Manufacturing Science and Technology Scientist I/II

Candel Therapeutics

Needham, MA, USA

Published: 6/14/2022

Healthcare

Full Time

Job Description

Job DescriptionThis is a hybrid role in Needham, MA office
Salary: $143K – $155K

Our Culture: Why work with us?
At Candel, our people drive our success. We value diversity, collaboration, and bold thinking in a supportive, mission-driven environment. Like a team, we show up for each other and stay focused on making a difference for patients and families. Our leadership is transparent and empowering, and our culture is built on trust, flexibility, and accountability, encouraging ownership and innovation every day.

Our Science: Advancing Cancer Immunotherapies
Candel is a clinical-stage biopharma company developing off-the-shelf, multimodal immunotherapies that stimulate personalized, systemic anti-tumor responses. Our platforms use genetically modified adenovirus and HSV constructs. With positive Phase 3 results for our lead candidate, it’s an exciting time to join us and help bring transformative cancer treatments to patients. Learn more: www.candeltx.com 

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
Support IND and BLA development for our most advance program

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 with 7-10 years of experience in Manufacturing or Process Development, with a focus on upstream operations at a biotech company ( MUST HAVE)
HEK and Vero Cell experience a plus
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.

What will make you successful at Candel:

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.

Applicants must be legally authorized to work in the United States at the time of hire and throughout employment. We are unable to provide, assume, or sponsor work visas or employment authorization for this role now or in the future.

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