We are partnered with a developing biotech who are looking to bring on a Senior Director of Operations. They have built up their facility from a team of 12 to 55. The Senior Director of Operations will be a strategic leader responsible for overseeing the operations of the company's manufacturing and supply chain activities for cutting-edge cell and gene therapies. you will play a critical role in driving operational excellence across all stages of product development and commercialization, ensuring the efficient, compliant, and scalable production of life-saving therapies.
Key Responsibilities:
- Lead and oversee all operational activities related to the development, manufacturing, and commercialization of cell and gene therapies, including process development, production, quality control, and supply chain management.
- Develop and execute the operational strategy to support product development timelines, clinical trials, and global commercialization efforts.
- Manage the day-to-day operations of GMP-compliant manufacturing processes, ensuring adherence to quality standards, regulatory requirements, and operational goals.
- Provide leadership and guidance to cross-functional teams, including Manufacturing, Supply Chain, Quality, and Regulatory, to align on business objectives and ensure successful execution of operational strategies.
- Oversee the establishment, scale-up, and optimization of manufacturing processes for cell and gene therapies, ensuring the production of high-quality, cost-effective products.
- Lead internal and external manufacturing operations, including overseeing contract manufacturing organizations (CMOs) and partners.
- Implement and manage technology transfer processes to ensure smooth handoffs between R&D, process development, and commercial manufacturing operations.
- Identify opportunities to improve manufacturing efficiency, capacity, and cost-effectiveness while maintaining product quality and compliance.
- Develop and manage the end-to-end supply chain strategy, including sourcing of raw materials, logistics, and distribution to support clinical and commercial production.
- Ensure timely availability of high-quality materials for manufacturing and clinical trials, while optimizing inventory levels to minimize risk of stock-outs or overstocking.
- Work closely with external partners to ensure reliable and efficient transportation and distribution of products, especially for patient-specific therapies that require special handling.
- Develop contingency plans to mitigate supply chain risks, including disruptions in raw material availability, transportation challenges, or manufacturing delays.
- Ensure all operations are fully compliant with GMP, regulatory guidelines (e.g., FDA, EMA), and industry standards for cell and gene therapy production.
- Lead efforts to establish and maintain robust quality management systems (QMS) to support operations in alignment with global regulatory requirements.
- Work closely with the Quality Assurance (QA) and Quality Control (QC) teams to ensure consistent quality and batch-to-batch reproducibility.
Experience:
- Masters or an advanced degree (MBA, MS, or Ph.D.) in Life Sciences, Biotechnology, Engineering, or a related field.
- 15+ years of experience in biopharmaceutical or biotechnology operations, with at least 5 years in a leadership role overseeing manufacturing, supply chain, or operations within cell and gene therapy or biologics.
- Extensive experience with GMP manufacturing, process development, technology transfer, and commercialization of cell and gene therapies, including viral vector production, cell-based therapies (e.g., CAR-T), or gene editing.