Associate Director of External Manufacturing Operations (North East) - Caribou Biosciences, Inc.

Caribou Biosciences is a leading clinical-stage CRISPR genome-editing biopharmaceutical company dedicated to developing transformative therapies for patients with devastating diseases. Our next-generation genome-editing technology enables superior precision to develop cell therapies that are armored to potentially improve antitumor activity. We believe the future of cell therapy is off-the-shelf, and we are advancing our pipeline of off-the-shelf, or allogeneic, cell therapies from our CAR-T platform as readily available treatments for patients with hematologic malignancies.

Members of the Caribou herd open their minds to new ideas and welcome diverse perspectives. We proudly assert that teams do their best work when their members are personally engaged, their ideas are taken seriously, and contributions are recognized. Members of the herd work from our headquarters in Berkeley, California, or remotely.

The Associate Director, External Manufacturing Operations, will lead the technical transfer and start-up project for external manufacturing partners. This role involves leading a multi-functional internal and joint team to execute process and analytical transfer, initiation and readiness for cGMP operations, all associated activities and documentation, and comparability & IND amendment content development. Additionally, the AD External Manufacturing Operations will manage the business relationship with the new partner through the project and into ongoing manufacturing operations. This role will report directly to the VP of  Technnical Operations.

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.

Qualifications:

• 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.

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.

General Working Conditions:

• This role will be Northeast US based and include significant on-site availability at the Manufacturing Partner's location, as well as working from home.
• Travel to development labs in Berkeley, California, as well as other manufacturing and testing facilities, will be required from time to time.

Caribou compensation and benefits include:

• Comprehensive compensation package, which includes competitive salary, bonus, and equity for all employees.
• Salary Range: $180,000s - $205,000 - This represents the present low and high end of the Company's pay range for this position. Actual pay will vary based on various factors, including but not limited to location, skill, experience, and performance.
• 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

The benefits and stock purchase described above are subject to the terms and conditions of any governing plans, policies, practices, agreements, or other materials or documents as in effect from time to time, including but not limited to terms and conditions regarding eligibility.

Caribou is an equal opportunity employer and does not discriminate based on race, color, religion, marital status, age, national origin, ancestry, physical or mental disability, medical conditions, veteran status, sexual orientation, gender (including gender identity and gender expression), sex (which includes pregnancy, childbirth, and breastfeeding), genetic information, taking or requesting statutorily protected leave, or any other basis protected by law. In addition, Caribou prohibits the harassment of any individual on any of the bases listed above or any other characteristics protected under federal, state, or local laws.

Legal authorization to work in the United States is required. In compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the United States and to complete the required employment eligibility verification form upon hire.

We do not accept unsolicited resumes or candidate submissions from staffing agencies. All agencies must have a valid written agreement with Caribou Biosciences, Inc.for service in place. Any resume or candidate submitted by a staffing agency without such an agreement in place will be considered unsolicited, and Caribou Biosciences, Inc.  will not be obligated to pay any referral or placement fee.