Scientist I – Cell Process Development, Process Science

Dendreon Corporation•Seattle, WA

34d•Onsite

About The Position

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 in Seattle, WA, and a highly skilled Commercial team across the nation, Dendreon is at the forefront of cancer treatment innovation. The Scientist will technical expertise and problem-solving skills to develop, transfer and troubleshoot processes to manufacture cell therapies. The scientist in this position will be hands on in the laboratory and report to the Manager of Process Development. A strong interpersonal and communication skills with a collaborative, team-first mindset is a must.

Requirements

BS, MS, or Ph.D. in Molecular Biology, Biochemistry, or a related field.
A Ph.D. with 2+ years of hands-on experience in molecular biology analysis or a BS/MS with 8+ years of significant practical experience in molecular biology.
Working knowledge of cGMP requirements.
Ability to solve problems through analysis.
Excellent written and verbal communication skills.
Strong organizational skills required.
Proficient in MS Office applications.
Familiarity with method development, qualification, and technology transfer in a regulated environment.
Experience with scaling processes

Nice To Haves

Experience with cell culture techniques, especially iPSC, is a plus.
Working knowledge of different bioreactor technologies such as, PBS vertical wheel reactors, Xuri and stirred tank reactors

Responsibilities

Responsible for developing, validating and troubleshooting cell processes.
Utilize various cell culture platforms such as Prodigy, Xuri, G-Rex, Hyperstack, and stirred tank reactor to develop and scale-up clinical cell therapy processes, as required
Design and conducts process optimization studies for CMC and IND readiness
Design and conducts studies to qualify new components used in the manufacture of cell therapies
Support the transfer of new or optimized cell process to internal or external manufacturing organizations
Write, review and may approve documents such as technical reports, SOPs, validation protocols, validation reports and scientific manuscripts.
Perform functionally based bioassays and flow cytometry to characterize cell therapies.
Provide cell process technical support to the Manufacturing Group by participating on project teams.
Review and may approve protocols, procedures and reports, as appropriate.
May act as subject matter expert (SME) on cell process development during non-conformance investigations and regulatory inspections.
Performs, documents and analyzes experimental data that examines the characteristics of cell therapy processes
Maintain study records and document results in technical reports.
Write, revise, review and may approve operating procedures, as appropriate.
Complete appropriate GMP training, when needed.
Document investigations in reports and memoranda, as appropriate.
Other duties as assigned.