Director, Analytical Development

Century Therapeutics is developing novel allogeneic living cell products for oncology that overcome the limitations of current cell therapies. Century's genetically-engineered, universal iPSC-derived immune effector cell products are designed to specifically target hematologic and solid tumor cancers. Our commitment to developing off-the-shelf cell therapies will expand patient access and provide an unparalleled opportunity to advance the course of cancer care.

Century's foundational technology is built on induced pluripotent stem cells (iPSCs) that have unlimited self-renewing capacity. This enables complex cellular engineering to produce controlled cell banks of modified cells that can be expanded and differentiated into desired immune effector cells, which can supply vast amounts of allogeneic, homogeneous therapeutic products. This platform differentiates Century from other approaches that utilize non-renewable donor-derived cells.

Role:

The Director, Analytical Development is accountable for providing strategic and scientific guidance to the analytical team responsible for developing Century's quality control and characterization platform. With a focus on scientific and technical excellence, this group leader will oversee the selection of analytical technologies, establishment of analytical procedures, and the validation and transfer of methods in support of early development programs. This role will interact extensively with internal and external partners to advance pipeline programs through key CMC milestones.

This role is based in Philadelphia (University City), PA.

Responsibilities

• Provide strategic, technical, and scientific leadership to the Analytical Development team
• Function as an analytical lead in early development product teams to deliver on corporate objectives related to the advancement of the company's pipeline programs
• Define the product control strategy for Century's pipeline of genetically-engineered, iPSC-derived cell therapy products
• Foster the growth of analytical development capabilities, including the implementation of state-of-the-art, phase-appropriate methods in support of product and process characterization, comparability, and quality control activities
• Oversee execution of analytical method development, optimization, transfer, and validation under cGMP in collaboration with Quality Control in order
• Apply expertise in cell and molecular biology to analytical development over the course of the analytical procedure lifecycle and in support of technical investigations
• Author, review, and approve technical documents such as study protocols, methods, validation protocols and reports in collaboration with QC
• Responsible for resourcing, scheduling, and coordinating laboratory activities to meet organization objectives
• Ensure systems, processes, and resources are in place to conduct laboratory activities in compliance with cGMP/GLPs (as needed), SOPs, good documentation practices, and OSHA safety standards

Qualifications:

• Ph.D. in Biochemistry, Cell Biology, Molecular Biology, Biotechnology, Biological Sciences or related discipline
• At least 12 years relevant experience in biopharmaceutical assay development, with minimum 3 years in a managerial capacity

Requirements:

• Extensive experience in leading analytical activities to support IND, Phase I/II, pivotal, and commercial activities in the biotech or pharmaceutical industry
• Extensive experience in analytical method lifecycle management, including method development and validation per ICH Q2(R1) guidelines
• Demonstrated leadership skills, including the ability to manage a scientific team; work effectively within a matrix team; communicate, coach, and mentor employees
• Strong scientific reasoning, problem-solving, and technical skills in molecular and cell-based methods, including but not limited to PCR-based techniques, flow cytometry, and cell-based assays