Research Associate I, Process Development

Dendreon Corporation

  • Seal Beach, California
  • 10 days ago
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    Skills

    • Academic Researchunmatched
    • Analysis Skillsunmatched
    • Asepsisunmatched
    • Biochemistryunmatched
    • Biological Assayunmatched
    • Biomedical Engineeringunmatched
    • Biotech and Pharmaceuticalunmatched
    • Cancerunmatched
    • Cell Biologyunmatched
    • Cell Culturesunmatched
    • Cleanroomunmatched
    • Clinical Researchunmatched
    • Communication Skillsunmatched
    • Continuous Improvementunmatched
    • Data Analysisunmatched
    • Data Entryunmatched
    • Diseaseunmatched
    • Document Managementunmatched
    • Documentationunmatched
    • Equipment Maintenance/Repairunmatched
    • FDA (Food and Drug Administration)unmatched
    • GMP (Good Manufacturing Practices)unmatched
    • Identify Issuesunmatched
    • Inventory Managementunmatched
    • Laboratoryunmatched
    • Laboratory Notebookunmatched
    • Laboratory Operationsunmatched
    • Laboratory Techniquesunmatched
    • Lift/Move 25 Poundsunmatched
    • Manual Dexterityunmatched
    • Manufacturingunmatched
    • Manufacturing/Industrial Processesunmatched
    • Microsoft Officeunmatched
    • Mobile Devicesunmatched
    • Office Equipmentunmatched
    • Operational Supportunmatched
    • Order Suppliesunmatched
    • Organizational Skillsunmatched
    • Physical Demandsunmatched
    • Presentation/Verbal Skillsunmatched
    • Problem Solving Skillsunmatched
    • Process Developmentunmatched
    • Process Improvementunmatched
    • Prostate Cancerunmatched
    • Protocol Analysisunmatched
    • Regulatory Submissionsunmatched
    • Reporting Skillsunmatched
    • Research & Development (R&D)unmatched
    • Research Protocolsunmatched
    • Safety/Work Safetyunmatched
    • Standard Operating Procedures (SOP)unmatched
    • Team Playerunmatched
    • Technical Supportunmatched
    • Time Managementunmatched
    • Writing Skillsunmatched

    Description

    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

    Numbers & Facts

    LocationSeal Beach, California

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