What are the responsibilities and job description for the Manufacturing Associate - Cell Therapy - Talent Pool position at Dendreon Corporation?
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
Manufacturing Operations Associate (aka Cell Therapy Specialists) in our Commercial Manufacturing division are the heart and soul of our organization as they are responsible for the manufacturing of Provenge (Sipuleucel-T) product in a clean-room environment. Provenge is manufactured using the patients' blood, personalizing the treatment.
Please Note: This position has daily manufacturing responsibilities that are in a ISO controlled cleanroom environment (non-laboratory setting) that will require frequent gowning of personnel protective equipment.
Responsibilities
Your Work
- Works with other Cell Therapy Specialists utilizing current good manufacturing practices (cGMPs) to aseptically manufacture commercial products using Standard Operating Procedures (SOPs).
- Ensures right-the-first-time performance of all process steps specific to the phase or stage of operation. Escalates processing and equipment issues as needed.
- Weighs, measures and checks raw materials to ensure batches manufactured contain proper ingredients and quantities.
- Rigorously adheres to SOPs and cGMP regulations to accurately complete paper and electronic records associated with commercial manufacturing.
- Reviews in-process cGMP documentation for completeness and accuracy.
- Unpacks and checks materials received against specifications, maintains records of materials used and rejects unsatisfactory items when necessary.
- Prepares products for final shipment and maintains records of products shipped.
- Examines, stocks, and distributes GMP and non-GMP materials to inventory and manufacturing lines.
- Helps drive the safety-first culture
- Applies job skills and company policies and procedures to complete a narrow range of tasks.
- Works on assignments that are simple in nature, escalates issues when required, and making routine recommendations.
- Normally receives general instructions on routine work, detailed instructions on non-routine and new assignments.
- Ability to be flexible and support all functions by readily responding to changing circumstances (i.e. shift changes) and business needs.
- Other duties as assigned
Qualifications
Education Requirements
- High School Diploma
- Associates/Technical/BA/BS degree in Science preferred
Job Requirements
- No prior industry experience required
- Experience in medical device, pharma or biotech preferred
- Must be able to read and understand quality documents
- Must be able to read, write and communicate fluently in English
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 50 pounds. Limited exposure to (2ºC - 8ºC); (-20ºC); (-75ºC); (-196ºC) areas.
- 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.
