TEMP Manufacturing Operations Associate - Union City

Job Title

Aseptic Manufacturing and Assembly

Job Description

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 Beach, CA and Union City, GA. A sizeable Research & Development group based out of Seattle, WA, and a highly skilled Commercial team countrywide.

Your role involves aseptic manufacturing and assembly of clinical and commercial human blood derived components in a clean-room environment (Class 10,000/ISO7, and Class 100,000/ISO8). This is a temporary role.

Please note: This role has an overnight shift of 9:30pm - 9:30am. Monday, Tuesday, & Friday.

Responsibilities

Your work includes:

• Weighs, measures and checks raw materials to ensure batches manufactured contain proper ingredients and quantities.
• Maintains records to comply with regulatory requirements and acts as subject matter expert for revisions or improvements to manufacturing documents.
• Works with other Cell Processing Associates utilizing good manufacturing practices during aseptic processing of clinical and commercial products using Standard Operating Procedures.
• Represents department in cross-functional teams, projects and GXP-related problem resolution.
• Posts weights and shipping charges, and prepares goods for final shipment.
• Prepares and maintains records of merchandise shipped.
• Prepares goods for final shipment and unpacks and checks goods received against purchase orders and invoices, maintains records of received goods, rejecting unsatisfactory items if necessary.
• Examines, stocks, and distributes GMP and non-GMP materials to inventory and manufacturing lines.
• Perform other duties as assigned.

Scope:

• Applies job skills and company policies and procedures to complete a wide range of tasks.
• Works on assignments that are moderately complex in nature where judgment is required in resolving problems and making routine recommendations.
• Normally receives general instructions on routine work, detailed instructions on new assignments.
• Uses ability as a skilled specialist in accordance with company policies and procedures to compete complex tasks in creative and effective ways.
• Works on assignments that are complex in nature where considerable judgment and initiative are required in resolving problems and making routine recommendations.
• May determine methods and procedures on new assignments and may provide guidance to other support personnel.
• Ability to be flexible and support all functions by readily responding to changing circumstances (i.e. shift changes) and business needs.

Qualifications

• 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 25 pounds. Limited exposure to (2C - 8C); (-20C); (-75C); (-196C) 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.