Research Associate I, Process Development

Dendreon Corporation•Seal Beach, CA

7d•$53,963 - $70,511•Onsite

About The Position

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.

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.
Basic understanding of cell biology and laboratory techniques.
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.
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

Nice To Haves

Internship, co-op, undergraduate research, or industry experience is preferred.
Experience with cell culture, aseptic technique, or related laboratory processes preferred.
Familiarity with GMP-regulated environments is preferred.

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.