Senior Manager, Patient Operations & Supply Chain Logistics

Ksq Therapeutics - Lexington, MA

Full-time - Senior

Lexington, MA

About the position

At KSQ Therapeutics, we are dedicated to understanding the role of every human gene in various diseases, tissues, and cells. This comprehensive approach has led to the creation of a vast, experimentally derived dataset that has proven to be remarkably predictive of past successes and failures in oncology and immuno-oncology product development. Our commitment to this methodology has allowed us to identify numerous opportunities for the development of new medicines, prompting significant investments in distinct, highly validated pathways for drug development. We aim to create breakthrough products that can significantly impact patient care. Founded in late 2015, KSQ is a clinical-stage biotech company that has rapidly advanced the field of CRISPR-enabled functional genomics. Our journey has taken us from in vitro cell autonomous screens to more complex genome-scale screens of immune cells in vivo. We have expanded our technology's scope to include multiple cell types and explore areas beyond oncology. Our leadership team comprises accomplished industry experts in drug discovery and development, driving our mission forward. In this highly visible role, the Senior Manager of Patient Operations & Supply Chain Logistics will lead patient operations and supply chain activities that support all pre-clinical and clinical programs. This position is crucial as we scale the company in preparation for late-stage clinical and commercial launches. The Senior Manager will serve as the single point of contact for managing and logistics of patient drug product manufacturing activities, which includes overseeing tumor collection, manufacturing, and patient infusion in close collaboration with clinical study sites and clinical operations team members. Additionally, the role involves setting up the infrastructure for logistical management of patient drug product manufacturing across multiple sites in the United States and eventually globally. The Senior Manager will also support non-clinical, clinical, and commercial supply/demand planning efforts for all raw materials and consumables, ensuring compliance with quality expectations and industry guidelines in Good Manufacturing Practice (GMP) and Good Documentation Practice (GDP), as well as knowledge of Good Clinical Practices (GCP).

Responsibilities

• Lead patient operations and supply chain activities supporting pre-clinical and clinical programs.
• Serve as the single point of contact for management and logistics of patient drug product manufacturing activities.
• Oversee tumor collection, manufacturing, and patient infusion in collaboration with clinical study sites and clinical operations team members.
• Set up infrastructure for logistical management of patient drug product manufacturing at multiple sites in the U.S. and globally.
• Support non-clinical, clinical, and commercial supply/demand planning efforts for raw materials and consumables.
• Ensure compliance with quality expectations and industry guidelines in GMP and GDP.

Requirements

• BS/BA in a science or engineering field.
• Minimum of eight years of experience in cell therapy supply chain, patient operations, or manufacturing.
• Demonstrated leadership in cross-functional teams with internal and external partners.
• Relentless patient focus and continuous improvement mindset.
• Excellent attention to detail, project and time management skills.
• Ability to manage multiple competing priorities with aggressive timelines.
• Track record of ownership and accountability.
• Experience in building, maintaining, and optimizing cell therapy supply chain infrastructure, including ERP, patient tracking, traceability, and labeling.