Director of Cell Therapy Process Development

Kelly® Science & Clinical is seeking a Director of Cell Therapy Process Sciences for a direct hire opportunity with one of our clients, a commercial-stage biotechnology company. If you’re passionate about bringing the latest scientific discoveries to life and are ready to take the next step in your career, trust The Experts at Hiring Experts.

Salary: $180,000-220,000/year

Workplace: Seattle-based role requiring up to 50% travel.

Overview

This position is responsible for leading the Process Sciences group in the Research and Manufacturing Sciences Department. This position will direct process tech transfer activities for our client’s cell therapy internal and partner programs. This position will also be highly involved with the process development design space, understanding and support commercial manufacturing of the first in class cellular immunotherapy product. The position works closely with manufacturing, quality, regulatory, and project management.

Responsibilities

• Lead and manage a Seattle based team of cellular therapy process development subject matter experts. (SME) that provide technical support by participating on project teams.

• Works with the cross functional operations team to meet timelines for future readiness of new programs.

• Holds overall responsibility for process tech transfer activities for internal and external programs.

• Lead the design and execution of process optimization studies for cGMP manufacture.

• Lead the design and execution of studies to qualify new components and raw materials for use in cGMP manufacture.

• Contributes to a strategic vision around building departmental and company capabilities and resource management.

• Supports business development with technical expertise during project evaluation, preparation of proposals, partner meetings and writing Scopes of Work (SOW).

• Establish and maintain effective relationships with key stakeholders and partners to understand organizational needs to ensure successful project execution and issue resolution.

• Selects, develops, and evaluates personnel to ensure functional objectives are met.

• Provides management with project updates and reports for key business performance indicators.

• Maintains up-to-date knowledge of new equipment and technologies in the industry.

• Promotes individual growth, team health and progressive leadership initiatives.

• Other duties as assigned.

Responsibilities

• Uses professional concepts and company policies and procedures to solve a variety of problems.

• Exercises judgment within defined procedures and practices to determine appropriate action.

• Strong understanding for the end-to-end cellular process development and can discern priorities, escalate issues, and manage exceptions.

• Demonstrates strong verbal and written communications skills and the ability to negotiate with internal and external customers.

• Works on assignments that are extremely complex in nature where independent action and a high degree of initiative are required in resolving problems and developing recommendations.

• Adapts well to a changing environment, is recognized as a team player internally and externally and provides strong customer service to the plant.

• Ensures self and team are always current with new/changing information/guidance and emerging technologies.

Qualifications

• Bachelor’s degree, higher education preferred.

• Minimum of 15 years related experience with operations management and process development activities.

• Demonstrated experience leading and managing a team.

• Experience working in a regulated environment under cGMP is required.

• Proficient with aseptic technique, small- and large-scale cellular therapy processing, cell banking and single use automated equipment.

• Proficient in MS Office applications.

• Expected travel: up to 50%

Once you apply, you’ll proceed to the next steps if your skills and experience look like a good fit. But don’t worry – even if this position doesn’t work out, you’re still in our network. That means our team of expert Science & Clinical recruiters will have access to your profile, making your opportunities limitless.

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As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. Kelly offers eligible employees voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability. As a Kelly employee, you will have access to a retirement savings plan, service bonus and holiday pay plans (earn up to eight paid holidays per benefit year), and a transit spending account. In addition, employees are entitled to earn paid sick leave under the applicable state or local plan. Click here ( for more information on benefits and perks that may be available to you as a member of the Kelly Talent Community.