TEMP Manufacturing Operations Associate

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 talented team of scientific, clinical, regulatory, and corporate professionals based in Seal Beach, and a commercial organization operating across the United States, Dendreon continues to advance innovation in personalized cancer treatment.

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.

JOB SUMMARY:

Manufacturing Operations Associates 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.

NOTE: This role entails an overnight shift of: Monday, Tuesday, and Friday - 9:30pm - 9:30am

Key Responsibilities:

• Works with other Manufacturing Operations Associates 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

JOB REQUIREMENTS:

Required Qualifications

• High school diploma or equivalent.
• Ability to read and understand quality-related documentation.
• Ability to read, write, and communicate effectively in English.

Preferred Qualifications

• Associate’s, technical, or bachelor’s degree in a science-related field.
• Previous experience in the medical device, pharmaceutical, biotechnology, or other regulated industry.
• Previous experience working in a GMP/cGMP-regulated or FDA-regulated environment.

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.

Beware of Recruitment Scams

Please be aware of the potential for scams from individuals, organizations and internet sites that claim to represent Dendreon Pharmaceuticals in recruitment activities. We strongly recommend that you verify all communications you receive about positions at Dendreon. Any communications from Dendreon would come from an email address that ends in “@dendreon.com”. Dendreon will never ask candidates to provide any type of payment, bank details, photocopies of identification, social security number or other highly sensitive personal information during the recruitment or offer process. Dendreon conducts a formal recruitment process for all authorized positions posted and does not conduct interviews via social media, or other third-party sites or chat services. If you are unsure about a posting or email you receive, please contact us at AskHR@dendreon.com. If you believe you are a victim of fraud, please contact your local law enforcement.