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. Please visit www.Candeltx.com for additional information.
We are seeking an experienced leader to manage our manufacturing efforts, projects, and strategy in Needham, MA. This career opportunity requires someone who has experience with biologics and desires to be in a startup environment at a growing oncology company. This is a great opportunity for an ambitious, hands-on, and product-driven individual who prioritizes astute technical decisions, inspires, and grows the people around them, and performs best in a dynamic, entrepreneurial environment. You should be highly motivated to help Candel Therapeutics successfully navigate the challenges of bringing our lead product to a BLA filing and successful commercialization. The incumbent will report to the Chief Technical Officer and will be responsible for our internal manufacturing strategies and our external GMP manufacture.
- Oversees all clinical and commercial manufacturing.
- Builds a manufacturing team, provide necessary training and ongoing coaching
- Project management and planning, including coordination between departments
- Drives the development and scaling of manufacturing lines both in-house and with contract manufacturers
- Management of the MFG budget with ability to forecast/track facility and MFG costs
- Troubleshoots process prior to GMP and during GMP manufacturing
- Work closely with QA/QC to ensure high performance of process and product
- Establishes SOPs and batch records for GMP manufacturing
- Executes production and resource schedule against clinical studies schedules and operational plans
- Oversees and coordinates technology transfer of products and processes into the GMP facility
- Develops policies and strategies for GMP manufacturing operations and expansion
- Participates in multi-functional project teams
- Investigates and resolves problems, identifying root cause, and proposing process improvements
- Interacts with outside vendors
- Oversees CMOs to ensure reliable execution with the highest compliance, quality, and regulatory standards to meet program and company goals
- Provides analytical and strategic feedback regarding CMO search and engagement
- Contributes to sections of regulatory submissions relating to CMC
- Advanced degree is preferred with at least 10 years of biotech manufacturing experience, preferably including gene therapy
- Demonstrated CMC expertise
- Experience managing CMOs
- Experience building and leading a team
- Previous small company experience is preferred
- Hands-on, roll-up-your-sleeves approach, with high sense of urgency and drive for results
- Excellent interpersonal skills, personal integrity, professional manner, and ability to gain respect and develop good working relationships with cross functional personnel at all levels
- Strong knowledge of GMP requirements for drug product manufacture and associated analytical activities, as well as broader drug development guidelines (ICH, FDA, EMA).
- Experience in executing complex projects to aggressive timelines with the ability to adapt to rapid changes in project priorities
- A solid track record of establishing a global commercial product supply chain and having had successful interactions with the regulatory agencies
- Experience with Six Sigma preferred
Interested candidates please submit your resume to firstname.lastname@example.org