Scientist, Drug Product Process Development (Contract)

Allogene Therapeutics; South San Francisco (CA); On-site; USD 69,000 - 80,000; Full time

Job summary

Allogene Therapeutics, based in South San Francisco, seeks a Scientist to develop and characterize clinical-scale CART manufacturing processes.

You will implement state-of-the-art processing technologies and support tech transfer for GMP manufacturing, contributing to future CART manufacturing needs.

Qualifications

• BS in Chemical Engineering, Biochemistry, Molecular & Cell Biology, or Immunology or related degree with at least 8 years process development experience
• MS plus at least 5 years process development experience
• Foundational understanding of mammalian or primary cell culture, biochemistry, molecular & cell biology
• Experience with JMP DOE methodologies in biologics or cell therapy space preferred
• Ability to work in a fast-paced startup environment
• Authorized to work in the U.S.

Responsibilities

• Develop and implement robust CART manufacturing processes and DoE studies.
• Execute DoE studies (preferably with JMP) to support process understanding and optimization.
• Support clinical-scale non-GMP manufacturing for characterization activities.
• Support process characterization efforts and continuous improvement in manufacturing capabilities.
• Contribute to project teams and communicate with stakeholders.
• Maintain high-quality documentation and contribute to regulatory filings.
• Present data to scientists and management in internal meetings.
• Stay current with literature in cell therapy and bioprocessing.
• Perform other duties as assigned.

Skills

Process development

DoE (JMP)

Team collaboration

Documentation

Independent work

Education

BS in Chemical Engineering / Biochemistry / Molecular & Cell Biology / Immunology

MS with 5+ years process development

Tools

JMP

Bioreactor/WAVE

Job description

About Allogene:

Allogene Therapeutics, with headquarters in South San Francisco, is a clinical-stage biotechnology company pioneering the development of allogeneic chimeric antigen receptor T cell (AlloCAR T) products for cancer and autoimmune disease. Led by a management team with significant experience in cell therapy, Allogene is developing a pipeline of "off-the-shelf" CAR T cell product candidates with the goal of delivering readily available cell therapy on-demand, more reliably, and at greater scale to more patients.

About the role:

Allogene is seeking a highly motivated Scientist to support the development and characterization of clinical-scale manufacturing processes for Allogene's CART therapies. This individual will contribute to the development, implementation and characterization of state-of-the-art processing technologies to deliver scalable and robust manufacturing processes, and support successful tech transfer for GMP manufacturing and release. This position will also contribute to the development of novel technologies and approaches to meet future CART manufacturing needs.

Responsibilities:

• Actively contribute to development, implementation, characterization and successful execution of robust, state-of-the-art CART manufacturing processes.
• Execute and analyze (ideally with JMP software) Design of Experiments (DoE) studies to support process understanding, optimization, and characterization activities.
• Support clinical-scale non-GMP manufacturing operations for execution of BLA-enabling process characterization activities.
• Support and contribute to process characterization efforts and continuous improvement initiatives aimed at enhancing CAR-T manufacturing processes and capabilities (e.g., evaluation of process parameters, materials, closed or disposable systems, and operational workflows).
• Contribute to Project Technical Teams and communicate and collaborate effectively to ensure effective interactions with all stakeholder groups.
• Ensure high-quality, timely documentation in electronic laboratory notebooks and Technical Reports and contribute to Regulatory Filings and responses to Regulatory questions as appropriate.
• Present data/strategy to scientists (and management) in internal venues (technical meetings, Project Team meetings) as appropriate.
• Remain current with relevant cell therapy, immunology, and bioprocessing literature.
• Other duties as assigned

Requirements:

• BS in Chemical Engineering, Biochemistry, Molecular & Cell Biology, or Immunology or related degree with at least 8 years process development experience
• Or MS plus at least 5 years process development experience
• A demonstrated foundational understanding of mammalian or primary cell culture, biochemistry, molecular & cell biology
• Experience with prior Gene & Cell Therapy manufacturing / process development preferred, but not required.
• Experience in JMP DOE methodologies in biologics or cell therapy space preferred.
• Experience with continuous manufacturing processes including operation in upstream genetic modification and bioreactor/WAVE expansion, and cryopreservation preferred, but not required.
• Ability to execute technical projects with complex problem solving and critical thinking
• Ability to work in a fast-paced, startup environment.
• Strong attention to detail with the ability to multi-task and handle multiple responsibilities simultaneously.
• Excellent organizational skills and an ability to prioritize effectively to deliver results within reasonably established timelines.
• Ability to work independently and as part of a team.
• Strong interpersonal skills including verbal and written communication are essential in this collaborative work environment.
• Candidates must be authorized to work in the U.S.
• This is a 1-year contract opportunity with the possibility of extension or contract-to-hire.

We offer a chance to work with talented people in a collaborative environment. The expected hourly range for this role is $50 to $58 per hour. Actual pay will be determined based on experience, qualifications, geographic location, business needs, and other job-related factors permitted by law.

As an equal opportunity employer, Allogene is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job-related characteristics or other prohibited grounds specified in applicable federal, state and local laws. We also embrace differences in experience and background, and welcome diversity of opinions and thought with active recruitment and internships designed to create a stronger and better Allogene that is focused on developing life-changing products for patients.