Principal Scientist, Process Sciences

Allogene Therapeutics; South San Francisco (CA); On-site; USD 155,000 - 180,000; Full time

Benefits offered by this job

Annual performance bonus

Equity

Health insurance

Generous time off

Holiday shutdowns

Job summary

Allogene Therapeutics in South San Francisco is seeking a Principal Scientist to lead the Pilot Plant within Process & Product Development. You will translate development strategies into robust, at-scale cell therapy manufacturing operations and guide cross-functional teams including Drug Product, MSAT, and Manufacturing.

The role requires strong scientific leadership, experience with scale-up, DOE, and data-driven decision making, and the ability to drive technology transfer to GMP.

Qualifications

• Ph.D. in Chemical Engineering, Bioengineering, Biochemistry, Molecular & Cell Biology, Immunology, or related field with 7+ years of industry experience.
• Extensive experience in process development and scale-up for biologics or cell therapy manufacturing.
• Experience with DOE and data-driven decision making.
• Experience using Python or R for data analysis and automation development.
• Experience supporting regulatory filings (IND/BLA) and PPQ/process validation.
• Proven track record leading complex programs and cross-functional initiatives.
• Strong leadership, mentorship and cross-functional collaboration skills.
• Authorized to work in the U.S.

Responsibilities

• Lead the Pilot Plant team and oversee large-scale and engineering runs.
• Translate development strategies into scalable at-scale cell therapy operations.
• Ensure alignment across development, pilot, and manufacturing for GMP transfer.
• Design and execute high-impact process development studies using QbD.
• Identify and mitigate scale-dependent risks in manufacturing platforms.
• Apply fluid dynamics, gas and mass transfer concepts to scale-up.
• Develop closed, aseptic automation strategies and optimize platform-specific systems.
• Drive end-to-end process integration for thaw, activation, expansion, fill/finish.
• Serve as primary Process Sciences interface with Drug Product, Manufacturing, MSAT.
• Document results in ELNs and technical reports; contribute to regulatory filings.
• Mentor scientists in study design, data interpretation, and decision-making.
• Stay current with cell therapy, immunology, and bioprocessing literature.
• Other duties as assigned.

Skills

Leadership

Project management

Team mentoring

Data analysis

Education

PhD in Chemical Engineering / Bioengineering / Biochemistry / Molecular & Cell Biology / Immunology or related field

Tools

Python

R

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 Principal Scientist to lead the Pilot Plant function within Process & Product Development (PPD). This individual will serve as a technical and operational leader responsible for translating process development strategies into robust, scalable pilot-scale operations.

This successful candidate will leverage deep expertise in process development and scale-up to lead complex studies, guide organizational strategy, and drive cross-functional integration with Drug Product, MSAT, and Manufacturing. This role requires strong scientific leadership, operational execution, and the ability to influence programs across the organization.

Responsibilities include, but are not limited to:

• Lead the Pilot Plant team, overseeing execution of large-scale and engineering runs in support of process development, characterization, and technology transfer.
• Translate process development strategies into robust, executable at-scale cell therapy manufacturing operations.
• Ensure alignment across development, pilot, and manufacturing functions, enabling robust technology transfer to GMP.
• Lead the design and execution of high-impact process development and characterization studies using QbD principles.
• Identify and mitigate scale-dependent risks associated with cell therapy manufacturing platforms (e.g., Sepax, Xuri, Prodigy, etc.), ensuring robust process performance upon scale-up.
• Apply engineering principles, including fluid dynamics and gas and mass transfer, to support process understanding, scale-up, and robust manufacturing performance.
• Develop and implement closed, aseptic, automation strategies, including equipment/system evaluation, programming and optimization of cell therapy platform-specific systems.
• Drive end-to-end process integration, including thaw, activation genetic engineering, cell expansion, and fill/finish unit operations and associated at-scale equipment.
• Serve as the primary Process Sciences interface with Drug Product, Manufacturing, and MSAT functions.
• Ensure high-quality, timely documentation in electronic laboratory notebooks and Technical Reports and contribute to Regulatory Filings and responses to Regulatory questions as appropriate.
• Author and/or oversee preparation of technical reports, regulatory documents (i.e. IND/BLA sections), and scientific publications.
• Interpret complex datasets and communicate results to cross-functional teams and senior leadership.
• Act as a technical mentor, coaching scientists on study design, data interpretation, and scientific decision-making.
• Remain current with relevant cell therapy, immunology, and bioprocessing literature.
• Other duties as assigned

Position Requirements & Experience:

• Ph.D in Chemical Engineering, Bioengineering, Biochemistry, Molecular & Cell Biology, Immunology or related field with at least 7 years of relevant experience required; or MS with at least 10 years of industry experience; or BS with at least 12 years of industry experience.
• Extensive experience in process development and scale-up for biologics or cell therapy manufacturing.
• Demonstrated expertise in process characterization, DOE, and data-driven decision making.
• Experience using Python or R for analysis of complex datasets and development of automation solutions for cell therapy manufacturing platforms.
• Strong understanding of cell therapy manufacturing processes (i.e. gene editing, viral transduction, cell expansion, formulation).
• Experience supporting regulatory filings (IND/BLA) and process validation (PPQ).
• Proven track record of leading complex technical programs and cross-functional initiatives.
• Strong leadership, mentorship, and cross-functional collaboration skills.
• Strong written and verbal communication skills, including authoring technical documents and presenting to senior leadership.
• Candidates must be authorized to work in the U.S.

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. The expected salary range for this role is $155,000 - $180,000 per year. Actual pay will be determined based on experience, qualifications, geographic location, business needs, and other job-related factors permitted in 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.