TEMP Manufacturing Operations Associate - Union City

Dendreon Pharmaceuticals LLC; Union City (CA); On-site; USD 36,000 - 48,000; Full time

Job summary

Dendreon Pharmaceuticals LLC in Union City, GA, is seeking a temporary aseptic manufacturing associate to assemble clinical and commercial components in a clean-room environment.

The role involves weighing materials, maintaining records, following SOPs, and collaborating with cross-functional teams.

Overnight shift 9:30pm–9:30am, Monday, Tuesday, and Friday; opportunity to support multiple functions with GMP practices.

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.

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.
• Perform other duties as assigned
• 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.

Job description

WHO WE ARE** :**

At Dendreon,we’retransforming 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,utilizinga 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:

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.

NOTE:

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

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.
• Perform other duties as assigned
• 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.

JOB REQUIREMENTS:

Required Experience & Skills:

• 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 (2ºC - 8ºC); (-20ºC); (-75ºC); (-196ºC) 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.