Scientist I – Cell Process Development, Process Science

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 in Seattle, WA, 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 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.

Key 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.

Scope:

• Uses professional concepts, company policies and procedures to solve a variety of problems.
• Works on problems of complex scope.
• May introduces applicable principles to the team and orients them on appropriate usage.
• Establishes new principles with usage guidelines and training as appropriate.
• Works with minimal supervision.

Job Requirements:

Education:

• BS, MS, or Ph.D. in Molecular Biology, Biochemistry, or a related field.

Experience:

• 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.
• 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
• 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

Working Conditions and Physical Requirements:

• On-site based role at our Seattle, WA office (NOT Remote)
• This role operates in a standard office setting using standard office equipment.
• Role requires frequent use of video conferencing, standard office software, and digital collaboration tools.
• Must have the ability to lift 10 – 20 lbs.
• Must have the ability to work in an office environment around laboratories, manufacturing areas and equipment with exposure to blood, blood products or OPIM (other potentially infectious materials) while donning required personal protective materials.