Research Associate I, Process Development

Overview

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, 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.

Job Summary:

 

The Research Associate I, Cell Process Development supports the development, optimization, troubleshooting, transfer, and validation of cell therapy manufacturing processes. This position performs laboratory-based activities, executes study protocols, analyzes data, and documents results under the guidance of more senior team members while contributing to process improvement and technical support activities.

 

NOTE: This position is based onsite at our Seal Beach, CA facility and requires in-person attendance 5 days per week. THIS IS NOT A REMOTE ROLE.

Responsibilities

• Assist with studies to optimize and/or validate new or improved cell processing methods.
• Perform laboratory experiments and execute study protocols according to approved procedures.
• Support technical investigations related to manufacturing process deviations and failures.
• Assist in documenting investigations in technical reports, memoranda, and other controlled documents.
• Support troubleshooting activities for autologous cellular immunotherapy manufacturing processes.
• Collect, organize, analyze, and present experimental and manufacturing data.
• Perform data entry and verify the accuracy of critical reports and records.
• Conduct bioassays and other analytical procedures used to characterize cellular immunotherapy products.
• Maintain accurate laboratory notebooks, study records, and supporting documentation.
• Assist in preparing technical reports to support process development, technology transfer, and regulatory submissions.
• Draft and revise standard operating procedures (SOPs), work instructions, and laboratory documentation as assigned.
• Support laboratory operations, including equipment maintenance coordination, inventory management, ordering supplies, and vendor interactions.
• Complete all required GMP, safety, and compliance training.
• Follow established safety practices and quality requirements.
• Additional duties, as assigned.

Qualifications

Job Requirements:

• Bachelor's degree in Biology, Cell Biology, Biochemistry, Biotechnology, Biomedical Engineering, or a related scientific discipline is required.
• 0–2 years of relevant laboratory, biotechnology, pharmaceutical, academic research, or cell therapy experience.
• Internship, co-op, undergraduate research, or industry experience is preferred.
• Basic understanding of cell biology and laboratory techniques.
• Experience with cell culture, aseptic technique, or related laboratory processes preferred.
• Familiarity with GMP-regulated environments is preferred.
• Ability to follow detailed procedures and maintain accurate documentation.
• Strong analytical and problem-solving skills.
• Effective written and verbal communication skills.
• Strong organizational and time-management skills.
• Proficiency with Microsoft Office applications.
• Ability to work collaboratively in a team environment.

Working Conditions and Physical Requirements:

• Primarily laboratory and office-based environment.
• May require extended periods of standing and walking in laboratory and manufacturing support 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
• Required use of personal protective equipment (PPE), including laboratory coats, gloves, safety glasses, and other designated protective equipment.
• Ability to safely handle biological materials and laboratory reagents.
• Ability to use computers, mobile devices, and standard office equipment.
• Ability to communicate effectively in person, by phone, and through written correspondence.
• 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 – 25 lbs
• May require occasional schedule flexibility to support study or manufacturing activities.
• Ability to gown aseptically for work in Clean Room environments