Senior Manager/Associate Director, Adoptive Cell Therapy Supply Chain
KSQ Therapeutics, United States
Job Description
What if... we were able to transform drug discovery into a dramatically more efficient, less expensive, and more precise process?
It turns outWe can generate uniquely powerful insights into disease biology by leveraging CRISPR-based technologies in new and creative ways.
KSQ’s unique advantage stems from its proprietary CRISPRomics platform that enables us to define the precise role of each human gene across a multitude of diseaseswith unprecedented speed and certainty. Come help us systematically decode the genome and rewire human biology to deliver therapies to patients that are waiting.
Overview:
KSQ Therapeutics is seeking a collaborative and highly motivated leader to build and manage the infrastructure needed to ensure uninterrupted clinical supply of our first cell therapies. This will include oversight of donor tissue supply networks and establishment of chain of custody/identity for autologous cell therapy products. You will work closely with internal and external stakeholders, including Manufacturing, Clinical Operations, Process and Analytical Development, Manufacturing Sciences, Ramp;D, Quality, Finance, and Legal partners. This is an opportunity to become an integral part of our work to bring KSQ adoptive cell therapies to patients!
Key Responsibilities:
- Establish and manage infrastructure for clinical supply of autologous cell therapy products
- Implement and manage system for supply planning of drug product runs, including inventory of starting materials and custom raw materials
- Collaborate with internal/external manufacturing and clinical partners to ensure successful execution of distribution amp; logistics for patient material
- Oversee donor tissue supply networks across vendor and academic collaborations
- Select, implement, and manage distribution amp; logistics approaches (e.g., couriers, packaging technology solutions)
- Select and implement a patient material traceability software solution
- Manage contract terms for external partners
- Design and implement a supplier relationship management program to include ensuring regular business reviews
- Compile information needed to support regulatory filings
Requirements
- Degree in science, engineering, or biotechnology-related field with 8+ years of applicable experience
- Previous experience in supply chain management for clinical or commercial products, cell amp; gene therapy preferred
- Previous experience supporting negotiating and contracting operational partnerships
- Familiarity with operational use of Quality Systems, including risk management, change control, deviation management, root cause analysis, and CAPA management
- Solid financial acumen with strong analytical skill and problem-solving ability
- Strong influencing capabilities with an ability to effectively interact and communicate at all levels of an organization
- Effective project management skills
- Hybrid work from home/office per current KSQ policy
- Travel lt;10%