Manufacturing Operations Associate - Union City, GA

Employer
Dendreon
Location
Greater Atlanta Area
Posted
Aug 19, 2021
Ref
2021-2086
Required Education
High School or equivalent
Position Type
Full time

Who we are.

Dendreon is making the battle against cancer personal. Founded on the belief that the immune system holds the key to the future of cancer care, Dendreon is committed to the delivery of treatments that harness the power of the body’s immune system to attack cancer cells.

If you are looking to positively impact the lives of patients, we want you to join our team. Headquartered in Seal Beach, California, and with sizable locations in Union City (Greater Atlanta), Georgia and Seattle, Washington, as well as countrywide Commercial and Medical Science Liaisons teams, we have a diverse offering of exciting opportunities.

What we do.

Vision – Pioneering the future of immunotherapy.

Mission – Making the battle against cancer personal through immunotherapy treatments that extend lives.

How we do it.

The Dendreon Way.  We are a purpose-driven, value-based culture. At Dendreon, we…..

  • 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. 
  • Raise the Bar:  Harness continuous improvement, foster innovation and elevate our people.
  • Drive Results. Be accountable and execute – we win when everyone performs.

Are you ready?

Our high-performing organization challenges, develops, and rewards employees interested in pushing past typical career limitations. If you are passionate about helping patients and looking for a unique career opportunity, view our open positions to apply or refer a friend today.

Job Summary: Manufacturing Operations Associates 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. 

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
  • 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
  • Undergo and maintain required training

Responsibilities:

  • 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.
  • Other duties as assigned

 

We also need you to:

  • Demonstrate the highest level of integrity at all times
  • Have the demonstrated ability to follow written work instructions and standard operating procedures (SOPs)
  • Be a team player and have a proven ability to work in a fast paced environment.
  • Have a demonstrated ability to quickly learn technical things.
  • Have demonstrated ability to work through and around obstacles and challenges.
  • Be highly proactive and disciplined to manage time effectively.
  • Have a strong results orientation and a high level of resiliency.
  • Be available to work 3rd shift 

Job Requirements:

  • High school diploma with 3-5 years of stable work history OR Associates/Technical Degree.
  • BA/BS degree in Science. 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.