Caribou Biosciences is hiring a
Associate Director of External Manufacturing Operations

Summary

Join our team as the Associate Director, External Manufacturing Operations, and lead technical transfer and start-up projects for external manufacturing partners. This role involves managing business relationships, leading cross-functional teams, and ensuring seamless process and analytical transfers.

Requirements

• Bachelor's degree in a relevant scientific or engineering discipline
• Minimum of 10 years' experience in the Biotech/Cell & Gene Therapy (C>) space with extensive exposure to technical transfers, manufacturing operations, and manufacturing technical support
• Proven experience in technical transfer and start-up of cGMP manufacturing operations
• Strong experience with US and EU CMC regulatory expectations, technical transfers, complex development & manufacturing activities, and commercial manufacturing
• Ability to rapidly learn technical processes and understand process development and analytical development processes and issues
• Excellent people manager and cross-functional leader, able to lead diverse and complex teams with demonstrated success
• Strong project management skills with the ability to lead cross-functional teams
• Excellent communication and interpersonal skills, with the ability to build and maintain effective relationships with external partners
• In-depth knowledge of regulatory requirements and guidelines for cGMP manufacturing
• Ability to work independently and as part of a team in a fast-paced, dynamic environment

Responsibilities

• Active hands-on management of both technical and business activities for a new critical manufacturing partner
• Leadership of a multi-functional project team that will oversee and execute all aspects of transfer and start-up activities
• Leadership of a joint project team that will collaborate closely with the partner to ensure execution of all associated activities
• Act as the first point of contact for the partner to ensure full-time, highly focused ongoing support and a positive relationship
• Provide leadership and inputs to broader Tech Ops strategies including VMP, PPQs, INDs, BLA, etc. to ensure full alignment with partner operations
• Oversee start-up projects for external manufacturing partners, ensuring readiness for cGMP operations
• Coordinate a multi-functional internal and joint team to ensure seamless process and analytical transfer
• Develop and manage all associated activities and documentation to support manufacturing operations
• Ensure comparability and support IND amendment content development as required
• Manage and nurture the business relationship with new external manufacturing partners throughout the project lifecycle and into ongoing operations
• Collaborate closely with cross-functional teams including Quality, Regulatory, Supply Chain, and R&D to ensure alignment and successful project execution
• Monitor and report on project progress, identifying and mitigating risks to ensure timely delivery of project milestones
• Implement and maintain best practices in external manufacturing operations to ensure high-quality and compliant manufacturing processes

Preferred Qualifications

• Experience with CAR-T, or other cell & gene therapy manufacturing processes
• Prior experience managing business relationships with external manufacturing partners
• Knowledge of genome-editing technologies and their application in biopharmaceutical manufacturing
• PMP or other project management certification

Benefits

• Comprehensive compensation package, which includes competitive salary, bonus, and equity for all employees
• Salary Range: $180,000s - $205,000
• Generous paid vacation time, in addition to company-observed holidays and floating holidays
• Excellent medical, dental, and vision insurance
• 401(k) retirement savings plan, which includes matching employer contributions
• Employee stock purchase plan (ESPP)
• Tuition reimbursement program