Director, Process Sciences Cell Therapy

Who we are.

Dendreon is making the battle against cancer personal. Our flagship product PROVENGE® (sipuleucel-T), was the first FDA approved immunotherapy for the treatment of metastatic castrate resistant prostate cancer and is made from the patient's own immune cells.

If you are looking to positively impact the lives of patients, we want you to join our team. We have Immunotherapy Manufacturing Facilities located in Seal Beach, CA and Union City, GA. A sizeable Research & Development group based out of Seattle, WA, and a highly skilled Commercial team countrywide.

Core Values:

• Put Patients First. Every day is a new opportunity to improve the lives of patients living with cancer.
• Act with Integrity. Be honest, transparent, and committed to doing what’s right in every situation.
• Build Trust. Building trust takes time. Engage teammates, be candid and transparent. Over communicate and seek feedback.
• Raise the Bar. Harness continuous improvement, foster innovation and elevate our people.
• Drive Results. Be accountable and execute – we win together when everyone performs

Your Role:

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 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, PROVENGE. The position works closely with manufacturing, quality, regulatory, and project management.

Functional Area: Research and Development

Your Work:

• 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 Dendreon 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

Scope:

• 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.
• Does not require general instructions on routine work, detailed instructions are only provided on new assignments.
• Strong understanding for the end to end cellular process development and is able to 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.

• 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%

Working Conditions and Physical Requirements:

• Ability to sit or stand for extended periods of time 
• Intermittent walking to gain access to work areas
• Finger dexterity sufficient to use a computer and to complete paperwork activities
• Vision sufficient to use a computer, to read written materials and to complete paperwork activities.
• Hearing sufficient to communicate with individuals by telephone and in person
• Ability to lift up to 25 pounds. Limited exposure to (2ºC - 8ºC); (-20ºC); (-75ºC); (-196ºC) areas.
• Must have the ability to work around laboratories, manufacturing areas and equipment, and regularly lift 10 – 20 lbs. and lift up to 50 lbs.
• May be required to work alternate shifts
• Ability to gown aseptically for work in Clean Room environments
• Job performed in a lab, office, or utility (noisy) environment
• Must have the ability to work around laboratories, manufacturing areas and equipment with exposure to blood, blood products or OPIM (other potentially infectious materials) while donning required personal protective materials.
• Dendreon is an EEO/AA employer M/F/D/V.