in executing characterization studies and statistical methods for process modeling.
- Ideally previous experience supporting IND and BLA development and submissions
Responsibilities
- Act as a process owner, supporting external efforts for development and production of clinical and commercial materials.
- Ensure successful transfer of viral vector bioprocesses into GMP production at CMO.
- Supervise production campaigns and report on progress as person in plant.
- Function as manufacturing process lead for all or portions of the process in CMC team
- Manage process development activities at CMO for scale up and manufacturability, project timelines, identify risks, and escalate issues to Tech ops and CMC as needed.
- Design and support characterization studies and PPQ protocols for late-stage programs
- Support IND and BLA development for our most advance program
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Number of Employees
11-50 employees
