Job Description
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 by law.
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