Sr. Assoc. Scientist, Process and Product Development (Contract)

About the role

Allogene is seeking a highly motivated Senior Associate 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 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
• MS plus at least 2 years experience or BS with at least 5 years experience
• A demonstrated foundational understanding of mammalian or primary cell culture, biochemistry, molecular & cell biology and immunology (required for enhanced product & process understanding).
• Experience with prior Gene & Cell Therapy manufacturing preferred, but not required.
• Experience with continuous manufacturing processes including operation in upstream genetic modification and bioreactor/WAVE expansion, and cryopreservation preferred.
• Experience in genetic modification of cells using gene edit and gene delivery technologies preferred, but not required.
• Experience in flow cytometry for T cells characterization preferred, but not required.
• Experience in FMEA, process characterization and DOE methodologies in biologics or cell therapy space preferred.
• 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.

Qualifications

Candidates must be authorized to work in the U.S.

Benefits

The expected hourly range for this role is $45 to $50 per hour. Actual pay will be determined based on experience, qualifications, geographic location, business needs, and other job-related factors permitted by law.

Equal Opportunity Employer

We offer a chance to work with talented people in a collaborative environment and provide a top-notch compensation and benefits package, which includes an annual performance bonus, equity, health insurance, generous time off (including 2 annual holiday company-wide shutdowns) and much more.