Xcyte Therapies, Inc.

Director, GMP Operations

Xcyte Therapies, Inc., a Seattle-based biotechnology company, is developing and commercializing novel cell-based or cellular therapeutic products that harness the power of the immune system to treat cancer and many infectious diseases.

This person will be responsible for directing manufacturing, material control, and facilities policies, staff and practices for a state-of-the-art manufacturing facility for cell-based therapeutics. The successful candidate will participate in the design, construction and validation of the Bothell Manufacturing Facility, oversee commissioning of the GMP facility and participate in the structuring of an equipment validation and maintenance program. Manage the technology transfer process for process improvements facility changes, and secondary vendor qualifications to include coordination of input from FDA for prospective protocols and participate in the evaluation and development of new processes and technologies for clinical programs.

This position requires a PhD or equivalent, and 7 plus years experience in cGMP biopharmaceutical operations, ideally in a commercial setting. Significant prior interaction with the FDA is required, including experience with the preparation of CMC sections of IND, BLA or NDA submissions. Thorough experience based understanding of facility design requirements, cGMP and FDA requirements required. In-depth experience of cell cultivation/cell processing/ cell-based therapeutics is a must. Qualified candidates will have a willingness to travel, demonstrated ability to effectively lead projects with internal and/or external resources, excellent organizational and management skills with strong leadership ability.

Please send resumes to:

Xcyte Therapies, Inc.
Attn: Human Resources
1124 Columbia Street, Suite 130
Seattle, WA 98104
Fax: 206-262-0900
Email: hr@xcytetherapies.com

Xcyte Therapies, Inc. is an Equal Opportunity Employer

Submitted: 04/20/2004