Senior Manufacturing Process Engineer

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. Join our rapidly growing company where you will work in an environment that values innovation, scientific rigor and a “can do” attitude. We care deeply about our team, our patients, and our community. We have a robust pipeline of investigational drug candidates in phase 1, 2 and 3 clinical trials in prostate, brain, lung, and pancreatic cancers. Candel is a newly public company having completed its IPO at the end of July 2021. Please visit www.candeltx.com for additional information.

This is an exciting time to join Candel Therapeutics as we are almost finished with construction for our first manufacturing suites/labs, and you will be one of the first employees to work in our new facility.

In this role, you will help support our new manufacturing facilities and equipment, starting with qualification of a newly constructed manufacturing facility.  The role will also include the development of maintenance plans and metrology programs.  You will be able to take on the responsibility -with the help of the director of manufacturing- for the selection and qualification of new process equipment.

Responsibilities:

You will be provided with a great opportunity to expand your knowledge and scope of a traditional engineering role.  You will be able to support the facility utilities, process equipment, as well as develop a maintenance and metrology program.  In this highly visible position, you will also have opportunities to support process scale up and tech transfer as well as manufacturing strategy with the Director of Manufacturing and Chief Technical Officer.

  • You will work closely with a cross functional CMC team, driving to provide cutting edge lifesaving products to people in need. You’ll get to support the writing the critical regulatory filings that help get the product to patients
  • You will support new equipment start-up and operation. You’ll play a lead role in the entire equipment life cycle; from identifying and purchasing the right unit, straight through making sure it’s ready for manufacturing use when its needed. This includes things like developing the user requirements, commissioning, and validating the for use, and the steps between to keep the unit in control.
  • You will keep the process running at its best. Demonstrating some problem-solving skills, here you will help by providing technical assessments on deviations and investigations and design the best path forward with Corrective and Preventative actions.
  • You will help keep the equipment running at its best. Provide troubleshooting and solution guidance when issues in the facility, equipment and systems arise; Perform spare parts assessments, implement preventive and corrective maintenance plans, and oversee calibration and metrology programs.
  • You will work collaboratively with PD team to deliver new products into the manufacturing through facility fit analysis and scale up activities.

Requirements:

  • A Bachelor’s degree in Engineering or a related field with 3 to 7 years of experience in a highly regulated environment, particularly cGMP
  • A love for solving puzzles and troubleshooting equipment 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.

Corporate Culture:

A fundamental belief held by the Candel Therapeutics team is that we have the best chance to achieve our mission by bringing together our collective problem-solving and leadership skills into a single, collaborative front. We look for people who envelop competence and self-awareness, retain the courage to state thoughts, wants and needs, and have the ability to make good judgment calls and decisions. We want people who are undeterred by uncertainty, convert adversity into opportunity, and turn understanding into action while driving motivation for the team at large.  Please visit www.candeltx.com for more information.

We offer a competitive compensation and benefit package with opportunities to participate in groundbreaking technology.  For consideration, please submit CV.

Interested candidates please submit your resume to careers@candeltx.com