Overview

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 Beal, 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:

Supervises cGXP Facilities Maintenance services including planning and maintenance of equipment.

Responsibilities

Your Work:

• Supervises cGXP Facilities Maintenance services including planning and maintenance of equipment which may include one or more of the following:
  • Develops SOPs, test reports and out of tolerance notifications.
  • Conducts failure analysis, root cause determination and corrective action determination.
  • Generates quality maintenance reports.
  • Directs or leads investigations re: deviations, out of tolerance conditions and unexpected results.
• Contributes to the development of department budget.
• Oversees the coordination of building space allocation and layout, communication services and facilities expansion.
• Represents Facilities in cross-functional teams and projects.
• Selects, develops and evaluates personnel to ensure functional objectives are met.
• Receives assignments in the form of objectives with goals/measures predefined. Provides guidance to employees according to established policies and management directives. Work is reviewed by management to measure meeting of objectives. Administers company policies that directly affect staff members. Recommends changes to area policies.
• Works on problems of moderate scope in which analysis of situation or data requires review of identifiable factors. Exercises judgment within defined procedures and policies to determine appropriate action. Acts as advisor to area supervisors; becomes actively involved as required to meet schedules or resolve problems.
• Erroneous decisions or failure to achieve results will cause delays in schedules.
• Frequently interacts with direct reports, outside customers and functional peer groups at various management levels. Interaction normally requires the ability to gain cooperation of others, conducting presentations of technical information concerning specific projects/schedules, etc.
• Provides immediate supervision or assigns tasks to a unit or group of employees. Provides general or direct supervision to exempt employees and/or skilled nonexempt employees. A portion if the time may be spent performing individual tasks.

Qualifications

Education Requirements:

• Bachelor’s degree in an engineering discipline or equivalent.

Job Requirements:

• Typically 5 years of related experience in cGXP/FDA regulated industry.
• Typically 2 years leadership experience.
• Knowledge of cGXP/ICH/FDA regulations.
• Proficient in MS Office applications.

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.