Principal Scientist, Process Sciences

Responsibilities

• Lead the Pilot Plant team, overseeing execution of large-scale and engineering runs in support of process development, characterization, and technology transfer.
• 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.

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.