Cell Therapy PD Lead

GeneFab•Alameda, CA

6h•$150,000 - $220,000

About The Position

The Cell Therapy Lead will support technical strategy and execution of cell therapy projects, overseeing the entire process from initial cell isolation through to scale-up and cryopreservation. You will act as a subject matter expert and strategic lead, managing CMC activities, regulatory documentation, and the transition of open processes into closed, automated systems. Additionally, this role will serve as a mentor to staff and coordinate with colleagues across the GeneFab organization.

Requirements

BS/MS with 10+ years or PhD Degree with 8+ years of experience in science/engineering of biopharmaceutical or cell/gene therapy process development and technology transfer
Experience developing and optimizing cell therapy processes for GMP production from IND through late-stage clinical supply
Strong technical writing and communication skills to support multi-functional project teams and strategic management decisions
Strong critical thinking, organizational skills, leadership, and attention to detail

Responsibilities

Lead technical activities for cell therapy development projects, including experiment strategy, direct support of execution, data driven decision making, and coordination with multi-functional teams as needed.
Serve as a subject matter expert (SME) on cell therapy unit operations, including: evaluation of cell sources, isolation and activation of human immune cells, media optimization, viral/non-viral genetic modification, cell expansion, cell harvest/fill/finish, and cryopreservation.
Lead technology and platform development of cell therapy process scaleup, including: transition from open processes to closed automated systems, understanding analytical methods, using a Design of Experiments (DoE) approach, and evaluating process choices within a Quality by Design (QbD) framework.
Work closely with internal and external teams to provide strategic guidance on phase appropriate CMC strategy.
Represent process development team in updates to internal/external project teams and leadership.
Author and review study protocols, technical reports, ELNs, regulatory submissions.
Support authoring of key documentation to enable technology transfer (e.g. sampling plans, batch records, specifications, SOPs, FMEA, flow diagrams, etc.).
Serve as a technical resource/SME for GMP operations (e.g. root cause analyses and continuous improvement initiatives).
Manage project timelines and update stakeholders for progress against key milestones.
Direct management of process development employees, focused on mentorship and development. Coordinate and prioritize tasks across multiple projects.
Present on cell therapy project to internal and external audiences.