What we do.

Vision – Pioneering the future of immunotherapy.

Mission – Making the battle against cancer personal through immunotherapy treatments that extend lives.

How we do it.

The Dendreon Way. We are a purpose-driven, value-based culture. At Dendreon, we…

• 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.
• Raise the Bar: Harness continuous improvement, foster innovation and elevate our people.
• Drive Results. Be accountable and execute – we win when everyone performs.

Are you ready?

• Manages QC equipment maintenance with vendors and department staff. This includes working with vendors on service contracts, initiating requisitions, managing on-demand work orders and performing routine equipment maintenance as needed.
• Coordinates with Procurement to maintain service agreements, blanket purchase orders.
• Perform basic troubleshooting of instrument systems to assist with identifying issues and implementing proper corrective actions to minimize the downtime of instruments and to ensure ability for timely patient testing is not impacted.
• Oversees projects that involve QC instrumentation, including initiating and owning quality change controls, and working cross-functionally and across sites to validate and implement new systems.
• Initiates non-conformances and conducts investigations as needed to address issues
• Ensure timely assessment and closure of NCs and Change Control requests
• Ensure timely assessment and closure of Laboratory Investigations
• Participate in audits of site operations
• Gathers metric information for use in continuous improvement of area of responsibility. Assist in interpretation of metric data.
• Revises and updates standard operating procedures
• Performs validation testing as needed to support implementation of new instruments or changes in instrument software.
• Reviews and approves equipment calibration reports.
• Adheres to good documentation practices to ensure data integrity and traceability.
• System administrator for all QC laboratory systems (Met One, MXP, WinKQCL, Observa/BacT, NC-200, others as required).
• Perform other duties as required.

• Uses professional concepts and company policies and procedures to solve a variety of problems.
• Accountable for security administration of a large variety of software systems under increasing data integrity requirements
• Works on problems of moderate scope in which analysis of situation or data requires a review of identifiable factors. Exercises judgment within defined procedures and practices to determine appropriate action.

• Bachelor’s degree in a scientific discipline or equivalent.
• 4+ years related experience in cGMP/FDA regulated industry.
• Knowledge of basic lab testing techniques.
• Analytical skills to evaluate and interpret data to arrive at logical conclusions.
• Attention to detail, quality and compliance with strict adherence to test procedures and protocols.
• Ability to learn new technologies and processes quickly and to understand the operational concepts of each equipment used in the laboratory.
• Knowledge of cGMP/QSR/ICH and FDA device/drug/biologics regulations preferred.
• Proficient in MS Office applications.
• Excellent interpersonal, verbal and written communication skills are essential in this collaborative work environment.
• Able to adjust workload based on changing priorities.

• Ability to sit or stand for extended periods of time
• Ability to regularly lift 10-20lbs, and up to 50 lbs. Limited exposure to (2ºC - 8ºC); (-20ºC); (-75ºC); (-196ºC) areas.
• Ability to be flexible with schedule
• 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.