Technical Specialist, Materials
Manufacturing | El Segundo, CA | Full Time
Kite, a Gilead Company, is a biopharmaceutical company based in Santa Monica, California. Kite is engaged in the development of innovative cancer immunotherapies with a goal of providing rapid, long-term, durable response and eliminating the burden of chronic care. The company is focused on chimeric antigen receptor (CAR) and T cell receptor (TCR) engineered cell therapies designed to empower the immune system’s ability to recognize and kill tumors. For more information on Kite, please visit www.kitepharma.com.
The Technical Specialist, Materials will have overall responsibility for support a biotechnology facility in El Segundo that includes general laboratories for bio-processing. Under minimal supervision, this position will be focused on the manufacturing operations compliance and documentation activities and closely collaborates with the Quality Unit.
Responsibilities (include but are not limited to):
- Manage and track deviations within the Materials Management department.
- Coordinate efforts across multiple departments to gather supporting justification data to determine appropriate corrective and preventative actions.
- Initiate change control as related to investigations, procedural changes, and other system/equipment upgrades.
- Support internal/external inspections by completing responses and tracking commitments.
- Create and revise SOPs for materials management, shipping, receiving, and kitting processes.
- In conjunction with various internal and external stakeholders, investigates and coordinates the resolution of deviations/investigations through comprehensive Root Cause Analysis tools.
- Represents Materials Management operations in change control, CAPA, and deviation meetings.
- Devises and implements CAPAs to address root cause and ensure effectiveness.
- Collaborating with technical and operational stakeholders, writes and/or revises SOPs, batch records, and other operational related documents
- Trends key performance metrics
- Participates in internal audit/inspection
- Conducts training
- Manages specific projects to meet established timelines.
- Other tasks and duties as assigned by Management.
- Bachelors’ Degree in life sciences with 5 to 7 years of related professional experience
- Understands shipping and receiving processes, knowledge of aseptic processing experience required
- Experience leading projects is required
- Broad technical knowledge of cGMP compliance and experience with leading investigations, writing, deviation reports, change controls, and corrective actions
- Experience with investigation and root cause analysis tools
- Skilled at creating and delivering presentations
- Technical writing
- Provides training and guidance to others
- Experience leading cross functional teams
- Facilitates cross functional and team meetings.
- Knowledge of ERP systems implementation is desirable
- Proficiency in using Microsoft Word, Excel, Presentation, Access, and Project is required.
- Excellent interpersonal, verbal and written communication skills are essential in this collaborative work environment
- High energy level and a positive outlook coupled with the requisite “can do” attitude and a willingness to do what it takes to achieve personal and organizational goals and overcome obstacles
- Willingness to think outside of the box and adapt best practices to our small, but growing environment
- Ability to adapt in a constantly evolving environment
- Self-motivated with a strong sense of ownership in areas of responsibility
Kite, a Gilead Company, is an equal opportunity employer based in Santa Monica, CA. Kite offers the opportunity to be part of a successful, fast growing company in a cross functional and collaborative environment.
To learn more about us, please visit our website at www.kitepharma.com
No phone calls please and no agencies or recruiters.