Candel Therapeutics is a clinical-stage biotech company developing oncolytic viruses as immunotherapy for various solid tumors types.
Reporting to the CEO, the Chief Technical Officer will be a key member of Candel’s senior leadership team with a high degree of visibility and impact across the organization. The successful candidate will bring a strong strategic mindset and has a proven track record of success in leading a company’s technical operations, including process and analytical development, cGMP Clinical and Commercial Manufacturing, quality systems, and the development of CMC consistent with regulatory requirements. The successful candidate will embrace innovation in a fast-paced environment and has previously demonstrated ability to quickly build and implement high quality, high output scalable technical operations.
- Develop and implement Manufacturing Science and Engineering Technical strategies for clinical and commercial manufacturing of oncolytic viral therapies.
- Ensure success of all production activities and projects including tech transfer, facility build-out, commissioning, qualification, and facility start-up, process control and stewardship, and life cycle management.
- Responsible for long-range strategic planning and implementation for oncolytic virus clinical and commercial manufacturing, development, and management of Candel’s manufacturing, technical and engineering teams to drive the product-specific technology strategy, from development of clinical through commercial manufacturing.
- Champion the culture of quality and ensure that all activities and documentation comply with regulatory requirements. Understand and implement processes, controls, and methods that align with global Health Authority regulatory expectations.
- Build a high performing team by recruiting and developing talent, ensuring the development and implementation of training required to fully qualify process development, including analytical and manufacturing staff for establishing and maintaining capable Process Control Strategy.
- Lead and develop a strong team-based culture, fostering commitment to excellence through transparent communication and staff engagement.
- Drive operational excellence, flawless execution, and continuous improvement.
- Participate in the evolution of the company’s overall business strategy, in addition to developing and driving Candel’s technical operations strategy.
- Remain current regarding technical manufacturing requirements and ensure that the technical operations department develops and modifies production methods consistent with these requirements.
- Lead the manufacturing team in operations, regulatory preparedness planning and client and regulatory agency visits and inspections.
- Management of Contract Organizations
- 10+ years progressive experience in a key leadership/management role in pharmaceutical development and commercial manufacturing related to gene therapy
- Deep understanding of the science and technology underlying biological and virus manufacturing as well as analytical techniques that support clinical and commercial manufacturing activities
- Demonstrated understanding of the principles and applications associated with commercial manufacturing operations, process control strategy, process robustness, and process engineering for gene therapies
- Strong knowledge of cGMP requirements
- Demonstrated track record of success in preparing and defending CMC submissions for FDA and foreign regulatory inspections and approval
- A strategic thinker with strong result-orientation and a sense of urgency to deliver quality results on time and in a highly ethical and professional manner
- Strong understanding of the technical aspects of manufacturing, testing, and controls, the regulations governing gene therapy operations, as well as financial systems and controls
- Motivational leadership of a cohesive high-performing team within a global, highly matrixed environment; the ability to articulate vision and successfully drive execution
- Excellent communication and interpersonal skills with the ability to build strong cross-functional relationships and communicate complex issues and concepts enterprise-wide, from the executive team to the manufacturing floor and the process and analytical development laboratory environment
- Excellent team player and be able to build and sustain organization respect and trust at all levels
- Problem solver with a hands-on approach and ability to anticipate adverse scenarios and provide contingency plans to address them
- Resilient and able to work well in a demanding, fast paced entrepreneurial environment
- Sound judgment and business acumen with personal versatility and flexibility as business and team evolve
- Keeps current on professional knowledge, expertise and best practice
- Advanced degree in biological or engineering disciplines with minimally 10 years of relevant experience in biotech or pharmaceutical industries, ideally in a senior manufacturing and process development technical leadership role within the gene therapy industry
- MS/MA degree in Biological Sciences, Chemical Engineering, Chemistry or related discipline and at least 15 years of related experience; or
- PhD degree in Biological Sciences, Chemical Engineering, Chemistry or related discipline and at least 10 years of related experience
- Experience with Biological products and gene therapy technologies is critical
Interested candidates please submit your resume to email@example.com