What are the responsibilities and job description for the Manufacturing Associate - Cell Therapy position at Dendreon Corporation?
Overview
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.
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
- Associates or Bachlor's Degree in Science highly desired.
Job Requirements
- 2 years of experience exemplifying Good Documentation Practices and Good Manufacturing Practices is required.
- 2 years of experience working in medical device, pharma or biotech is mandatory.
- Must be able to read and understand quality documents.
- Must be able to read, write and communicate fluently in English.
- Must be able to work 12 hour shifts overnight
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.
