Manufacturing Science and Technology Scientist II

Our Culture: Why work with us?

Our most valuable resource is our people--with a diversity of backgrounds, ideas, opinions, and life experiences. There’s a dedication to one another that’s palpable. We hire kind, smart, creative, passionate professionals who are always learning and teaching. We’re incredibly proud that as we’ve grown, our vibrant culture has remained steadfast. We continue to build a culture of collective hard work without egos. Leaders are transparent, accessible, honest, authentic, and invest in their employees.“We’re all in this together,” is our company’s mission.

Our Science:

Candel Therapeutics is a clinical-stage biotechnology company pioneering the development of viral based immunotherapies for the treatment of solid tumors. Candel’s products are designed to significantly help patients fight their cancer while maintaining quality of life – from early - to late-stage disease. We have a robust pipeline with clinical assets in phase 1, 2 and 3 for the treatment of prostate, brain, lung and pancreatic cancers. Please visit www.Candeltx.com for additional information.

A day in the life of this role:

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
  
  

What’s in it for you:

Joining a team that is focused on delivering life changing products to patients, you will be provided with a great opportunity to take ownership of the supply chain department. You will develop strategy and drive it to completion with the support and help of a strongly knit team who are determined to deliver products to patients.

• You will work as part of a cross functional CMC team, driving to provide cutting edge lifesaving products to people in need. You’ll get to support the writing of the critical regulatory filings that help get the product to patients
• Access to multiple viral platforms at multiple CMO, where opportunities are available for Upstream, Downstream, and Drug Product activities. Depending on the candidate ownership of the entire process stream
• Identification of CMO partners, to ensure consistent supply of clinical and commercial products
• Work with a team on the cutting edge of viral vector science, supporting our Enlighten platform
• Opportunity to work supporting Characterization, PPQ, and IND/BLA Filing efforts
  
  

What we need from you:

• A Bachelor’s degree in Engineering or a related field with 7-10 years of experience in Manufacturing or Process Development
• Previous experience tech transfer, and ICHQ8 methodology
• Ideally previous experience in executing characterization studies and statistical methods for process modeling
• Ideally previous experience supporting IND and BLA development and submissions
• A love for solving puzzles and troubleshooting process issues that can at times be quite complex.
• 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
• Grit: You have a “can do” attitude and don’t mind rolling up your sleeves and pitching in. You always go above and beyond
• Intellectual curiosity: You enjoy thinking deeply. You have a thirst for learning. You relish in sharing knowledge and know how to have fun doing so!
• Daring: You are comfortable take risks and (appropriately) pushing boundaries. You work hard and challenge the status quo.
• Comradery: You build genuine relationships. You trust your co-workers. You truly enjoy working together and understand we are all more successful when we work as a team
  
  

Powered by JazzHR

eTAuzeVJU6