Manufacturing Support Associate (Union City) - (Work Shift: Sun, Mon & Tues 4am-4pm)

Who we are.

At Dendreon, we’re transforming the battle against cancer with personalized immunotherapy. Our flagship product, PROVENGE® (sipuleucel-T), was the first FDA-approved immunotherapy for metastatic castrate-resistant prostate cancer, utilizing a patient’s own immune cells to fight the disease.

If you’re driven by the opportunity to make a meaningful impact on cancer patients' lives, we invite you to join our team. With Immunotherapy Manufacturing Facilities in Seal Beach, CA, and Union City, GA, a strong Research & Development group in Seattle, WA, and a highly skilled Commercial team across the nation, Dendreon is at the forefront of cancer treatment innovation.

Core Values: 

• Put Patients First: Every day is an opportunity to improve the lives of those living with cancer.
• Act with Integrity: We commit to transparency, honesty, and always doing what’s right.
• Build Trust: Trust is earned through candid, open communication and a collaborative approach.
• Raise the Bar: We embrace continuous improvement and innovation, always striving to elevate our people.
• Drive Results: We are accountable to each other and deliver success together.

Your Role:

This position's shift is Sunday/Monday/Tuesday 0400 - 1600

In this role you will:

• Spend the majority of your day fully gowned in a clean room environment
• Follow standard operating procedures to aseptically process clinical and commercial products
• Perform cleaning activities following Good Manufacturing Processes (GMP) in ISO and CNC classified areas
• Maintain accurate and timely records in compliance with regulatory requirements
• Performs inventory control duties such as, checking goods received against purchase orders and invoices and preparing goods for final shipment

Your Role:

• Checks raw materials to ensure batches manufactured contain proper ingredients and quantities.
• 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.
• Cleans GMP and CNC production areas once GMP manufacturing is completed daily
• Maintains records to comply with regulatory requirements and acts as subject matter expert for revisions or improvements to manufacturing documents.
• Works with other manufacturing Associates utilizing good manufacturing practices during aseptic activities using Standard Operating Procedures.
• Represents department in cross-functional teams, projects, and GXP-related problem resolution.
• Other duties as assigned
• Applies job skills and company policies and procedures to complete a wide range of tasks.
• 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.

Required Experience & Skills:

• High School Diploma or equivalent required
• Working in a Manufacturing or Distribution Center environment preferred
• Demonstrated and documented high-quality performance, demonstrated ability to work successfully in a team environment and excellent attention to detail. Basic computer skills required to include MS Outlook, MS Word, and web-based computer applications. Warehouse Management System experience preferred, BPCS a plus.

Preferred Experience:

• Typically, 2 years related experience in cGMP/FDA regulated industry

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)
• 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.